Stryker Corporation: 110 FDA recall reports
Every medical device recall the FDA has published for Stryker Corporation. The fault, and how the agency graded it.
110Reports
0Class I
83Ongoing
2026-06-10Most recent
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.
Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System
Z-2282-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable.
- Product
- Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System
- Where it went
- US Nationwide distribution in the state of Indiana.
- How much
- 1 unit
Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are i
Z-2166-2026 · Class II · reported 2026-05-20 · Ongoing
- Why it was recalled
- Due to nonconforming products being inadvertently distributed.
- Product
- Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.
- Where it went
- U.S. Nationwide distribution in the state of GA.
- How much
- 10 tube sets
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTI
Z-1427-2026 · Class II · reported 2026-02-25 · Ongoing
- Why it was recalled
- Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.
- Product
- MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.
- Where it went
- Worldwide - U.S. Nationwide distribution including in the states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. The countries of Canada, Singapore, Panama, Jamaica, and Cayman Islands.
- How much
- 5,864
NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 Brai
Z-0601-2026 · Class II · reported 2025-12-03 · Ongoing
- Why it was recalled
- Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
- Product
- NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BrainPath Shephard's Hook - Greenberg LK;
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.
- How much
- 39,148
NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 1
Z-0599-2026 · Class II · reported 2025-12-03 · Ongoing
- Why it was recalled
- Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
- Product
- NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAAB; NN-8006 11X10 MHP; NN-8007 11x13 MHP; NN-8008 19x28 MHP OI; NN-8010 17x31.5 MHP DECQ; NN-8015 NICO Fluid System (NFS); NN-8017 11x13 MHP/PB; NN-8018 13X13 MHP/PB; NN-8019 19x28 MHP Little LOTTA; NN-8020 19x21.5 MHP PaediScope; NN-8021 15x26.5 MHP LOTTA; NN-8500 15x10 MHP; NN-8501 15x13 MHP; NN-8502 15x25 MINOP MHP; NN-8503 13x10 MHP; NN-8504 13x13 MHP; NN-8505 15x25 GAAB MHP; NN-8506 11X10 MHP; NN-8507 11x13 MHP; NN-8508 19x28 OI MHP; NN-8510 17x31.5 DECQ MHP; NN-8517 13X13 MHP/PB; NN-8518 11x13 MHP/PB; NN-8519 19x28 Little LOTTA MHP; NN-8520 19x21.5 PaediScope MHP; NN-8521 15X26.5 LOTTA MHP;
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.
- How much
- 39,148
NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g
Z-0600-2026 · Class II · reported 2025-12-03 · Ongoing
- Why it was recalled
- Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
- Product
- NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.
- How much
- 39,148
Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135;
Z-2277-2025 · Class II · reported 2025-08-13 · Ongoing
- Why it was recalled
- Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.
- Product
- Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235
- Where it went
- Domestic US distribution nationwide. International distribution to Australia Canada Hong Kong India Malaysia Netherlands New Zealand Singapore Sweden Thailand United Kingdom
- How much
- 233.230
Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
Z-2171-2025 · Class II · reported 2025-07-30 · Ongoing
- Why it was recalled
- Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
- Product
- Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
- Where it went
- Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Argentina, Philippines, Singapore, China, Japan, Canada, Korea.
- How much
- N/A
Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
Z-2170-2025 · Class II · reported 2025-07-30 · Ongoing
- Why it was recalled
- Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
- Product
- Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
- Where it went
- Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Argentina, Philippines, Singapore, China, Japan, Canada, Korea.
- How much
- N/A
Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-
Z-1472-2025 · Class II · reported 2025-04-09 · Ongoing
- Why it was recalled
- There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Product
- Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
- Where it went
- US Nationwide distribution.
- How much
- 182,344 total units
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
Z-1476-2025 · Class II · reported 2025-04-09 · Ongoing
- Why it was recalled
- There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Product
- Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
- Where it went
- US Nationwide distribution.
- How much
- 182,344 total units
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-10
Z-1475-2025 · Class II · reported 2025-04-09 · Ongoing
- Why it was recalled
- There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Product
- Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
- Where it went
- US Nationwide distribution.
