Browse Device Recalls

35,653 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,653 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 35,653 FDA device recalls, Class II.

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DateProductReasonClassFirm
Jan 16, 2025 Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning Sys... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 15, 2025 DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C... The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer con... Class II DeRoyal Industries Inc
Jan 15, 2025 MOSAIQ Oncology Information System Image offsets calculated by oncology Information System software may be incorrect for Linear A... Class II Elekta, Inc.
Jan 15, 2025 IntelliVue Patient Monitor MX500. Model Number: 866064 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 ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135. Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the... Class II TERRAGENE S.A.
Jan 15, 2025 IntelliVue Patient Monitor MX400. Model Number: 866060 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 IntelliVue Patient Monitor MX450. Model Number: 866062 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 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

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.