Class IIIOngoingZ-0893-2026
Orthofix U.S. LLC recalls Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System M…
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCTXDec 17, 2025
Class III recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 37–48 of 125 recalls
Class IIIOngoingZ-0892-2026
Orthofix U.S. LLC recalls Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Cat…
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCTXDec 17, 2025
Class IIIOngoingZ-0891-2026
Orthofix U.S. LLC recalls Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer S…
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCTXDec 17, 2025
Class IIIOngoingZ-0538-2026
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC recalls OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials design…
A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16.…
POLYMEDCO, INC. / POLY…NYNov 26, 2025
Class IIIOngoingZ-0500-2026
Accriva Diagnostics, Inc. recalls VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 Th…
Due to an device without a premarket clearance being incorrectly package and distributed.
Accriva Diagnostics, I…CANov 19, 2025
Class IIIOngoingZ-0226-2026
Home Health US, Incorporated recalls One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854…
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Home Health US, Incorp…FLOct 29, 2025
Class IIIOngoingZ-2517-2025
Flosonics Medical (R/A 1929803 ONTARIO CORP.) recalls FloPatch FP120
Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.
Flosonics Medical (R/A…Sep 10, 2025
Class IIIOngoingZ-2451-2025
Bausch & Lomb Surgical, Inc. recalls Akreos
An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acui…
Bausch & Lomb Surgical…FLSep 3, 2025
Class IIIOngoingZ-2414-2025
Philips Ultrasound, Inc recalls XL14-3 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, In…PASep 3, 2025
Class IIIOngoingZ-2413-2025
Philips Ultrasound, Inc recalls X8-2t Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, In…PASep 3, 2025
Class IIIOngoingZ-2412-2025
Philips Ultrasound, Inc recalls X7-2t Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, In…PASep 3, 2025
Class IIIOngoingZ-2411-2025
Philips Ultrasound, Inc recalls X7-2 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, In…PASep 3, 2025