Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software versio... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software versio... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version ... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version ... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software ve... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| 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 18, 2024 | SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis.... | Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however t... | Class II | Angiodynamics, Inc. |
| Jun 18, 2024 | ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377 | A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 18, 2024 | KIT PEDI CRANI LAMI, Pack Number DYNJ907372A | A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 18, 2024 | ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A | A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 18, 2024 | BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Co... | BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February ... | Class II | Embecta Corp. |
| Jun 18, 2024 | CRANIOTOMY PACK, Pack Number DYNJ46552O | A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 18, 2024 | SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis.... | Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however t... | Class II | Angiodynamics, Inc. |
| Jun 14, 2024 | L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x ... | Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains in... | Class II | Argon Medical Devices, Inc |
| Jun 11, 2024 | Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each ... | The protective pouches were identified to have been improperly labeled with UDI that is associate... | Class II | Medical Action Industries, Inc. 306 |
| Jun 7, 2024 | smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with B... | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... | Class I | Smiths Medical ASD Inc. |
| Jun 7, 2024 | smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BL... | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... | Class I | Smiths Medical ASD Inc. |
| Jun 7, 2024 | smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) ... | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... | Class I | Smiths Medical ASD Inc. |
| Jun 7, 2024 | OMTech Desktop Laser Engraver | Lack of redundant interlocks, missing required labels and certification labels as required by 21 ... | Class II | Rygel Advanced Machines d/b/a Omtech Laser |
| 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 |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONA... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHE... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRA... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number S... | Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... | Class II | Cardinal Health 200, LLC |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIA... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY ... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Cata... | Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... | Class II | Cardinal Health 200, LLC |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY ... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEO... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NE... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY T... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONA... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED ... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRAC... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TU... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD 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.