- How much
- 182,344 total units
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
Z-1477-2025 · Class II · reported 2025-04-09 · Ongoing
- Why it was recalled
- There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Product
- Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
- Where it went
- US Nationwide distribution.
- How much
- 182,344 total units
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
Z-1482-2025 · Class II · reported 2025-04-09 · Ongoing
- Why it was recalled
- There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Product
- Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
- Where it went
- US Nationwide distribution.
- How much
- 182,344 total units
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
Z-1471-2025 · Class II · reported 2025-04-09 · Ongoing
- Why it was recalled
- There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Product
- Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
- Where it went
- US Nationwide distribution.
- How much
- 182,344 total units
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK
Z-1481-2025 · Class II · reported 2025-04-09 · Ongoing
- Why it was recalled
- There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Product
- Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
- Where it went
- US Nationwide distribution.
- How much
- 182,344 total units
Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-0
Z-1473-2025 · Class II · reported 2025-04-09 · Ongoing
- Why it was recalled
- There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Product
- Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
- Where it went
- US Nationwide distribution.
- How much
- 182,344 total units
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
Z-1470-2025 · Class II · reported 2025-04-09 · Ongoing
- Why it was recalled
- There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Product
- Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
- Where it went
- US Nationwide distribution.
- How much
- 182,344 total units
Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Cata
Z-1478-2025 · Class II · reported 2025-04-09 · Ongoing
- Why it was recalled
- There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Product
- Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
- Where it went
- US Nationwide distribution.
- How much
- 182,344 total units
Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Cata
Z-1479-2025 · Class II · reported 2025-04-09 · Ongoing
- Why it was recalled
- There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Product
- Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL
- Where it went
- US Nationwide distribution.
- How much
- 182,344 total units
Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-0
Z-1474-2025 · Class II · reported 2025-04-09 · Ongoing
- Why it was recalled
- There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Product
- Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
- Where it went
- US Nationwide distribution.
Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
Z-1469-2025 · Class II · reported 2025-04-09 · Ongoing
- Why it was recalled
- There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Product
- Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
- Where it went
- US Nationwide distribution.
- How much
- 182,344 total units
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK
Z-1480-2025 · Class II · reported 2025-04-09 · Ongoing
- Why it was recalled
- There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Product
- Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
- Where it went
- US Nationwide distribution.
- How much
- 182,344 total units
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE
Z-1328-2025 · Class II · reported 2025-03-19 · Ongoing
- Why it was recalled
- Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
- Product
- Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
- Where it went
- Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Argentina, Colombia, Netherlands, Spain, Mexico, Australia, United Kingdom, Brazil.
- How much
- 9521 units
stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
Z-1139-2025 · Class II · reported 2025-02-19 · Ongoing
- Why it was recalled
- Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
- Product
- stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
- Where it went
- Worldwide distribution.
- How much
- 238 units
stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
Z-1138-2025 · Class II · reported 2025-02-19 · Ongoing
- Why it was recalled
- Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
- Product
- stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
- Where it went
- Worldwide distribution.
- How much
- 622 units
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
Z-0981-2025 · Class II · reported 2025-01-29 · Ongoing
- Why it was recalled
- There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
- Product
- stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
- Where it went
- Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.
- How much
- 464 units
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurge
Z-0982-2025 · Class II · reported 2025-01-29 · Ongoing
- Why it was recalled
- There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
- Product
- stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
- Where it went
- Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.
- How much
- 1489 units
The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement du
Z-0980-2025 · Class II · reported 2025-01-29 · Ongoing
- Why it was recalled
- There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).
- Product
- The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/ Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries. The 3.0MM Prec Neuro Match Head bur (5820-107-530) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries. These burs are sold as single use devices without their own IFU.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Colombia, Sweden, Netherlands, UK.
- How much
- 491 devices
100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLIS
Z-0807-2025 · Class II · reported 2025-01-15 · Ongoing
- Why it was recalled
- Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction force or loss of suction during a procedure.
- Product
- 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)
- Where it went
- US (Domestic) distribution to states of: WA, GA, and IL. OUS (International) distribution to Japan and Netherlands.
- How much
- 14 (Expanded to 21 units on 10/9/25)
Showing the 30 most recent of 110. The rest are searchable at the FDA enforcement report database.
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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