Browse Device Recalls

960 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 960 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 960 FDA device recalls.

Clear

Date	Product	Reason	Class	Firm
Jul 19, 2015	Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVL...	Punctured blister packages were detected during the packaging process at the manufacturing site. ...	Class II	Elcam Medical, Inc.
Jul 19, 2015	Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring...	Punctured blister packages were detected during the packaging process at the manufacturing site. ...	Class II	Elcam Medical, Inc.
Jul 16, 2015	Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Conce...	Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.	Class II	Fresenius Medical Care Holdings, Inc.
Jun 26, 2015	Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8...	Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated...	Class III	Getinge Disinfection Ab
May 20, 2015	NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodial...	Bacterial contamination.	Class II	Fresenius Medical Care Holdings, Inc.
May 6, 2015	enGen Laboratory Automation System (enGen System), Product Code ENGEN, config...	Recapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of ent...	Class II	Ortho-Clinical Diagnostics
Apr 29, 2015	Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquef...	Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a...	Class II	Richard-Allan Scientific Company
Apr 29, 2015	Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Muco...	Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a...	Class II	Richard-Allan Scientific Company
Apr 24, 2015	D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with...	A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fe...	Class II	GE Healthcare
Mar 27, 2015	CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous...	There is a potential for a hole to be present in the outer tray of a limited number of pain contr...	Class II	B. Braun Medical, Inc.
Mar 26, 2015	Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound o...	The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not cons...	Class II	PhotoMedex, Inc.
Mar 23, 2015	ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.	Siemens internal investigation confirmed that current contamination avoidance settings do not pre...	Class II	Siemens Healthcare Diagnostics, Inc.
Mar 10, 2015	FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX ...	This recall is being conducted because a cohesive band used to package the devices contains latex...	Class II	Microtek Medical Inc
Mar 10, 2015	FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE,...	This recall is being conducted because a cohesive band used to package the devices contains latex...	Class II	Microtek Medical Inc
Mar 10, 2015	FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, ...	This recall is being conducted because a cohesive band used to package the devices contains latex...	Class II	Microtek Medical Inc
Mar 10, 2015	FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MO...	This recall is being conducted because a cohesive band used to package the devices contains latex...	Class II	Microtek Medical Inc
Feb 11, 2015	Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves...	Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes label...	Class II	Sybron Dental Specialties
Dec 18, 2014	Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer	Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positi...	Class II	Roche Diagnostics Operations, Inc.
Dec 17, 2014	Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in ...	Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur...	Class II	Zimmer Gmbh
Dec 17, 2014	CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in ske...	Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur...	Class II	Zimmer Gmbh
Dec 17, 2014	Metasul Femoral Head - A modular head component is used in conjunction with a...	Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur...	Class II	Zimmer Gmbh
Dec 17, 2014	Metasul Femoral Head - indicated for total hip arthroplasty for treatment of...	Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur...	Class II	Zimmer Gmbh
Dec 17, 2014	CoCr Femoral Head - A modular head component is used in conjunction with a fe...	Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur...	Class II	Zimmer Gmbh
Nov 26, 2014	GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS...	Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the w...	Class II	Getinge Disinfection Ab
Oct 21, 2014	Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and RE...	All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile...	Class II	Gyrus Acmi, Incorporated
Oct 8, 2014	Wound Management Tray Ill, Catalog number 900-540. Used by medical staff t...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Cataract Pack, Catalog # 900-944 Used by medical staff to perform patient ...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Liposuction Pack, catalog #900-2656 Used by medical staff to perform patie...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	C-Section Surgical Pack, Catalog # 900-921A Used by medical staff to perfo...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by med...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Extremity PACK, catalog #900-2615 Used by medical staff to perform patient...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perfo...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Laparoscopy Chole Pack, Catalog number 900-1688. Used by medical staff to ...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff ...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Major Laparotomy Pack, Catalog number 900-036. Used by medical staff to pe...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Use...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to ...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Cesarean Pack, Catalog number 900-1689. Used by medical staff to perform p...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical st...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to per...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Premium OB Pack, Catalog number 900-1297. Used by medical staff to perform...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Open Heart Tray, Catalog number 900-1196C Used by medical staff to perfor...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Laparoscopy Pack, Catalog number 900-1967. Used by medical staff to perfor...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Femoral Pack, Catalog number 900-164. Used by medical staff to perform pat...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Gown Surgical Non Reinforced XXL, Catalog number 900-2566. Used by medical...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Total Hysterectomy, catalog #900-2415 Used by medical staff to perform pat...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Cystoscopy Pack III, catalog #900-2482 Used by medical staff to perform pa...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Fanfold Drape, Catalog number 900-633. Used by medical staff to perform pa...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Femoral Angiography Pack, Catalog number 900-796. Used by medical staff to...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, 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.