Browse Device Recalls

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

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Date	Product	Reason	Class	Firm
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	Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvan...	Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720...	Class II	Smiths Medical ASD Inc.
Nov 21, 2016	GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indic...	Endotoxin values from testing of retains slightly exceeded the established specification.	Class II	Tepha Incorporated
Nov 21, 2016	Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 5...	Device could cause a patient overpressure situation without any visual or auditory indication or ...	Class II	Northgate Technologies, Inc.
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	Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not fo...	Firm became aware that professional samples of Ceramax are not meeting stability standards set fo...	Class II	Oculus Innovative Sciences, Inc.
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	CryoPatch SG Pulmonary Hemi-Artery Patch	The device is recalled due to donor ineligibility of released human tissue. The firm received inf...	Class II	CryoLife, Inc.
Nov 21, 2016	Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738...	Software error; Carestream Health Inc, received a complaint stating that when a user accidentally...	Class II	Carestream Health Inc
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	Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. ...	Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance man...	Class II	INO Therapeutics (dba Ikaria)
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 20, 2016	Shimadzu X-ray TV System, Catalog No. SONIALVISION G4	Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of...	Class II	Shimadzu Medical Systems
Nov 20, 2016	Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION saf...	Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possib...	Class II	Shimadzu Medical Systems
Nov 18, 2016	ddR Formula B X-ray System, Model ddR Formula B X-ray system used for ima...	Potential for bucky (the part that holds the grid and is moveable to position the patient) moving...	Class II	Swissray Medical
Nov 18, 2016	AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651...	Incorrect priming volume is printed on the device package.	Class II	Vygon MFG, Inc., dba/ Churchill Medical Systems...
Nov 18, 2016	FV-RF (Clinix RF Plus) Product Usage: A Stationary X-ray System, a device...	There's a potential for liquid penetration into the back side of the front control panel of the X...	Class II	Philips Medical Systems (Cleveland) Inc
Nov 18, 2016	IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay...	Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA a...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 18, 2016	OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical...	Labeled as a 48mm Cortical Screw but measuring at 50mm	Class III	OrthoPediatrics Corp
Nov 18, 2016	Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates ...	Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a...	Class II	Ohmeda Medical
Nov 18, 2016	WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medica...	Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.	Class II	Teleflex Medical
Nov 18, 2016	Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an i...	Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a...	Class II	Ohmeda Medical
Nov 18, 2016	IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a ...	Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a...	Class II	Ohmeda Medical
Nov 18, 2016	IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Cat...	Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays ...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 18, 2016	Giraffe Incubator The Giraffe Incubator is an infant incubator. Incubators p...	Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a...	Class II	Ohmeda Medical
Nov 18, 2016	Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT...	Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a...	Class II	Ohmeda Medical
Nov 18, 2016	Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination...	Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a...	Class II	Ohmeda Medical
Nov 18, 2016	Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer-...	Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a...	Class II	Ohmeda Medical
Nov 18, 2016	Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmer...	Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a...	Class II	Ohmeda Medical
Nov 18, 2016	CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a cont...	Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a...	Class II	Ohmeda Medical
Nov 18, 2016	Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is ...	Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a...	Class II	Ohmeda Medical
Nov 18, 2016	Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant...	Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a...	Class II	Ohmeda Medical
Nov 17, 2016	PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Ortho...	The recall is being initiated because all broach handles in the affected lot had the same non-con...	Class II	MicroPort Orthopedics Inc.
Nov 17, 2016	Monaco TRP System The Monaco system is used to make treatment plans for pati...	Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of ...	Class II	Elekta, Inc.
Nov 17, 2016	SmartSite Add-On Bag Access Device, Model No. 10013365	CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leaka...	Class II	CareFusion 303, Inc.
Nov 17, 2016	UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT ...	There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lo...	Class II	Ultradent Products, Inc.
Nov 16, 2016	Weck Facial Closure Systems have application in laparoscopic procedures for ...	The devices wings may become partially detached from the EFx Shield during use.	Class II	Teleflex Medical
Nov 16, 2016	Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion...	Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusio...	Class II	Medtronic Inc
Nov 16, 2016	DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum	A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrat...	Class III	PerkinElmer Health Sciences, Inc.
Nov 16, 2016	REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & ...	The firm received complaints of cracks in the weld on the head of the mallet. In the reported ca...	Class II	Smith & Nephew, Inc.
Nov 16, 2016	LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time R...	The LightCycler¿ 480 algorithm used for the LightMix¿ Zika rRT-PCR Test, EUA (catalog number 079...	Class II	Roche Molecular Systems, Inc.
Nov 15, 2016	SOMATOM Definition Flash System, x-ray, tomography, computed Intended to pro...	Software update that provides software and firmware bug-fixes to improve system performance	Class II	Siemens Medical Solutions USA, 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.