Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 15, 2025 | IntelliVue Patient Monitor MX550. Model Number: 866066 | Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton venti... | Class II | Philips North America Llc |
| Jan 15, 2025 | IntelliBridge EC10 Module. Model Number: 865115 | Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton venti... | Class II | Philips North America Llc |
| Jan 15, 2025 | Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model... | Devices presented a condition in which the inner needle separated from the hub and produced a lon... | Class II | Hologic, Inc |
| Jan 14, 2025 | Infinity Central Station. Model Number: MS26800 The Infinity CentralStatio... | Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mo... | Class II | Draeger Medical Systems, Inc. |
| Jan 13, 2025 | Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | AlluraXperFD20/10 System Code: (1) 722029 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 ... | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | AlluraXperFD20/15 System Code: (1) 722058 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 5 M12 System Code: (1) 722227 (2) 722231 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD20/20 System Code: (1) 722038 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD10C System Code: (1) 722001 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura CV20 System Code: 722031 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 3 M12 System Code: (1) 722063 (2) 722221 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 10, 2025 | Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Ge... | Potential that the induction seal is not completely sealed to the device tube packaging. | Class II | Integra LifeSciences Corp. |
| Jan 10, 2025 | BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass,... | Automated dispensing device labeling is being updated to strengthen labeling around manual access... | Class II | CareFusion 303, Inc. |
| Jan 10, 2025 | . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP ... | Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin t... | Class II | Nobel Biocare |
| Jan 10, 2025 | DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected... | Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing t... | Class II | BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO.... |
| Jan 9, 2025 | CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacteria... | The machine side connector of the filter HME may be occluded by plastic which prevents proper air... | Class II | Kung Shin Plastics Co. Ltd. |
| Jan 9, 2025 | A820 myPTM Software Application associated with Medtronic SynchroMed Pump and... | Product complaints were received describing the A820 myPTM app taking longer than expected for pa... | Class II | Medtronic Neuromodulation |
| Jan 9, 2025 | Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER... | Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 9, 2025 | CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200... | The machine side connector of the filter HME may be occluded by plastic which prevents proper air... | Class II | Kung Shin Plastics Co. Ltd. |
| Jan 9, 2025 | Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, M... | Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 8, 2025 | The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the ... | Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Sp... | Class II | Hologic, Inc. |
| Jan 8, 2025 | stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating an... | Precision Thin blade attachments have a potential to be out of measurement specifications, preven... | Class II | Stryker Corporation |
| Jan 8, 2025 | (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS)... | Software issues could potentially result in: 1) delays in accessing dispensing software applicati... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR... | Labeling update to include a contraindication statement against the use of medicine cabinets in ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | 155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM... | Labeling update to include a contraindication statement against the use of medicine cabinets in ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | 139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2... | Labeling update to include a contraindication statement against the use of medicine cabinets in ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a ... | The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. T... | Class II | Ithera Medical Gmbh |
| Jan 8, 2025 | (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station ... | Labeling is insufficient regarding delays in access to medication. The firm is strengthening the ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating an... | Precision Thin blade attachments have a potential to be out of measurement specifications, preven... | Class II | Stryker Corporation |
| Jan 8, 2025 | 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 100... | Labeling update to include a contraindication statement against the use of medicine cabinets in ... | Class II | CareFusion 303, Inc. |
| Jan 6, 2025 | NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D ... | It was identified internally that two commingle events occurred where the metal support post with... | Class II | Zimmer, Inc. |
| Jan 6, 2025 | Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Ca... | Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omiss... | Class II | Sysmex America, Inc. |
| Jan 6, 2025 | NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F ... | It was identified internally that two commingle events occurred where the metal support post with... | Class II | Zimmer, Inc. |
| Jan 3, 2025 | Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer... | Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorr... | Class II | XTANT Medical Holdings, Inc |
| Jan 3, 2025 | Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenien... | Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 3, 2025 | Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/... | Their is a potential that implanted pulse generators may stop delivering therapy due to an intern... | Class II | LivaNova USA, Inc. |
| Jan 3, 2025 | Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000... | Their is a potential that implanted pulse generators may stop delivering therapy due to an intern... | Class II | LivaNova USA, Inc. |
| Jan 2, 2025 | Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI... | Disposable set may leak during priming from a female quick connector due to a crack in the female... | Class II | Belmont Instrument LLC |
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.