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 |
|---|---|---|---|---|
| Mar 12, 2024 | Achieva 1.5T Initial, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera 1.5T R11, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Achieva 1.5T Conversion, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera CV, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Achieva 3.0TX for PET, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera Achieva 1.5T Pulsar, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | GYROSCAN T5, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | MR 7700, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Enterprise 1.5T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Ingenia Elition X, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Ingenia Elition S, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIF... | Products have a lack of sterility assurance. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 12, 2024 | Ingenia 1.5T CX, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Achieva XR, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | GYROSCAN ACS-NT, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera 1.0T Omni/Stellar, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera 1.5T Achieva IT Nova, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera 1.5T Achieva Nova, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Namic FLUID DELIVERY SET, REF 91300040 | Products have a lack of sterility assurance. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 12, 2024 | Intera 1.5T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | GYROSCAN T5-NT, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Achieva 3.0T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera 1.5T Omni/Stellar, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Achieva 1.5T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Ingenia 1.5T S, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 11, 2024 | RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would... | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump... | Class II | Smith & Nephew Medical, Ltd. |
| Mar 11, 2024 | Ureteral dilator, REF RBD014 | A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facil... | Class II | Coloplast Manufacturing US, LLC |
| Mar 11, 2024 | RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would... | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump... | Class II | Smith & Nephew Medical, Ltd. |
| Mar 11, 2024 | HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to positi... | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction ... | Class II | Baxter Healthcare Corporation |
| Mar 11, 2024 | Identity Imprint PS Tibial Tray Size 4: Lot 540287 | Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed... | Class II | Conformis, Inc. |
| Mar 11, 2024 | OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the met... | System error messages may delay the ability to test patient samples and the need for frequent cal... | Class II | Advanced Instruments, LLC |
| Mar 9, 2024 | Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Gal... | Due to a misaligned calibration of the wired controller that may result in unintended motion of t... | Class II | Noah Medical |
| Mar 8, 2024 | STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: ... | Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions du... | Class II | Ethicon, Inc. |
| Mar 8, 2024 | Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used f... | Their is the potential for distal tip separation at the proximal marker band of the delivery cath... | Class I | ROUTE 92 MEDICAL INC |
| Mar 8, 2024 | Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. ... | Their is the potential for distal tip separation at the proximal marker band of the delivery cath... | Class I | ROUTE 92 MEDICAL INC |
| Mar 8, 2024 | Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, Ster... | Their is the potential for distal tip separation at the proximal marker band of the delivery cath... | Class I | ROUTE 92 MEDICAL INC |
| Mar 8, 2024 | Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO.... | Their is the potential for distal tip separation at the proximal marker band of the delivery cath... | Class I | ROUTE 92 MEDICAL INC |
| Mar 8, 2024 | Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for... | Their is the potential for distal tip separation at the proximal marker band of the delivery cath... | Class I | ROUTE 92 MEDICAL INC |
| Mar 7, 2024 | POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indica... | Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immedia... | Class II | Olympus Corporation of the Americas |
| Mar 7, 2024 | POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indica... | Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immedia... | Class II | Olympus Corporation of the Americas |
| Mar 7, 2024 | POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indica... | Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immedia... | Class II | Olympus Corporation of the Americas |
| Mar 7, 2024 | INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup | 54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 ... | Class II | Innomed, Inc. |
| Mar 7, 2024 | LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. | Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy ... | Class I | Fresenius Kabi USA, LLC |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 3... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | CryoValve SG Cryopreserved Pulmonary Human Heart Valve | The blood cultures performed as part of the organ donation process were positive for Staphylococc... | Class II | Artivion, Inc |
| Mar 6, 2024 | Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, 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.