Browse Device Recalls

1,025 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,025 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 1,025 FDA device recalls — Class III.

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DateProductReasonClassFirm
Mar 25, 2026 Heraeus, PALAMIX duo. Material Number: 66057897. Based on long-term stability testing, it was determined that in units older than 1.5 years (17 mo... Class III Heraeus Medical GmbH (Dental Division)
Mar 25, 2026 Heraeus, PALAMIX uno. Material Number: 66057893. Based on long-term stability testing, it was determined that in units older than 1.5 years (17 mo... Class III Heraeus Medical GmbH (Dental Division)
Feb 6, 2026 Battery Charging Station; Model: 0998-00-0802; The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP ... Class III Datascope Corp.
Jan 6, 2026 WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM The mix up of the impression caps provided in the package. The provided impression caps are magen... Class III Straumann USA LLC
Nov 18, 2025 HemosIL SynthAFax. Partial Thromboplastin Time Tests. Recalled lots were manufactured with double the amount of preservative concentration. Class III Instrumentation Laboratory
Nov 3, 2025 Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Nov 3, 2025 Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System ... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Nov 3, 2025 Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion Sys... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Nov 3, 2025 Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System M... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Nov 3, 2025 Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PT... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Nov 3, 2025 Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti ... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Oct 23, 2025 Cardiosave Hybrid The IFU addendum updates the Vibration and Shock Table to reference the correct standards. Class III Datascope Corp.
Oct 23, 2025 Cardiosave Rescue The IFU addendum updates the Vibration and Shock Table to reference the correct standards. Class III Datascope Corp.
Oct 21, 2025 VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 1071123415... Due to an device without a premarket clearance being incorrectly package and distributed. Class III Accriva Diagnostics, Inc.
Oct 6, 2025 OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materi... A labeling error was identified on the affected product. The expiration date on the kit box label... Class III POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC P...
Sep 5, 2025 Philips Mini Multi TEE Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips S5-2 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips S4-1 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips X3-1 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips OMNI II TEE Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips L17-5 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips OMNI III TEE Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips 3D6-2 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips X7-2 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips L12-5 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips C9-4 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Aug 13, 2025 Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 36... The device does not bear a unique device identifier. Class III Penner Patient Care, Inc.
Aug 13, 2025 Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 56... The device does not bear a unique device identifier. Class III Penner Patient Care, Inc.
Aug 13, 2025 Penner Pacific Bathing Spa, Model Numbers 360020-1EP The device does not bear a unique device identifier. Class III Penner Patient Care, Inc.
Aug 13, 2025 Penner Pacific Bathing Spa, Model Numbers 860010-1L The device does not bear a unique device identifier. Class III Penner Patient Care, Inc.
Aug 13, 2025 Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS,... The device does not bear a unique device identifier. Class III Penner Patient Care, Inc.
Aug 13, 2025 Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X The device does not bear a unique device identifier. Class III Penner Patient Care, Inc.
Aug 13, 2025 Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2 The device does not bear a unique device identifier. Class III Penner Patient Care, Inc.
Aug 13, 2025 Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 36... The device does not bear a unique device identifier. Class III Penner Patient Care, Inc.
Aug 13, 2025 Penner Pacific Bathing Spa, Model Numbers 360020-1P The device does not bear a unique device identifier. Class III Penner Patient Care, Inc.
Aug 13, 2025 Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1 The device does not bear a unique device identifier. Class III Penner Patient Care, Inc.
Aug 7, 2025 FloPatch FP120, REF: FP120-FOT01-005 Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-0... Class III Flosonics Medical (R/A 1929803 ONTARIO CORP.)
Jul 25, 2025 One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 0694... Due to incorrect/lack of Unique Device Identifier (UDI) codes. Class III Home Health US, Incorporated
Jul 10, 2025 Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MI... Reports of delayed access to medication in automated dispensing cabinets because of the override/... Class III CareFusion 303, Inc.
Jul 3, 2025 X7-2t Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 X6-1 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 C9-3v Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 L11-3 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 L12-4 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 L12-5 50 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 L8-4 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 OMNI II TEE Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 BP10-5ec Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 C9-4 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 X8-2t Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, 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.