Browse Device Recalls

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

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Date	Product	Reason	Class	Firm
Sep 15, 2014	GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical...	mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation o...	Class II	GE OEC Medical Systems, Inc
Sep 15, 2014	ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidura...	Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AF...	Class II	Arrow International Inc
Sep 15, 2014	Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System)...	tubing within the system that drains CSF may leak or disconnect from the joints and may result in...	Class II	Codman & Shurtleff, Inc.
Sep 14, 2014	Philips Expression Information Portal (IP5) Model 865471. The IP5 is intend...	Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notificati...	Class II	Invivo Corporation
Sep 12, 2014	nordicICE 2.3.14 Image processing software package used by trained profess...	An error was discovered in the interpretation of certain DICOM header tags that may lead to incor...	Class II	NordicNeuroLab AS
Sep 12, 2014	ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution ...	Stability of the ADVIA Centaur Cleaning Solution is not assured	Class III	Siemens Healthcare Diagnostics, Inc
Sep 12, 2014	Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roch...	The default references for normal values are inconsistent between cobas b 221 and other blood gas...	Class III	Roche Diagnostics Operations, Inc.
Sep 12, 2014	Prescription eyeglass safety lenses. Vision correction	Prescription eyeglass safety lenses did not meet specifications.	Class II	Eyemart Express Ltd
Sep 11, 2014	Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ...	Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen...	Class II	The Binding Site Group, Ltd.
Sep 11, 2014	Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II...	Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen...	Class II	The Binding Site Group, Ltd.
Sep 11, 2014	ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6....	17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may ex...	Class II	Abbott Ireland Diagnostics Division
Sep 11, 2014	Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"600...	Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen...	Class II	The Binding Site Group, Ltd.
Sep 11, 2014	ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System...	Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of ...	Class II	Intuitive Surgical, Inc.
Sep 11, 2014	Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Produ...	Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen...	Class II	The Binding Site Group, Ltd.
Sep 11, 2014	MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is inte...	Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen...	Class II	The Binding Site Group, Ltd.
Sep 11, 2014	Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 L...	Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen...	Class II	The Binding Site Group, Ltd.
Sep 11, 2014	Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit ...	Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen...	Class II	The Binding Site Group, Ltd.
Sep 11, 2014	The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed...	Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order tha...	Class II	Philips Medical Systems (Cleveland) Inc
Sep 10, 2014	Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm, ...	A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Len...	Class II	Intertrade Imports Inc.
Sep 10, 2014	Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Ad...	A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Len...	Class II	Intertrade Imports Inc.
Sep 9, 2014	Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile...	The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cort...	Class II	Zimmer, Inc.
Sep 8, 2014	Lock nuts for titanium traction tongs are used in traction skull tongs for tr...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Hudson braces are bone cutting and drilling instruments that are used without...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Replacement screw non-springloaded traction tongs are skull tongs for tractio...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Traction tong replacement screws, non-springloaded are used in traction skull...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Philips Expression MR200 MRI Patient Monitoring System Model 866120	During production, excess metal (aluminum) debris was found stuck to the cling plastic that cover...	Class II	Invivo Corporation
Sep 8, 2014	Hudson cerebellar extensions are bone cutting and drilling instruments that a...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Manual trephines are bone cutting and drilling instruments that are used with...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Cushing burrs are bone cutting and drilling instruments that are used without...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Tonometers are manual devices intended to measure intraocular pressure by app...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	An external vein stripper is an extravascular device used to remove a section...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	A trocar is a sharp-pointed instrument used with a cannula for piercing a ves...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Hudson burrs are bone cutting and drilling instruments that are used without ...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	VITROS 5600 Integrated System, System Product Code 6802413. For use in the...	Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the...	Class II	Ortho-Clinical Diagnostics
Sep 8, 2014	Xoran MiniCAT X-ray imaging device	Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.	Class II	Xoran Technologies, LLC
Sep 8, 2014	Galt trephines are bone cutting and drilling instruments that are used withou...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Titanium fixation screws, springloaded are used in traction skull tongs for t...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	CVB distraction screws are bone cutting and drilling instruments that are use...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Cou...	Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound d...	Class III	Coloplast Manufacturing US, LLC
Sep 8, 2014	Cushing perforating drills are bone cutting and drilling instruments that are...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Cloward Spanner gauges are bone cutting and drilling instruments that are use...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Pro...	Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the...	Class II	Ortho-Clinical Diagnostics
Sep 8, 2014	Gardner-Wells wrenches are used in traction skull tongs for traction used to ...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Manual bunnell cranial drills are bone cutting and drilling instruments that ...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	McKenzie Perforator Drills are bone cutting and drilling instruments that are...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	An endometrial suction curette is a device used to remove material from the u...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	A circumcision clamp is an instrument used to compress the foreskin of the pe...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Schoitz weights are manual devices used with Schoitz tonometers and are inten...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx ...	The pediatric breathing circuits can crack prior to and during use.	Class I	Teleflex Medical
Sep 8, 2014	A uterine tenaculum is a hook-like instrument used to seize and hold the cerv...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, 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.