Browse Device Recalls

3,133 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,133 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 3,133 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jun 29, 2022	Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF	Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains...	Class II	Trinity Sterile, Inc.
Jun 29, 2022	CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to intro...	Outside packaging for a device indicated for introducing cardiovascular catheters into the heart,...	Class II	Biosense Webster, Inc.
Jun 29, 2022	Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF	Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains...	Class II	Trinity Sterile, Inc.
Jun 29, 2022	Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5...	Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains...	Class II	Trinity Sterile, Inc.
Jun 29, 2022	Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708	Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains...	Class II	Trinity Sterile, Inc.
Jun 24, 2022	Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wi...	Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" ...	Class II	Medtronic Inc
Jun 22, 2022	(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in....	The product falls apart during handling after removal from its primary packaging.	Class II	ASO LLC
Jun 2, 2022	YelloPort Elite Universal Seal. For use in laparoscopic procedures.	There is the potential that YelloPort Elite Universal Seals packaging may contain small holes whi...	Class II	Surgical Innovations Ltd
Jun 1, 2022	NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3	The product was potentially exposed to below-recommended storage temperatures, which may cause le...	Class II	Fresenius Medical Care Holdings, Inc.
May 26, 2022	SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150...	Device model and size for affected lots of Laser Fibers may be mismatched between the product's c...	Class II	Olympus Corporation of the Americas
May 18, 2022	Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-28...	Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.	Class II	Paragon 28, Inc.
May 17, 2022	#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W...	Packaging error.	Class II	Baxter Healthcare Corporation
May 13, 2022	RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MIC...	The outer package is mislabeled and the package contains a different IOL strength.	Class II	Rayner Intraocular Lenses Ltd
Mar 23, 2022	Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO...	Packaging for Balloon Catheters may be damaged resulting in loss of sterility.	Class II	Medtronic Vascular, Inc.
Mar 23, 2022	Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV0600800...	Packaging for Balloon Catheters may be damaged resulting in loss of sterility.	Class II	Medtronic Vascular, Inc.
Mar 21, 2022	Prevantics swabs and/or swabsticks contained inside the following Aligned Med...	Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional D...	Class II	Windstone Medical Packaging, Inc.
Mar 18, 2022	Convenience kits containing regard IV Start Kits: (1) regard Clinical Pack...	A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the ...	Class II	ROi CPS LLC
Mar 18, 2022	Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl...	Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Hea...	Class II	Clinician's Choice Dental Products Inc.
Mar 18, 2022	Convenience kits containing regard IV Start Kits: regard Clinical Packaging ...	A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the ...	Class II	ROi CPS LLC
Mar 18, 2022	Convenience kits containing regard IV Start Kits: (1) regard Clinical Pack...	A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the ...	Class II	ROi CPS LLC
Feb 24, 2022	Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Steri...	Surgical knives may contain incorrect description printed on handles. Specifically, some surgical...	Class II	International Science & Technology, LP, DBA Dia...
Feb 14, 2022	BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [It...	Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s...	Class II	Biomet, Inc.
Feb 14, 2022	BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DV...	Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s...	Class II	Biomet, Inc.
Feb 14, 2022	BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [It...	Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s...	Class II	Biomet, Inc.
Feb 14, 2022	BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 85620400...	Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s...	Class II	Biomet, Inc.
Feb 7, 2022	The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providi...	Update to instructions for use regarding the cleaning and disinfection process for the reusable p...	Class II	Philips North America, LLC
Feb 3, 2022	Cardiovascular Procedure Kit catalog # 76645 & 73806	Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.	Class II	Terumo Cardiovascular Systems Corp
Jan 28, 2022	Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S	One lot of product was distributed in unsealed packaging	Class II	Brasseler USA, Medical L.L.C.
Jan 14, 2022	HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 6...	Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 ...	Class II	Maquet Cardiovascular, LLC
Dec 29, 2021	MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032	Inside the packaging of one reported item a non-conforming product was found. Contrary to the des...	Class II	Stryker Leibinger GmbH & Co. KG
Dec 29, 2021	YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR ...	The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Ind...	Class II	Young Dental Mfg Co I LLC
Dec 22, 2021	8mm FlexDex Needle Driver, Product Code FD-335 ND	The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon ins...	Class II	FlexDex Inc.
Dec 13, 2021	RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for ...	Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk o...	Class II	Collagen Matrix, Inc.
Dec 13, 2021	DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0...	Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk o...	Class II	Collagen Matrix, Inc.
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 3, 2021	Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.	The incorrect product is contained in the packaging.	Class II	Wright Medical Technology Inc
Dec 3, 2021	Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7m...	Incorrect product is contained in the packaging.	Class II	Wright Medical Technology, Inc.
Dec 3, 2021	Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.	The incorrect product is contained in the packaging.	Class II	Wright Medical Technology Inc
Dec 1, 2021	Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 dis...	The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the ...	Class II	CELLTRION USA INC
Nov 17, 2021	Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to...	Kit packaging may have small holes compromising product sterility	Class II	Beaver Visitec International, Inc.
Nov 17, 2021	Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid i...	Kit packaging may have small holes compromising product sterility	Class II	Beaver Visitec International, Inc.
Nov 17, 2021	Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in c...	Kit packaging may have small holes compromising product sterility	Class II	Beaver Visitec International, Inc.

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.