Stryker Corporation

Complete recall history across all FDA and CPSC categories — 108 total recalls

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 (108)

FDA medical device enforcement actions by Stryker Corporation. Showing most recent 50.

Date Product Reason Class
May 6, 2026 Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of th... It has been identified that the impacted docking station (SN 2521008873) was ... Class II
Apr 9, 2026 Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 ... Due to nonconforming products being inadvertently distributed. Class II
Jan 21, 2026 MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm... Due to a need to update the product labeling (Instructions for Use IFU) as a ... Class II
Oct 31, 2025 NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve... Tape used to secure components within packaging contains latex, despite produ... Class II
Oct 31, 2025 NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; ... Tape used to secure components within packaging contains latex, despite produ... Class II
Oct 31, 2025 NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's... Tape used to secure components within packaging contains latex, despite produ... Class II
Jul 2, 2025 Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1B... Tourniquet cuff flange may become detached from the bladder. If leak occurs d... Class II
Jun 18, 2025 Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator withou... Due to complaints their is the potential that irrigation solution may leaked... Class II
Jun 18, 2025 Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Di... Due to complaints their is the potential that irrigation solution may leaked... Class II
Feb 25, 2025 Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-21... There is a potential for blister seals on the product to present a bubble on ... Class II
Feb 25, 2025 Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 a... There is a potential for blister seals on the product to present a bubble on ... Class II
Feb 25, 2025 Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 an... There is a potential for blister seals on the product to present a bubble on ... Class II
Feb 25, 2025 Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008... There is a potential for blister seals on the product to present a bubble on ... Class II
Feb 25, 2025 Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004... There is a potential for blister seals on the product to present a bubble on ... Class II
Feb 25, 2025 Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-0... There is a potential for blister seals on the product to present a bubble on ... Class II
Feb 25, 2025 Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 an... There is a potential for blister seals on the product to present a bubble on ... Class II
Feb 25, 2025 Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-21... There is a potential for blister seals on the product to present a bubble on ... Class II
Feb 25, 2025 Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-0... There is a potential for blister seals on the product to present a bubble on ... Class II
Feb 25, 2025 Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S There is a potential for blister seals on the product to present a bubble on ... Class II
Feb 25, 2025 Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-2... There is a potential for blister seals on the product to present a bubble on ... Class II
Feb 25, 2025 Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and... There is a potential for blister seals on the product to present a bubble on ... Class II
Feb 25, 2025 Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 540... There is a potential for blister seals on the product to present a bubble on ... Class II
Feb 25, 2025 Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 a... There is a potential for blister seals on the product to present a bubble on ... Class II
Jan 29, 2025 Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643... Increase in complaints concerning "pullwire" breakage that may result in the ... Class II
Jan 8, 2025 stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating an... Precision Thin blade attachments have a potential to be out of measurement sp... Class II
Jan 8, 2025 stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating an... Precision Thin blade attachments have a potential to be out of measurement sp... Class II
Dec 3, 2024 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-... Bolts on the vacuum pump filter housing and the flange plate were not properl... Class II
Oct 4, 2024 Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-... There is a potential for the product to activate without manual input when pl... Class II
Oct 4, 2024 Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push But... There is a potential for the product to activate without manual input when pl... Class II
Oct 4, 2024 Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk No... There is a potential for the product to activate without manual input when pl... Class II
Oct 4, 2024 Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70... There is a potential for the product to activate without manual input when pl... Class II
Oct 4, 2024 Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-B... There is a potential for the product to activate without manual input when pl... Class II
Oct 4, 2024 Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm -... There is a potential for the product to activate without manual input when pl... Class II
Sep 5, 2024 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming,... May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammat... Class II
Jul 24, 2024 Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in... Potential for the product to exhibit temperatures higher than specification w... Class II
Jul 24, 2024 Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the... Potential for the product to exhibit temperatures higher than specification w... Class II
Jul 24, 2024 Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the... Potential for the product to exhibit temperatures higher than specification w... Class II
Jul 24, 2024 Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the f... Potential for the product to exhibit temperatures higher than specification w... Class II
Jul 24, 2024 Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone ... Potential for the product to exhibit temperatures higher than specification w... Class II
Jul 24, 2024 Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone ... Potential for the product to exhibit temperatures higher than specification w... Class II
Jul 24, 2024 Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the ... Potential for the product to exhibit temperatures higher than specification w... Class II
Jul 24, 2024 Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone... Potential for the product to exhibit temperatures higher than specification w... Class II
Jul 24, 2024 Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the f... Potential for the product to exhibit temperatures higher than specification w... Class II
Jul 24, 2024 Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone ... Potential for the product to exhibit temperatures higher than specification w... Class II
Jun 3, 2024 Curved, super elastic cement delivery needle that passes through the cannula ... Expired Products distributed to customers Class II
Jun 3, 2024 This product is a single use sterile device that is used to direct the lesion... Expired Products distributed to customers Class II
Jun 3, 2024 The Non-Sterile Flyte hood covers the user s head and neck region and is inte... Expired Products distributed to customers Class II
Sep 13, 2023 Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposa... Expired product distributed Class II
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catal... An error was identified on the expiration date of the product label. The shel... Class II
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catal... An error was identified on the expiration date of the product label. The shel... Class II

View all 108 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.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.