Medtronic Xomed, Inc.: 26 FDA recall reports
Every medical device recall the FDA has published for Medtronic Xomed, Inc.. The fault, and how the agency graded it.
26Reports
5Class I
17Ongoing
2025-09-03Most recent
5 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indi
Z-2461-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- Due to out of the box wobble of the driver.
- Product
- IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE System is also used in the placement of screws, or cutting of screws, posts, and rods. The IPC is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
- Where it went
- U.S.: AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, SC, TN, TX, O.U.S.: Canada, China, Croatia, France, Germany, India, Italy, Japan, Jordan, Kuwait, Norway, Romania, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom
- How much
- 214
NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REF
Z-1623-2025 · Class II · reported 2025-04-30 · Ongoing
- Why it was recalled
- Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
- Product
- NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143; SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154; SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164
- Where it went
- Worldwide - US Nationwide distribution including in the states of MD, MN, PA, OK, OH, FL, CO, GA, NC, KS, IL, WY, AK, NE, VA, MI, CA, NY, WI, UT, AZ, AR, TX, WA, AL, NJ, SD, MS, KY, TN, MO, OR, MT, MA, CT, NM, LA, WV, NH, DC, DE, IN, NV, IA, SC, ID, ME, HI, RI, VT, ND, GU, PR and the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Namibia, Nepal, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam.
- How much
- 9,788
Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Z-3130-2024 · Class II · reported 2024-09-18 · Ongoing
- Why it was recalled
- Product was distributed past expiration date.
- Product
- Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
- Where it went
- International distribution to the country of Canada.
- How much
- 1 unit
Class I
NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v
Z-2409-2024 · Class I · reported 2024-07-31 · Ongoing
- Why it was recalled
- Potential for false negative response on the NIM Vital Nerve Monitoring System
- Product
- NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Model Number: NIM4CM01RF, 3. PATIENT INTERFACE NIM4CPB1 NIM 4.0, Model Number: NIM4CPB1, 4. PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, Model Number: NIM4CPB1RF, 5. SOFTWARE NIM4SWU143 UPGRADE V1.4.3, Model Number: NIM4SWU143
- Where it went
- Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic Of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam.
- How much
- 7,804 units
NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0
Z-0696-2024 · Class II · reported 2024-01-17 · Ongoing
- Why it was recalled
- Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
- Product
- NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8229738, 8MM ID 3 PK
- Where it went
- Worldwide distribution.
- How much
- 80569 units
Class I
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
Z-1520-2022 · Class I · reported 2022-09-07 · Ongoing
- Why it was recalled
- The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
- Product
- NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
- Where it went
- Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Islamic Republic Of, Ireland, Israel, Italy, Japan, Korea, Republic Of, Kosovo, Kuwait, Libya, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, North Macedonia, Northern Mariana Islands, Norway, Oman, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Slovakia, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam
- How much
- 1,133,612 units
Class I
NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
Z-1519-2022 · Class I · reported 2022-09-07 · Ongoing
- Why it was recalled
- The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
- Product
- NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
- Where it went
- Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Islamic Republic Of, Ireland, Israel, Italy, Japan, Korea, Republic Of, Kosovo, Kuwait, Libya, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, North Macedonia, Northern Mariana Islands, Norway, Oman, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Slovakia, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam
- How much
- 81,555 units
Class I
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
Z-1521-2022 · Class I · reported 2022-09-07 · Ongoing
- Why it was recalled
- The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
- Product
- NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
- Where it went
- Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Islamic Republic Of, Ireland, Israel, Italy, Japan, Korea, Republic Of, Kosovo, Kuwait, Libya, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, North Macedonia, Northern Mariana Islands, Norway, Oman, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Slovakia, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam
- How much
- 23,820 units
NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Z-1224-2022 · Class II · reported 2022-06-08 · Ongoing
- Why it was recalled
- Software anomaly was identified.
- Product
- NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.
- How much
- 29 units
NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
Z-1223-2022 · Class II · reported 2022-06-08 · Ongoing
- Why it was recalled
- Software anomaly was identified.
- Product
- NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.
- How much
- 18 units
Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOL
Z-0961-2022 · Class II · reported 2022-04-27 · Terminated
- Why it was recalled
- As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece.
- Product
- Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300
- Where it went
- International distribution country of Japan.
- How much
- 1447 units
NIM TRIVANTAGE EMG Endotracheal Tube
Z-0743-2022 · Class II · reported 2022-03-16 · Ongoing
- Why it was recalled
- There is potential for multiple issues due to a manufacturing nonconformity.
- Product
- NIM TRIVANTAGE EMG Endotracheal Tube
- Where it went
- Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Faroe Islands, Finland, France, French Guinea, Germany, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea (Republic of), Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mauritius, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, North Macedonia, Norway, Panama, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam.
- How much
- 301,926 devices
Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT
Z-0158-2022 · Class II · reported 2021-10-27 · Ongoing
- Why it was recalled
- There was an increase in complaints related to tip breaks and wobble/vibration.
