Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (S... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 22, 2024 | Surgical Tools and Cardiovascular Specialty marketing brochures, Reference nu... | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Di... | Class II | Baxter Healthcare Corporation |
| Feb 22, 2024 | Surgical Tools and Cardiovascular Specialty marketing brochures, Reference nu... | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Di... | Class II | Baxter Healthcare Corporation |
| Feb 22, 2024 | RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graf... | The stent-graft inside the delivery system was the incorrect size. | Class II | Bolton Medical Inc. |
| Feb 22, 2024 | Surgical Tools and Cardiovascular Specialty marketing brochures, Reference nu... | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Di... | Class II | Baxter Healthcare Corporation |
| Feb 21, 2024 | Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062... | InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential... | Class I | InfuTronix LLC |
| Feb 21, 2024 | Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulat... | InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential... | Class I | InfuTronix LLC |
| Feb 21, 2024 | Thermalon Heating Pad, Item Number 24002 | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Feb 21, 2024 | MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Feb 21, 2024 | Thermalon Eye Compress, Item Number 2434 | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Feb 21, 2024 | MediBeads Neck Wrap, Item Number 34320 | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Feb 21, 2024 | HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H. | It was discovered through a customer complaint that mislabeled product was distributed. Puritan d... | Class II | Puritan Medical Products Company, Llc |
| Feb 21, 2024 | Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 | Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detec... | Class II | Covidien |
| Feb 21, 2024 | Thermalon Neck Wrap, Item Number 24322 | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Feb 21, 2024 | ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. | The reason for the recall is the failure of calibration and quality controls due to a manufacturi... | Class II | Abbott Laboratories |
| Feb 21, 2024 | Thermalon Sinus Compress, Item Number 24332 | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Feb 21, 2024 | Thermalon Back Wrap, Item Number 24312 | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Feb 21, 2024 | Thermalon Sinus Compress (French), Item Number 24332F | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Feb 21, 2024 | SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pa... | Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be br... | Class II | Alcon Research, LLC |
| Feb 21, 2024 | Thermalon Stye Compress, Item Number 24352 | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Feb 20, 2024 | EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition dir... | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... | Class II | Boston Scientific Corporation |
| Feb 20, 2024 | EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition d... | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... | Class II | Boston Scientific Corporation |
| Feb 20, 2024 | Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilit... | Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Int... | Class II | Boston Scientific Corporation |
| Feb 20, 2024 | 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; ... | Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top fil... | Class II | 3M Company - Health Care Business |
| Feb 20, 2024 | Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A ... | Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly op... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 20, 2024 | EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutri... | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... | Class II | Boston Scientific Corporation |
| Feb 20, 2024 | EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nut... | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... | Class II | Boston Scientific Corporation |
| Feb 20, 2024 | Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0... | An investigation determined that delivery of the Obsidio embolic using the aliquot technique for ... | Class I | Boston Scientific Corporation |
| Feb 20, 2024 | HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) | Product was mislabeled as a Surgical Cap at its dispenser level. | Class III | O&M HALYARD, INC. |
| Feb 20, 2024 | EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutr... | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... | Class II | Boston Scientific Corporation |
| Feb 19, 2024 | HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Out... | Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated... | Class I | Thoratec Corp. |
| Feb 19, 2024 | Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 42... | Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the E... | Class II | ConvaTec, Inc |
| Feb 19, 2024 | HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed O... | Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated... | Class I | Thoratec Corp. |
| Feb 17, 2024 | Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Si... | A deterioration of the cutting knife, including overheating and burning, can contribute to tip br... | Class II | Olympus Corporation of the Americas |
| Feb 17, 2024 | Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Us... | A deterioration of the cutting knife, including overheating and burning, can contribute to tip br... | Class II | Olympus Corporation of the Americas |
| Feb 16, 2024 | Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of ... | Low concentration of sodium pyruvate in the wash could compromise gamete development | Class II | CooperSurgical, Inc. |
| Feb 16, 2024 | Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of s... | Low concentration of sodium pyruvate in the wash could compromise gamete development | Class II | CooperSurgical, Inc. |
| Feb 16, 2024 | Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090;... | There is a potential for sterile package breach. | Class II | Medtronic Inc. |
| Feb 16, 2024 | Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of ... | Low concentration of sodium pyruvate in the wash could compromise gamete development | Class II | CooperSurgical, Inc. |
| Feb 16, 2024 | CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOT... | Due to a manufacturing issue, device under process validation phase were inadvertently mixed into... | Class II | Biosense Webster, Inc. |
| Feb 16, 2024 | Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C | Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or c... | Class II | Medivance Inc. |
| Feb 15, 2024 | Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, M... | Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Co... | Class II | Augustine Temperature Management, LLC |
| Feb 15, 2024 | Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, | Their is a potential that Oximeter may automatically power off and on resulting in loss of monit... | Class II | Masimo Corporation |
| Feb 15, 2024 | Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, M... | Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Co... | Class II | Augustine Temperature Management, LLC |
| Feb 15, 2024 | DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX syst... | If the DIVA touch display generates touch inputs without user interaction, due to possibility of ... | Class II | Philips North America Llc |
| Feb 15, 2024 | Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, | Their is a potential that Oximeter may automatically power off and on resulting in loss of monit... | Class II | Masimo Corporation |
| Feb 15, 2024 | Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, | Their is a potential that Oximeter may automatically power off and on resulting in loss of monit... | Class II | Masimo Corporation |
| Feb 15, 2024 | Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial ... | Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperativ... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Feb 15, 2024 | Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, | Their is a potential that Oximeter may automatically power off and on resulting in loss of monit... | Class II | Masimo Corporation |
| Feb 15, 2024 | Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit | Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower ... | Class II | Bio-Rad Laboratories |
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.