Browse Device Recalls

353 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 353 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 353 FDA device recalls.

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DateProductReasonClassFirm
Feb 18, 2026 Cub Pediatric Crib, Model FL19H Cribs sold in the USA are missing two access door warning labels. Class II Stryker Medical Division of Stryker Corporation
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 result of the magnet... Class II Stryker Corporation
Oct 31, 2025 NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve... Tape used to secure components within packaging contains latex, despite products being labeled as... Class II Stryker Corporation
Oct 31, 2025 Stryker MV3 bariatric bed, Part Number 5900000001 Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because som... Class II Stryker Medical Division of Stryker Corporation
Oct 31, 2025 Stryker Arise 1000EX mattress, Part Number 2236000000 Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because som... Class II Stryker Medical Division of Stryker Corporation
Oct 31, 2025 NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; ... Tape used to secure components within packaging contains latex, despite products being labeled as... Class II Stryker Corporation
Oct 31, 2025 NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's... Tape used to secure components within packaging contains latex, despite products being labeled as... Class II Stryker Corporation
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 during the procedure,... Class II Stryker Corporation
Jun 18, 2025 Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator withou... Due to complaints their is the potential that irrigation solution may leaked into the handpiece ... Class II Stryker Corporation
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 into the handpiece ... Class II Stryker Corporation
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 the seal area of the... Class II Stryker Corporation
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 the seal area of the... Class II Stryker Corporation
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 the seal area of the... Class II Stryker Corporation
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 the seal area of the... Class II Stryker Corporation
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 the seal area of the... Class II Stryker Corporation
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 the seal area of the... Class II Stryker Corporation
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 the seal area of the... Class II Stryker Corporation
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 the seal area of the... Class II Stryker Corporation
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 the seal area of the... Class II Stryker Corporation
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 the seal area of the... Class II Stryker Corporation
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 the seal area of the... Class II Stryker Corporation
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 the seal area of the... Class II Stryker Corporation
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 the seal area of the... Class II Stryker Corporation
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 the seal area of the... Class II Stryker Corporation
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 broken pullwire rema... Class II Stryker Corporation
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 specifications, preven... Class II Stryker Corporation
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 specifications, preven... Class II Stryker Corporation
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 properly tightened, impacti... Class II Stryker Corporation
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 plugged into a power s... Class II Stryker Corporation
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 plugged into a power s... Class II Stryker Corporation
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 plugged into a power s... Class II Stryker Corporation
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 plugged into a power s... Class II Stryker Corporation
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 plugged into a power s... Class II Stryker Corporation
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 plugged into a power s... Class II Stryker Corporation
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 inflammation may occur from e... Class II Stryker Corporation
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 where the bur shank m... Class II Stryker Corporation
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 where the bur shank m... Class II Stryker Corporation
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 where the bur shank m... Class II Stryker Corporation
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 where the bur shank m... Class II Stryker Corporation
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 where the bur shank m... Class II Stryker Corporation
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 where the bur shank m... Class II Stryker Corporation
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 where the bur shank m... Class II Stryker Corporation
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 where the bur shank m... Class II Stryker Corporation
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 where the bur shank m... Class II Stryker Corporation
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 where the bur shank m... Class II Stryker Corporation
Jun 3, 2024 Curved, super elastic cement delivery needle that passes through the cannula ... Expired Products distributed to customers Class II Stryker Corporation
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 Stryker Corporation
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 Stryker Corporation
Sep 13, 2023 Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposa... Expired product distributed Class II Stryker Corporation
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 shelf life for the produ... Class II Stryker Corporation

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.