- Product
- Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 40A2500, Nucleus Removal Angled Blade, 25 cm x 4.0 mm; (2) REF 40R2000, Nucleus Removal Set, 20 cm x 4.0 mm; (3) REF 40R2500, Nucleus Removal Set, 25 cm x 4.0 mm; (4) REF 40S2000, Nucleus Removal Straight Blade, 20 cm x 4.0 mm; (5) REF 40S2500, Nucleus Removal Straight Blade, 25 cm x 4.0 mm; (6) REF 45A2000, Nucleus Removal Angled Blade, 20 cm x 4.5 mm; (7) REF 45A2500, Nucleus Removal Angled Blade, 25 cm x 4.5 mm; (8) REF 45R2000, Nucleus Removal Set, 20 cm x 4.5 mm; (9) REF 45R2500, Nucleus Removal Set, 25 cm x 4.5 mm; (10) REF 45S2000, Nucleus Removal Straight Blade, 20 cm x 4.5 mm; (11) REF 45S2500, Nucleus Removal Straight Blade, 25 cm x 4.5 mm.
- Where it went
- Worldwide distribution - US Nationwide, including PR. There was also government/military distribution and the countries of Australia, Austria, Bahrain, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kuwait, Latvia, Libya, Luxembourg, Macao, Malaysia, Mauritius, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Viet Nam.
- How much
- 274,991 total devices
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT
Z-0157-2022 · Class II · reported 2021-10-27 · Ongoing
- Why it was recalled
- There was an increase in complaints related to tip breaks and wobble/vibration.
- Product
- Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1883080EM, Rotatable Fusion Blade, Quadcut 3.0 mm x 13 cm; (2) REF 1883480EM, Rotatable Fusion Blade, Quadcut, 3.4 mm x 13 cm; (3) REF 1884006EM, Rotatable Fusion Blade, RAD 40; (4) REF 1884012EM, Rotatable Fusion Blade, RAD 12; (5) REF 1884080EM, Rotatable Fusion Blade, Tricut, 13 cm; (6) REF 1884380EM, Rotatable Fusion Blade, Quadcut, 4.3 mm x 13 cm.
- Where it went
- Worldwide distribution - US Nationwide, including PR. There was also government/military distribution and the countries of Australia, Austria, Bahrain, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kuwait, Latvia, Libya, Luxembourg, Macao, Malaysia, Mauritius, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Viet Nam.
- How much
- 274,991 total devices
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT
Z-0156-2022 · Class II · reported 2021-10-27 · Ongoing
- Why it was recalled
- There was an increase in complaints related to tip breaks and wobble/vibration.
- Product
- Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm; (2) REF 1883514, RAD 12 Curved Sinus Blade, 11 cm x 3.5 mm; (3) REF 1884013, Powered Tonsillectomy Blade, 11 cm x 4 mm; (4) REF 1884020, Tricut Laryngeal Blade, 22.5 cm x 4 mm; (5) REF 1884032, Tracheal Blade, 37 cm x 4 mm; (6) REF 1884033, Tracheal Blade, Angle Tip; (7) REF 1882902HRE, Serrated Blade, 11 cm X 2.9 mm, Rotatable; (8) REF 1882905HRE, Silver Bullet Blade, 11 cm x 2.9 mm, Rotatable; (9) REF 1882924HRE, Skimmer Blade, 27 cm x 2.9 mm, Rotatable; (10) REF 1882936E, Angle-Tip Serrated Blade, 18 cm x 2.9 mm; (11) REF 1882937E, Angle-Tip Serrated Blade, 22 cm x 2.9 mm; (12) REF 1882979HRE, Skimmer Blade, 13 cm x 2.9 mm, Rotatable; (13) REF 1883080HRE, Quadcut Blade, 3.0 mm, Rotatable; (14) REF 1883480HRE, Quadcut Blade, 3.4 mm, Rotatable; (15) REF 1883502HRE, Serrated Blade, 11 cm x 3.5 mm, Rotatable; (16) REF 1883506HRE, RAD 40 Blades, 11 cm x 3.5 mm, Rotatable; (17) REF 1883512HRE, RAD 12...
- Where it went
- Worldwide distribution - US Nationwide, including PR. There was also government/military distribution and the countries of Australia, Austria, Bahrain, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kuwait, Latvia, Libya, Luxembourg, Macao, Malaysia, Mauritius, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Viet Nam.
- How much
- 274,991 total devices
Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting r
Z-2673-2020 · Class II · reported 2020-07-29 · Terminated
- Why it was recalled
- During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the cosole.
- Product
- Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.
- Where it went
- Worldwide distribution - US Nationwide distribution including in the states of AL, AK, AZ, AR, CA,CO, CT, FL, GA, HI, ID,IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, PA, RI, SC, TN, TX, UT, VA, WV, WA, WI. The countries of Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Greece, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, Sweden, Switzerland, United Kingdom.
- How much
- 673 units
Lamicel 10PK 10MM INTL
Z-0735-2020 · Class II · reported 2020-01-01 · Ongoing
- Why it was recalled
- Routine sterilization dose does not meet the required Sterility Assurance Level.
- Product
- Lamicel 10PK 10MM INTL
- Where it went
- Affected product was only distributed in Japan.
