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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.