Browse Device Recalls

5,540 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,540 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 5,540 FDA device recalls.

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DateProductReasonClassFirm
Jun 15, 2026 Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... Class II TISSIUM SA
Jun 11, 2026 Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU D... Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD Pu... Class II Medline Industries, LP
Jun 11, 2026 Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART M... Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD Pu... Class II Medline Industries, LP
Jun 11, 2026 FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablat... Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAP... Class II Boston Scientific Corporation
Jun 11, 2026 Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline K... Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD Pu... Class II Medline Industries, LP
Jun 11, 2026 Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit... Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD Pu... Class II Medline Industries, LP
Jun 11, 2026 FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutan... Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAP... Class II Boston Scientific Corporation
Jun 11, 2026 FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 6... Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAP... Class II Boston Scientific Corporation
Jun 10, 2026 Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma... Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... Class II Orthofix U.S. LLC
Jun 10, 2026 Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral... Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... Class II Orthofix U.S. LLC
Jun 10, 2026 Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral ... Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... Class II Orthofix U.S. LLC
Jun 10, 2026 Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilatera... Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... Class II Orthofix U.S. LLC
Jun 8, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Lami... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II Windstone Medical Packaging, Inc.
Jun 8, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT ... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II Windstone Medical Packaging, Inc.
Jun 8, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neur... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II Windstone Medical Packaging, Inc.
Jun 8, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT ... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II Windstone Medical Packaging, Inc.
Jun 8, 2026 MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline ... The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochl... Class I Medline Industries, LP
Jun 8, 2026 Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027... Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implan... Class II Micro Therapeutics, Inc.
Jun 8, 2026 Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027... Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implan... Class II Micro Therapeutics, Inc.
Jun 8, 2026 MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Med... The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochl... Class I Medline Industries, LP
Jun 5, 2026 MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU D... Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenie... Class I Medline Industries, LP
Jun 5, 2026 MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835;... Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenie... Class I Medline Industries, LP
Jun 5, 2026 Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the fo... Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device c... Class II Philips North America Llc
Jun 4, 2026 MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Numb... Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. mar... Class II BD SWITZERLAND SARL
May 22, 2026 GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible,... 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm dia... Class II W L Gore & Associates, Inc.
May 22, 2026 GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible,... 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm dia... Class II W L Gore & Associates, Inc.
May 19, 2026 American Contract Systems medical procedure kits and trays labeled as: 1) ... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II American Contract Systems Inc
May 19, 2026 American Contract Systems medical procedure kits and trays labeled as: 1) ... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II American Contract Systems Inc
May 19, 2026 TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400. Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in pa... Class II Howmedica Osteonics Corp.
May 19, 2026 TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in pa... Class II Howmedica Osteonics Corp.
May 14, 2026 Automated Impella Controller (AIC), for use with left heart support blood pum... Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction wi... Class I Abiomed, Inc.
May 13, 2026 Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA... Due to 11 volt Backup Battery failures. Class II Thoratec LLC
May 13, 2026 Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Sti... A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... Class II Medtronic Neuromodulation
May 13, 2026 Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Sti... A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... Class II Medtronic Neuromodulation
May 11, 2026 Power Over Fiber Base Module Device not certified - no laser product report was filed with CDRH prior to distribution. Produc... Class II Terex Utilities
May 11, 2026 Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory ... Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf ... Class II Inspire Medical Systems Inc.
May 11, 2026 Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation ... Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf ... Class II Inspire Medical Systems Inc.
May 11, 2026 NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and P... Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient l... Class II In2bones USA, LLC
May 7, 2026 Bicarby Dialysate; Model number: RFP-400-G; There is an error in the labeling of the GTIN on the product. When scanned; however, the case lab... Class II Fresenius Medical Care Holdings, Inc.
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT,... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline ... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Num... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Num... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline ... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SK... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot C... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Nu... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Num... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP

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.