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Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

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DateProductReasonClassFirm
Dec 8, 2017 ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARC... There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th... Class II Abbott Laboratories, Inc
Dec 8, 2017 Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revisi... Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. ... Class II Zimmer Biomet, Inc.
Dec 8, 2017 ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARC... There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th... Class II Abbott Laboratories, Inc
Dec 8, 2017 CARESCAPE R860 ventilators with software version 10SP05 Product Usage: Th... Potential for the display processor to experience an unexpected failure. Class II Datex-Ohmeda, Inc.
Dec 8, 2017 Widefield OCT software feature for the Spectralis HRA+OCT and variants FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefiel... Class II Heidelberg Engineering
Dec 7, 2017 PROPONENT MRI Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ESSENTIO MRI DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ALTRUA 2 DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 PROPONENT VDD SL Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 VISIONIST X4 CRT-P Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ESSENTIO EL DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 VALITUDE X4 CRT-P Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ACCOLADE EL DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ESSENTIO MRI EL DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ESSENTIO MRI SR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ALTRUA 2 SR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887... One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated scr... Class II Zimmer Biomet, Inc.
Dec 7, 2017 ESSENTIO SR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on... Some of the cards show occasional shorter clot times than the expected variation resulting in a p... Class II Helena Laboratories, Corp.
Dec 7, 2017 ACCOLADE MRI SR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ACCOLADE MRI DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 PROPONENT EL DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 VALITUDE CRT-P Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 PROPONENT DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ACCOLADE MRI EL DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ALTRUA 2 EL DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ESSENTIO DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 VISIONIST CRT-P Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ACCOLADE SR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ACCOLADE DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 PROPONENT SR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 6, 2017 Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF F... Medtronic has discovered the directional arrow at the proximal end of the instrument may not corr... Class II Medtronic Sofamor Danek USA Inc
Dec 6, 2017 Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended ... Product has been found with a missing Washer, Retaining Ring, and/or Stop Screw. Recalling firm w... Class II Reliance Medical Products Inc
Dec 6, 2017 Health Harmony Mobile application software Product Usage: Care Innovatio... It was discovered that in certain situations, including partial sessions and when taking adhoc me... Class II Intel-GE Care Innovations LLC
Dec 5, 2017 Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - ... An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one... Class II Ion Beam Applications S.A.
Dec 4, 2017 Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 0456014194... There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke m... Class II Konica Minolta Medical Imaging USA, Inc.
Dec 4, 2017 Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 0456014194... There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke m... Class II Konica Minolta Medical Imaging USA, Inc.
Dec 4, 2017 Ultra Renew Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation Class II Accord Media, LLC
Dec 4, 2017 Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM... Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kit... Class II Smiths Medical ASD Inc.
Dec 4, 2017 Truth Renew Plus Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation Class II Accord Media, LLC
Dec 4, 2017 Truth Renew Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation Class II Accord Media, LLC
Dec 4, 2017 Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461;... The Oncomine Dx Target Test may report erroneous results when used off-label for samples other th... Class II Life Technologies Corporation
Dec 4, 2017 LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e... Physio-Control is aware that some devices have had power-related failures as customers prepared t... Class I Physio-Control, Inc.
Dec 4, 2017 Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 0456014... There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke m... Class II Konica Minolta Medical Imaging USA, Inc.
Dec 4, 2017 Ultra Renew Plus Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation Class II Accord Media, LLC
Dec 4, 2017 CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following pr... A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, a... Class II Cellavision AB
Dec 4, 2017 iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iC... A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad pla... Class II Beckman Coulter Inc.
Dec 4, 2017 Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 0456014194... There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke m... Class II Konica Minolta Medical Imaging USA, Inc.
Dec 4, 2017 PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM... Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kit... Class II Smiths Medical ASD Inc.
Dec 2, 2017 Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software versi... Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusio... Class II Fresenius Vial Sa

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.