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
Oct 1, 2024	MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLIN...	Due to defects on primary packaging pouch that compromise the device's ability to maintain a ster...	Class II	Advanced Medical Solutions Ltd.
Sep 24, 2024	Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixtu...	Due to packaging damage from heat exposure during shipping/transportation that may result in a br...	Class II	West Pharmaceutical Services AZ, Inc.
Sep 23, 2024	KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40),...	The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek s...	Class II	Pro-Dex Inc
Sep 17, 2024	Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing L...	The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer pack...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Sep 17, 2024	MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00-...	There is discrepant labeling on the inner and outer packaging of the device.	Class II	Datascope Corp.
Sep 3, 2024	(1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with ...	Product has been identified as having holes in the packaging.	Class II	MEDLINE INDUSTRIES, LP - Northfield
Aug 30, 2024	The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable st...	Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instruct...	Class II	Stryker Neurovascular
Aug 29, 2024	Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrum...	Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobact...	Class II	Microcare Medical
Aug 20, 2024	Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use i...	Baxter Healthcare Corporation has received increased customer reports of particulate matter in th...	Class I	Baxter Healthcare Corporation
Aug 20, 2024	Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a...	Baxter Healthcare Corporation has received increased customer reports of particulate matter in th...	Class I	Baxter Healthcare Corporation
Aug 20, 2024	Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a ...	Baxter Healthcare Corporation has received increased customer reports of particulate matter in th...	Class I	Baxter Healthcare Corporation
Aug 20, 2024	Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a phar...	Baxter Healthcare Corporation has received increased customer reports of particulate matter in th...	Class I	Baxter Healthcare Corporation
Aug 16, 2024	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health...	Due to convenience kits containing a kit component that is under a recall action for improper use.	Class II	Windstone Medical Packaging, Inc.
Aug 16, 2024	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Sa...	Due to convenience kits containing a kit component that is under a recall action for improper use.	Class II	Windstone Medical Packaging, Inc.
Aug 16, 2024	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Sa...	Due to convenience kits containing a kit component that is under a recall action for improper use.	Class II	Windstone Medical Packaging, Inc.
Aug 16, 2024	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health S...	Due to convenience kits containing a kit component that is under a recall action for improper use.	Class II	Windstone Medical Packaging, Inc.
Aug 16, 2024	Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Sal...	Due to convenience kits containing a kit component that is under a recall action for improper use.	Class II	Windstone Medical Packaging, Inc.
Aug 12, 2024	ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation ...	Product packaging process may result in an improper or incomplete seal of the outer foil pouch su...	Class II	Smith & Nephew Inc.
Aug 12, 2024	ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixatio...	Product packaging process may result in an improper or incomplete seal of the outer foil pouch su...	Class II	Smith & Nephew Inc.
Aug 8, 2024	Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use i...	Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck ...	Class II	Zimmer GmbH
Aug 8, 2024	Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in to...	Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck ...	Class II	Zimmer GmbH
Aug 2, 2024	BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN161...	Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result...	Class II	Bard Peripheral Vascular Inc
Jul 26, 2024	Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray w...	Reports have been received regarding open seals on the packaging.	Class II	ARROW INTERNATIONAL Inc.
Jul 24, 2024	regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Numbe...	Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Med...	Class II	ROi CPS LLC
Jul 23, 2024	VariSoft Infusion Set, Single Use.	Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) brand...	Class II	Unomedical A/S
Jul 18, 2024	smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; ...	Uncertainty in the seal integrity of the sterile packaging.	Class II	Smiths Medical ASD Inc.
Jul 18, 2024	smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) RE...	Uncertainty in the seal integrity of the sterile packaging.	Class II	Smiths Medical ASD Inc.
Jul 18, 2024	smiths medical portex, Y' PIECE 15MM, REF 100/276/000	Uncertainty in the seal integrity of the sterile packaging.	Class II	Smiths Medical ASD Inc.
Jul 18, 2024	smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY ...	Uncertainty in the seal integrity of the sterile packaging.	Class II	Smiths Medical ASD Inc.
Jul 18, 2024	smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100...	Uncertainty in the seal integrity of the sterile packaging.	Class II	Smiths Medical ASD Inc.
Jul 9, 2024	DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener	Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires d...	Class II	Smith & Nephew, Inc.
Jul 9, 2024	DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener	Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires d...	Class II	Smith & Nephew, Inc.
Jul 2, 2024	BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-0...	Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier,...	Class II	Argon Medical Devices, Inc
Jul 1, 2024	Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the followi...	Due to packaging defects, sterility assurance and heparin activity may be compromised.	Class II	W L Gore & Associates, Inc.
Jul 1, 2024	The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ...	Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach	Class II	Olympus Corporation of the Americas
Jul 1, 2024	Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the followi...	Due to packaging defects, sterility assurance and heparin activity may be compromised.	Class II	W L Gore & Associates, Inc.
Jul 1, 2024	The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ...	Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach	Class II	Olympus Corporation of the Americas
Jul 1, 2024	The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ...	Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach	Class II	Olympus Corporation of the Americas
Jun 19, 2024	UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in p...	Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia...	Class II	Howmedica Osteonics Corp.
Jun 19, 2024	UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in p...	Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia...	Class II	Howmedica Osteonics Corp.
Jun 19, 2024	UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in p...	Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia...	Class II	Howmedica Osteonics Corp.
Jun 17, 2024	Regard Kit containing the Microtek decanter	Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.	Class II	ROi CPS LLC
Jun 11, 2024	SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963	Some foil pouches were found torn open, impacting the sterile barrier which was traced to a speci...	Class II	Ethicon Sarl, a Johnson & Johnson Company
Jun 11, 2024	SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961	Some foil pouches were found torn open, impacting the sterile barrier which was traced to a speci...	Class II	Ethicon Sarl, a Johnson & Johnson Company
Jun 3, 2024	Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a ...	During sterile barrier testing performed on the decanter product line, the samples were identifie...	Class II	Microtek Medical Inc.
Jun 3, 2024	C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine wit...	During sterile barrier testing performed on the decanter product line, the samples were identifie...	Class II	Microtek Medical Inc.
Jun 3, 2024	Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a ...	During sterile barrier testing performed on the decanter product line, the samples were identifie...	Class II	Microtek Medical Inc.
Jun 3, 2024	Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a po...	During sterile barrier testing performed on the decanter product line, the samples were identifie...	Class II	Microtek Medical Inc.
Jun 3, 2024	Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a ...	During sterile barrier testing performed on the decanter product line, the samples were identifie...	Class II	Microtek Medical Inc.
May 31, 2024	REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, si...	Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourn...	Class II	Stryker Sustainability Solutions

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.