Browse Device Recalls

969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 969 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 969 FDA device recalls.

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Date	Product	Reason	Class	Firm
Dec 9, 2016	Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinSt...	Merge received reports of Merge Eye Station being unable to capture images of the eye as expected...	Class II	Merge Healthcare, Inc.
Nov 21, 2016	Prestige II	GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,...	Class II	GE Healthcare, LLC
Nov 21, 2016	SFX	GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,...	Class II	GE Healthcare, LLC
Nov 21, 2016	ADVANTX LCN+	GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,...	Class II	GE Healthcare, LLC
Nov 21, 2016	ADVANTX LCLP+	GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,...	Class II	GE Healthcare, LLC
Nov 21, 2016	Legacy	GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,...	Class II	GE Healthcare, LLC
Nov 21, 2016	Innova 2000	GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,...	Class II	GE Healthcare, LLC
Nov 21, 2016	Prestilix	GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,...	Class II	GE Healthcare, LLC
Nov 21, 2016	ADVANTX LCV+	GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,...	Class II	GE Healthcare, LLC
Nov 21, 2016	RFX	GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,...	Class II	GE Healthcare, LLC
Nov 21, 2016	Prestige SI	GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,...	Class II	GE Healthcare, LLC
Nov 21, 2016	ADVANTX LCA	GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,...	Class II	GE Healthcare, LLC
Nov 21, 2016	Precision 500D	GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,...	Class II	GE Healthcare, LLC
Nov 21, 2016	Prestige VH	GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,...	Class II	GE Healthcare, LLC
Nov 3, 2016	GE Healthcare, Avance, Avance CS2, Amingo.	GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and A...	Class II	GE Healthcare, LLC
Oct 20, 2016	Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a...	A product issues happens for RF projection images. If user measures on RF image, .cal (Calibratio...	Class II	Merge Healthcare, Inc.
Sep 23, 2016	OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Produc...	GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 6...	Class II	GE OEC Medical Systems, Inc
Sep 16, 2016	Brivo XR385, model 5215463, Digital Diagnostic Radiographic System	The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can i...	Class II	GE Healthcare, LLC
Aug 31, 2016	GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.	GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involv...	Class II	GE Healthcare, LLC
Aug 4, 2016	Infant Warmer System (IWS)	GE Healthcare has recently become aware of a potential safety issue related to loose screws in th...	Class II	GE Healthcare, LLC
Jul 14, 2016	Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30...	It was reported by a customer that RadSuite images are not appearing as readable images. Thi...	Class II	Merge Healthcare, Inc.
Jun 8, 2016	GE Healthcare, Discovery MR750w	GE Healthcare has recently become aware of a potential safety issue with the patient bore heating...	Class II	GE Healthcare, LLC
May 25, 2016	iConnect Access software. The firm name on the label is Merge Healthcare, Ha...	Software displayed incorrect prior reports in the viewport area, only when more than one prior st...	Class II	Merge Healthcare, Inc.
May 9, 2016	Optima 1.5T MR430s MR Scanner, a diagnostic imaging device	The gas venting may not occur properly. A site reported a magnet quenching with subsequent venti...	Class II	GE Healthcare, LLC
May 9, 2016	MSK 1.5T Extreme MR Scanner, a diagnostic imaging device	The gas venting may not occur properly. A site reported a magnet quenching with subsequent venti...	Class II	GE Healthcare, LLC
May 9, 2016	GE Revolution CT The system is intended for head, whole body, cardiac and ...	GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can res...	Class II	GE Healthcare, LLC
Apr 15, 2016	GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscop...	Potential non-recoverable loss of image acquisition. The affected Discovery systems may experie...	Class II	GE Medical Systems, LLC
Apr 15, 2016	Merge LIS software. The firm name on the label is Merge Healthcare. Merge...	There are potential issues with results reporting for certain run-based tests. Under certain con...	Class II	Merge Healthcare, Inc.
Apr 15, 2016	GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscop...	Potential non-recoverable loss of image acquisition. The affected Discovery systems may experie...	Class II	GE Medical Systems, LLC
Apr 13, 2016	Merge Cardio software. The firm name on the label is Merge Healthcare, Hartl...	Fetal patient report was automatically pulling prior measurement data for a prior fetus since the...	Class II	Merge Healthcare, Inc.
Apr 8, 2016	DR Systems Unity PACS software, now known as Merge Unity PACS	Reports were missing demographic header information when they were faxed to referring physicians.	Class II	Merge Healthcare, Inc.
Apr 8, 2016	DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usa...	The software is not adding the correct tomo image.	Class II	Merge Healthcare, Inc.
Apr 4, 2016	Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitor...	In some instances, the system will lock tabs within a study, even when a second user does not hav...	Class II	Merge Healthcare, Inc.
Apr 4, 2016	MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part ...	Under certain conditions, the cables used with the Hemo system during a patient procedure could s...	Class II	Merge Healthcare, Inc.
Apr 4, 2016	iConnect Enterprise Archive software.	The versions allow images to be stored without pixel data, resulting in the system not being able...	Class II	Merge Healthcare, Inc.
Apr 4, 2016	iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is ...	The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting i...	Class II	Merge Healthcare, Inc.
Apr 4, 2016	Merge Cardio software. The firm name on the label is Merge Healthcare, Hartla...	When taking measurements from images on the Cardio workstation or from the US cart, numbers are n...	Class II	Merge Healthcare, Inc.
Apr 4, 2016	MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger cli...	Under certain conditions, the cables used with the Hemo system during a patient procedure could s...	Class II	Merge Healthcare, Inc.
Apr 4, 2016	iConnect Enterprise Archive when used with RadSuite. The firm name on the la...	The software produced a number of "do not route" exceptions, which may result in potential pati...	Class II	Merge Healthcare, Inc.
Apr 4, 2016	Merge Eye Station and Merge Eye Care PACS.	During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may d...	Class II	Merge Healthcare, Inc.
Apr 4, 2016	Merge PACS software. The firm name on the label is Merge Healthcare.	Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol t...	Class II	Merge Healthcare, Inc.
Apr 4, 2016	Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Me...	System locks up which may result in potential patient injury or delay in diagnosis or treatment.	Class II	Merge Healthcare, Inc.
Apr 4, 2016	Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan...	Potential exists for an incorrect patient image being displayed which could result in the delay i...	Class II	Merge Healthcare, Inc.
Apr 4, 2016	Merge Cardio software using EchoIMS. The firm name on the label is Merge Hea...	A situation can occur allowing two physicians to access the same study report in EchoIMS when lau...	Class II	Merge Healthcare, Inc.
Apr 4, 2016	iConnect Enterprise Archive (ICEA) software. The firm name on the labeling i...	An error message can occur resulting in the prior studies being unavailable for viewing.	Class II	Merge Healthcare, Inc.
Apr 4, 2016	SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-0001...	Under certain conditions, the cables used with the Hemo system during a patient procedure could s...	Class II	Merge Healthcare, Inc.
Apr 4, 2016	Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Pr...	Under certain conditions, the cables used with the Hemo system during a patient procedure could s...	Class II	Merge Healthcare, Inc.
Apr 4, 2016	Merge Cardio software.	Cardio study list does not show STAT studies without refreshing.	Class II	Merge Healthcare, Inc.
Apr 4, 2016	Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hart...	Use of the software may show an incorrect value to the user when viewing the Fractional Flow Rese...	Class II	Merge Healthcare, Inc.
Apr 4, 2016	Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS,...	The system will completely stop allowing the downloading or acquisition of new images due to inco...	Class II	Merge Healthcare, 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.