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

View all 161 device recalls →

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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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