Stryker Instruments Div. of Stryker Corporation
Complete recall history across all FDA and CPSC categories — 161 total recalls
Stryker Instruments Div. of Stryker Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (161)
FDA medical device enforcement actions by Stryker Instruments Div. of Stryker Corporation. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jun 15, 2022 | SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-... | When scanning sponges out after a surgical procedure, an error may allow for ... | Class II |
| Oct 16, 2020 | Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, si... | Potential for the inner bit to contain a crack, that may or may not be visibl... | Class II |
| Mar 26, 2020 | Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Us... | Due to a distribution error, product from the affected lot was shipped expired. | Class II |
| Jan 22, 2020 | Triton Canister System (finished part numbers FG 12009, for 3L canisters, and... | Some Canister Scanning Labels used to calibrate the Triton Canister System ha... | Class II |
| Jan 13, 2020 | Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product ... | Hairline fractures in a component could allow electrical current to arc out o... | Class II |
| Jan 13, 2020 | Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bo... | Hairline fractures in a component could allow electrical current to arc out o... | Class II |
| Jan 13, 2020 | SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The pr... | Hairline fractures in a component could allow electrical current to arc out o... | Class II |
| Nov 6, 2019 | Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder... | There is a potential for the cuff to leak air leading to a loss of vascular o... | Class II |
| Nov 6, 2019 | Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder... | There is a potential for the cuff to leak air leading to a loss of vascular o... | Class II |
| Jul 31, 2019 | C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usag... | Stryker C2 NerveMonitor's design and instructions may not optimally address u... | Class II |
| Jul 31, 2019 | C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usag... | Stryker C2 NerveMonitor's design and instructions may not optimally address u... | Class II |
| Mar 19, 2019 | Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usa... | During manufacture, packaging materials for a small portion of the lot may no... | Class II |
| Dec 4, 2018 | Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6 | Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Spon... | Class III |
| Feb 23, 2018 | T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-1... | Separation of material layers may occur, causing a potential risk of exposure... | Class II |
| Feb 23, 2018 | T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal prote... | Separation of material layers may occur, causing a potential risk of exposure... | Class II |
| Feb 23, 2018 | T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal pr... | Separation of material layers may occur, causing a potential risk of exposure... | Class II |
| Feb 23, 2018 | T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal prot... | Separation of material layers may occur, causing a potential risk of exposure... | Class II |
| Feb 23, 2018 | T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal pro... | Separation of material layers may occur, causing a potential risk of exposure... | Class II |
| Feb 23, 2018 | T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protec... | Separation of material layers may occur, causing a potential risk of exposure... | Class II |
| Feb 23, 2018 | T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal prote... | Separation of material layers may occur, causing a potential risk of exposure... | Class II |
| Feb 23, 2018 | T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal prote... | Separation of material layers may occur, causing a potential risk of exposure... | Class II |
| Feb 23, 2018 | T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-1... | Separation of material layers may occur, causing a potential risk of exposure... | Class II |
| Feb 23, 2018 | T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal prote... | Separation of material layers may occur, causing a potential risk of exposure... | Class II |
| Feb 23, 2018 | T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protecti... | Separation of material layers may occur, causing a potential risk of exposure... | Class II |
| Nov 9, 2017 | 180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206... | Lack of sterility assurance as bioburden levels were found to be higher than ... | Class II |
| Nov 9, 2017 | 1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-... | Lack of sterility assurance as bioburden levels were found to be higher than ... | Class II |
| Nov 9, 2017 | Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)45... | Lack of sterility assurance as bioburden levels were found to be higher than ... | Class II |
| Nov 9, 2017 | 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. ... | Lack of sterility assurance as bioburden levels were found to be higher than ... | Class II |
| Nov 9, 2017 | Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)45465400394... | Lack of sterility assurance as bioburden levels were found to be higher than ... | Class II |
| Nov 9, 2017 | 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-... | Lack of sterility assurance as bioburden levels were found to be higher than ... | Class II |
| Nov 9, 2017 | Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Pre... | Lack of sterility assurance as bioburden levels were found to be higher than ... | Class II |
| Nov 9, 2017 | 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)761325250... | Lack of sterility assurance as bioburden levels were found to be higher than ... | Class II |
| Nov 9, 2017 | 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)76132... | Lack of sterility assurance as bioburden levels were found to be higher than ... | Class II |
| Nov 9, 2017 | 11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01... | Lack of sterility assurance as bioburden levels were found to be higher than ... | Class II |
| Nov 9, 2017 | PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UD... | Lack of sterility assurance as bioburden levels were found to be higher than ... | Class II |
| Nov 9, 2017 | Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: ... | Lack of sterility assurance as bioburden levels were found to be higher than ... | Class II |
| Nov 9, 2017 | Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 060... | Lack of sterility assurance as bioburden levels were found to be higher than ... | Class II |
| Oct 16, 2017 | The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for re... | Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily reca... | Class II |
| Mar 10, 2017 | Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a ... | Product shipped proximate to or past the expiration date listed on the produc... | Class II |
| Feb 28, 2017 | Stryker SmartLife Large Aseptic Housing (7126-120-000) | Stryker Instruments issued a notice of correction for an update to cleaning p... | Class II |
| Nov 30, 2016 | 8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MI... | Stryker Instruments is voluntarily recalling specific lots of sterile MIS Too... | Class II |
| Nov 30, 2016 | 8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile The Stryk... | Stryker Instruments is voluntarily recalling specific lots of sterile MIS Too... | Class II |
| Nov 30, 2016 | 8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MI... | Stryker Instruments is voluntarily recalling specific lots of sterile MIS Too... | Class II |
| Nov 30, 2016 | 8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minim... | Stryker Instruments is voluntarily recalling specific lots of sterile MIS Too... | Class II |
| Nov 30, 2016 | 8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile The Stryker MI... | Stryker Instruments is voluntarily recalling specific lots of sterile MIS Too... | Class II |
| Nov 30, 2016 | 8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryk... | Stryker Instruments is voluntarily recalling specific lots of sterile MIS Too... | Class II |
| Nov 30, 2016 | 8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile The Stryker MI... | Stryker Instruments is voluntarily recalling specific lots of sterile MIS Too... | Class II |
| Oct 11, 2016 | RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U | Stryker Instruments is voluntarily recalling the Care Instructions/Instructio... | Class III |
| Aug 17, 2016 | Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: ... | Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM... | Class II |
| Jul 1, 2016 | 120 V Neptune 3 Rover, Model Number: 0703-001-000 | Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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