PlainRecalls

Stryker Instruments Div. of Stryker Corporation

Compiled from official public sources by the editorial team.

161 recalls on record · Latest: Jul 27, 2022

Stryker Instruments Div. of Stryker Corporation Recall Insight

Stryker Instruments Div. of Stryker Corporation appears on 161 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.158% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jul 27, 2022, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 48 moderate, and 2 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Aug 31, 2016 to Jul 27, 2022.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Jul 27, 2022

SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the numb…

FDA Devices Moderate Jul 27, 2022

Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032)…

FDA Devices Low Jul 27, 2022

Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6

FDA Devices Moderate Nov 18, 2020

Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access…

FDA Devices Moderate May 6, 2020

Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil)…

FDA Devices Moderate Feb 12, 2020

SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telesc…

FDA Devices Moderate Feb 12, 2020

Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. …

FDA Devices Moderate Feb 12, 2020

Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping …

FDA Devices Moderate Dec 11, 2019

Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 …

FDA Devices Moderate Dec 11, 2019

Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-13…

FDA Devices Moderate Oct 9, 2019

C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitori…

FDA Devices Moderate Oct 9, 2019

C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitori…

FDA Devices Moderate May 1, 2019

Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and …

FDA Devices Moderate May 2, 2018

T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment

FDA Devices Moderate May 2, 2018

T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment

FDA Devices Moderate May 2, 2018

T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment

FDA Devices Moderate May 2, 2018

T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment

FDA Devices Moderate May 2, 2018

T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment

FDA Devices Moderate May 2, 2018

T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment

FDA Devices Moderate May 2, 2018

T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment

FDA Devices Moderate May 2, 2018

T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment

FDA Devices Moderate May 2, 2018

T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment

FDA Devices Moderate May 2, 2018

T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment

FDA Devices Moderate May 2, 2018

T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment

FDA Devices Moderate Apr 4, 2018

Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.

FDA Devices Moderate Apr 4, 2018

Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.

FDA Devices Moderate Apr 4, 2018

PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.

FDA Devices Moderate Apr 4, 2018

11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.

FDA Devices Moderate Apr 4, 2018

10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.

FDA Devices Moderate Apr 4, 2018

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: (0…

FDA Devices Moderate Apr 4, 2018

Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for ortho…

FDA Devices Moderate Apr 4, 2018

1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hu…

FDA Devices Moderate Apr 4, 2018

Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.

FDA Devices Moderate Apr 4, 2018

1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01…

FDA Devices Moderate Apr 4, 2018

The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into …

FDA Devices Moderate Apr 4, 2018

Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.

FDA Devices Moderate Apr 4, 2018

1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial Hi…

FDA Devices Moderate Apr 4, 2018

180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.

FDA Devices Moderate May 17, 2017

Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guid…

FDA Devices Moderate May 3, 2017

Stryker SmartLife Large Aseptic Housing (7126-120-000)

FDA Devices Moderate Dec 28, 2016

8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseo…

FDA Devices Moderate Dec 28, 2016

8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove …

FDA Devices Moderate Dec 28, 2016

8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseo…

FDA Devices Moderate Dec 28, 2016

8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous mater…

FDA Devices Moderate Dec 28, 2016

8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseo…

FDA Devices Moderate Dec 28, 2016

8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove …

FDA Devices Moderate Dec 28, 2016

8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseo…

FDA Devices Low Nov 23, 2016

RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U

FDA Devices Moderate Oct 26, 2016

Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone and bone related tissue …

FDA Devices Moderate Aug 31, 2016

120 V Neptune 3 Rover, Model Number: 0703-001-000

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Stryker Instruments Div. of Stryker Corporation with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.