- How much
- 10 packs; 100 units
Lamicel 20PK 5MM INTL
Z-0734-2020 · Class II · reported 2020-01-01 · Ongoing
- Why it was recalled
- Routine sterilization dose does not meet the required Sterility Assurance Level.
- Product
- Lamicel 20PK 5MM INTL
- Where it went
- Affected product was only distributed in Japan.
- How much
- 307 packs; 6140 units
Lamicel 20PK 3MM INTL Cervical dilator
Z-0733-2020 · Class II · reported 2020-01-01 · Ongoing
- Why it was recalled
- Routine sterilization dose does not meet the required Sterility Assurance Level.
- Product
- Lamicel 20PK 3MM INTL Cervical dilator
- Where it went
- Affected product was only distributed in Japan.
- How much
- 29320 units
NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually pack
Z-0901-2017 · Class II · reported 2017-01-04 · Terminated
- Why it was recalled
- Wire in tubing can become exposed, posing potential harm to the intubated patient.
- Product
- NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
- Where it went
- Worldwide Distribution - Nationwide Distribution including US Virgin Island and Puerto Rico , and to the countries of :Japan, Korea, China, Canada, Dominican Republic, Colombia, Chile, Costa Rica, Bahamas, Peru, Panama, Mexico, Argentina, Ecuador, Brazil, Trinidad and Tobago, Hong Kong, Taiwan, United Kingdom, Netherlands, Sri Lanka, Austria, Italy, Germany, United Arab Emirates, Saudi Arabia, Kuwait, France, Belgium, Oman, Ireland, Azerbaijan, India, Spain, Portugal, Luxembourg, Switzerland, Russian Federation, Austria, Greece, Cyprus, Portugal, India, Algeria, Iceland, Iran, Denmark, Hungary, Czech Republic, Ukraine, Turkey, Croatia, Israel, Norway, Oman, Sweden, Libya, Finland, Spain, Portugal, Algeria, Morocco, Poland, Canada, Malaysia, Singapore, Australia, and New Zealand
- How much
- 3752
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and
Z-2284-2013 · Class II · reported 2013-10-02 · Terminated
- Why it was recalled
- One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
- Product
- Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
- Where it went
- Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
- How much
- 60
Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical ins
Z-1934-2013 · Class II · reported 2013-08-21 · Terminated
- Why it was recalled
- The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY"
- Product
- Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.
- Where it went
- Worldwide Distribution - USA (nationwide) Nationwide, Hawaii, Puerto Rico and Guam. Internationally to: Canada, Austria, Belgium, Cyprus, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Morocco, Netherlands, Nigeria, Portugal, Qatar, Reunion, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Australia, New Zealand, Singapore, Thailand, Vietnam, China, Hong Kong,Taiwan, Korea, Japan, Brazil, Chile, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Nicaragua, and Venezuela.
- How much
- 3,562 trays
Class I
REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Sou
Z-1420-2013 · Class I · reported 2013-06-12 · Terminated
- Why it was recalled
- In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the continued ventilation of the patient.
- Product
- REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to a multi-channel EMG neuromonitoring device.
- Where it went
- Worldwide distribution: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, MD, MI, MN, MT, NC, NH, NJ, NY, OH, PA, RI, SC, TX, UT, VA, and WA; and countries of : Australia, Canada, Germany, Italy, Norway, Poland and United Kingdom.
- How much
- 2,591 units
Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (N
Z-2343-2012 · Class II · reported 2012-09-19 · Terminated
- Why it was recalled
- In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
- Product
- Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" Bottom/Underside of unit is labeled in part: "***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***" Cord is labeled in part: "***Ref.***Mfg Date***Sn***" The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.
- Where it went
- Worldwide distribution: USA (nationwide) and countries of: Australia, Austria, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Lebanon, Libya, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudia Arabia, Singapore, Slovak, Spain, SRI Lanka, Sweden, Turkey, United Arab Emirates, and United Kingdom.
- How much
- 53
Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Respo
Z-2342-2012 · Class II · reported 2012-09-19 · Terminated
- Why it was recalled
- In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
- Product
- Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" Bottom/Underside of unit is labeled in part: "***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***" Cord is labeled in part: "***Ref.***Mfg Date***Sn***" The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.
- Where it went
- Worldwide distribution: USA (nationwide) and countries of: Australia, Austria, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Lebanon, Libya, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudia Arabia, Singapore, Slovak, Spain, SRI Lanka, Sweden, Turkey, United Arab Emirates, and United Kingdom.
- How much
- 464
Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (P
Z-2344-2012 · Class II · reported 2012-09-19 · Terminated
- Why it was recalled
- In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
- Product
- Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse). LABELING: Box Label: REF 8253210 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" Bottom/Underside of unit is labeled in part: "***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***" Cord is labeled in part: "***Ref.***Mfg Date***Sn***" The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.
- Where it went
- Worldwide distribution: USA (nationwide) and countries of: Australia, Austria, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Lebanon, Libya, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudia Arabia, Singapore, Slovak, Spain, SRI Lanka, Sweden, Turkey, United Arab Emirates, and United Kingdom.
- How much
- 7
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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