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Stryker Instruments Div. of Stryker Co
Stryker Instruments Div. of Stryker Corporation: 161 FDA recall reports
Every medical device recall the FDA has published for Stryker Instruments Div. of Stryker Corporation. The fault, and how the agency graded it.
161Reports
4Class I
0Ongoing
2022-07-27Most recent
4 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.
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, disp
Z-1452-2022 · Class II · reported 2022-07-27 · Terminated
- Why it was recalled
- When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error.
- Product
- SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
- Where it went
- The products were distributed to the following US states: KS and ME.
- How much
- 44 units
Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scann
Z-1402-2022 · Class II · reported 2022-07-27 · Terminated
- Why it was recalled
- Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower than expected results.
- Product
- Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories.
- Where it went
- US Nationwide
- How much
- 16,700 units
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Z-1394-2022 · Class III · reported 2022-07-27 · Terminated
- Why it was recalled
- Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.
- Product
- Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
- Where it went
- US Nationwide.
- How much
- 51 units
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intend
Z-0431-2021 · Class II · reported 2020-11-18 · Terminated
- Why it was recalled
- Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.
- Product
- Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001
- Where it went
- Nationwide Foreign: Australia Brazil Canada Chile Colombia Hong Kong Italy Mexico Netherlands Netherlands New Zealand South Africa South Korea Spain Sweden Switzerland United Kingdom
- How much
- 18,492 devices. Expanded Recall total: 18,594 devices
Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Inte
Z-1807-2020 · Class II · reported 2020-05-06 · Terminated
- Why it was recalled
- Due to a distribution error, product from the affected lot was shipped expired.
- Product
- Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
- Where it went
- International distribution the country of Canada.
- How much
- 40 units
SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 7
Z-1097-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
- Product
- SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
- Where it went
- Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.
- How much
- 15150
Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long
Z-1099-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
- Product
- Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
- Where it went
- Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.
- How much
- 15150
Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75 inch
Z-1098-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
- Product
- Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
- Where it went
- Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.
- How much
- 15150
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect
Z-0593-2020 · Class II · reported 2019-12-11 · Terminated
- Why it was recalled
- There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
- Product
- Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.
- Where it went
- Worldwide distributions - US Nationwide distributions in the states of AL, CD, HI, IA, ID, IN, KS, KY, MA, ME, MI, MN, MT, NC, NE, NH, NJ, NV, NY, OK, OR, PA, SC, SD, TN, VA, WI, WV, and WY. Countries of Argentina, Australia, Canada, and Netherlands.
- How much
- 16,380 total
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connec
Z-0592-2020 · Class II · reported 2019-12-11 · Terminated
- Why it was recalled
- There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
- Product
- Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.
- Where it went
- Worldwide distributions - US Nationwide distributions in the states of AL, CD, HI, IA, ID, IN, KS, KY, MA, ME, MI, MN, MT, NC, NE, NH, NJ, NV, NY, OK, OR, PA, SC, SD, TN, VA, WI, WV, and WY. Countries of Argentina, Australia, Canada, and Netherlands.
- How much
- 16,380 total
C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System i
Z-0024-2020 · Class II · reported 2019-10-09 · Terminated
- Why it was recalled
- Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contributing to nerve injury.
- Product
- C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
- Where it went
- US Nationwide distribution.
- How much
- 135
C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System i
Z-0023-2020 · Class II · reported 2019-10-09 · Terminated
- Why it was recalled
- Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contributing to nerve injury.
- Product
- C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
- Where it went
- US Nationwide distribution.
- How much
- 135
Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagit
Z-1215-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.
- Product
- Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder, ankle and orthopedic trauma procedures. The intended part of the body will be the areas associated with the above procedures. These products will be used in a fully equipped OR suite by surgeons.
- Where it went
- US Nationwide in the states of: FL, GA, ID, KY, MA, MD, MN, NC, PA, UT, WA, and WI. The products were distributed to the following foreign countries: Canada, France, Italy, Netherlands.
- How much
- 355
T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
Z-1505-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- Product
- T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
- Where it went
- US Nationwide and Ireland, Japan, South Korea, UK
- How much
- 34570 total products
T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment
Z-1509-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- Product
- T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment
- Where it went
- US Nationwide and Ireland, Japan, South Korea, UK
- How much
- 34570 total products
T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection g
Z-1510-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- Product
- T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment
- Where it went
- US Nationwide and Ireland, Japan, South Korea, UK
- How much
- 34570 total products
T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment
Z-1501-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- Product
- T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment
- Where it went
- US Nationwide and Ireland, Japan, South Korea, UK
- How much
- 34570 total products
T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment
Z-1508-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- Product
- T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment
- Where it went
- US Nationwide and Ireland, Japan, South Korea, UK
- How much
- 34570 total products
T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
Z-1506-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- Product
- T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
- Where it went
- US Nationwide and Ireland, Japan, South Korea, UK
- How much
- 34570 total products
T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
Z-1504-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- Product
- T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
- Where it went
- US Nationwide and Ireland, Japan, South Korea, UK
- How much
- 34570 total products
T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment
Z-1500-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- Product
- T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment
- Where it went
- US Nationwide and Ireland, Japan, South Korea, UK
- How much
- 34,570 total products
T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment
Z-1502-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- Product
- T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment
- Where it went
- US Nationwide and Ireland, Japan, South Korea, UK
- How much
- 34570 total products
T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment
Z-1503-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- Product
- T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment
- Where it went
- US Nationwide and Ireland, Japan, South Korea, UK
- How much
- 34570 total products
T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection g
Z-1507-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- Product
- T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment
- Where it went
- US Nationwide and Ireland, Japan, South Korea, UK
- How much
- 34570 total products
Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114
Z-1252-2018 · Class II · reported 2018-04-04 · Terminated
- Why it was recalled
- Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
- Product
- Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.
- Where it went
- Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
- How much
- 732
Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthoped
Z-1255-2018 · Class II · reported 2018-04-04 · Terminated
- Why it was recalled
- Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
- Product
- Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
- Where it went
- Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
- How much
- 320
PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal
Z-1249-2018 · Class II · reported 2018-04-04 · Terminated
- Why it was recalled
- Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
- Product
- PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
- Where it went
- Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
- How much
- 12
11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orth
Z-1247-2018 · Class II · reported 2018-04-04 · Terminated
- Why it was recalled
- Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
- Product
- 11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
- Where it went
- Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
- How much
- 900
10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic
Z-1253-2018 · Class II · reported 2018-04-04 · Terminated
- Why it was recalled
- Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
- Product
- 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
- Where it went
- Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
- How much
- 51
1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit
Z-1254-2018 · Class II · reported 2018-04-04 · Terminated
- Why it was recalled
- Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
- Product
- 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 for spinal orthopedic use.
- Where it went
- Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
- How much
- 504
Showing the 30 most recent of 161. 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.
← All device recalls