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
Oct 1, 2014	Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (in...	The caster may separate completely from the device frame causing injury to user.	Class II	Roscoe Medical Inc
Oct 1, 2014	Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spl...	Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was pr...	Class II	Zimmer Dental Inc
Oct 1, 2014	APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plate...	A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of...	Class II	Medartis, Inc.
Oct 1, 2014	Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TS...	Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was pr...	Class II	Zimmer Dental Inc
Oct 1, 2014	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in ...	A software issue may lead to ventilator inoperative situations.	Class I	Nellcor Puritan Bennett Inc. (dba Covidien LP)
Oct 1, 2014	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien ...	Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter...	Class I	Nellcor Puritan Bennett Inc. (dba Covidien LP)
Sep 30, 2014	Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Kn...	Packaging of a device was compromised	Class II	Signal Medical Corporation
Sep 30, 2014	StarMedTec LightTrail¿ Reusable Fibers, 800 um; Material/Part Number: 6457	Product is not cleared for use with lasers other than the Auriga XL system	Class II	Boston Scientific Corporation
Sep 30, 2014	StarMedTec LightTrail¿ Reusable Fibers, 365 um; Material/Part Number: 6453	Product is not cleared for use with lasers other than the Auriga XL system	Class II	Boston Scientific Corporation
Sep 30, 2014	Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-li...	Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on...	Class II	Masimo Corporation
Sep 30, 2014	StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455	Product is not cleared for use with lasers other than the Auriga XL system	Class II	Boston Scientific Corporation
Sep 30, 2014	CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: ...	Incorrect expiration date printed on the MILEX PESSARY KIT packaging	Class III	CooperSurgical, Inc.
Sep 30, 2014	Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C...	Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c...	Class II	Siemens Healthcare Diagnostics, Inc.
Sep 30, 2014	CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Mode...	Incorrect expiration date printed on the MILEX PESSARY KIT packaging	Class III	CooperSurgical, Inc.
Sep 29, 2014	Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system ...	It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update...	Class II	Merge Healthcare, Inc.
Sep 29, 2014	Dharma Cavity Varnish with Fluoride	During an FDA inspection, it was found that the products are being marketed without a cleared 510k.	Class II	Dharma Research, Inc.
Sep 29, 2014	VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemis...	Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Prod...	Class III	Ortho-Clinical Diagnostics
Sep 29, 2014	Dharma Cavity Varnish 15mL	During an FDA inspection it was found that the products are marketed without a cleared 510k.	Class II	Dharma Research, Inc.
Sep 29, 2014	CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-...	Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD&quot...	Class II	Smiths Medical ASD, Inc.
Sep 29, 2014	Integra Selector Kit Sterile single use device A bi-lumen, sterile single us...	Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not pla...	Class II	Integra LifeSciences Corp.
Sep 29, 2014	Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5...	Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam whe...	Class II	Coloplast Manufacturing US, LLC
Sep 29, 2014	ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic ...	Product is mislabeled.	Class II	4-Web Inc.
Sep 26, 2014	Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, No...	These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.	Class II	Merit Medical Systems, Inc.
Sep 26, 2014	Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set ...	MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by ...	Class II	Cook Medical Incorporated
Sep 26, 2014	Amerigel Daily Dressing Packets Wound management	Formulation deviation	Class II	Amerx Health Care Corp.
Sep 26, 2014	Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments ar...	An investigation identified that high level friction may exist between the needle and Mamba sutur...	Class II	Biomet, Inc.
Sep 26, 2014	Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instrume...	An investigation identified that high level friction may exist between the needle and Mamba sutur...	Class II	Biomet, Inc.
Sep 26, 2014	Amerigel Hydrogel Wound Dressing Wound management	Formulation deviation	Class II	Amerx Health Care Corp.
Sep 26, 2014	Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335...	Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortis...	Class II	Siemens Healthcare Diagnostics, Inc
Sep 26, 2014	Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open...	Distortion (noise interference) of the liquid level capacitance can result in air aspiration inst...	Class II	Tecan US, Inc.
Sep 26, 2014	Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments ar...	An investigation identified that high level friction may exist between the needle and Mamba sutur...	Class II	Biomet, Inc.
Sep 26, 2014	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) RE...	The knife handles slot depth is out of specification, so blades may not fit on the handles properly.	Class II	Teleflex Medical
Sep 26, 2014	Amerigel Post-op Surgical Kits Wound management	Formulation deviation	Class II	Amerx Health Care Corp.
Sep 26, 2014	Amerigel Saturated Gauze Dressing Wound management	Formulation deviation	Class II	Amerx Health Care Corp.
Sep 25, 2014	Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Dis...	Product lot did not meet the specification for its disinfectants at the time of manufacture.	Class II	Bausch & Lomb Inc- Greenville Solutions Plant
Sep 25, 2014	ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo ...	The insulin pump may lose time and date settings during a power interruption (such as a battery c...	Class II	Roche Diagnostics Operations, Inc.
Sep 25, 2014	COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear ...	Error in the software. A deviation between reconstructed and planned dose distribution may not b...	Class II	Iba Dosimetry Gmbh
Sep 24, 2014	Foot Switches used with the following systems: Philips Allura Xper Systems; 7...	Loss of key image functionality due to a bent pedal of the Footswitch.	Class II	Philips Medical Systems, Inc.
Sep 24, 2014	Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Arti...	Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)	Class II	Straumann USA, LLC
Sep 24, 2014	Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed...	The Easy-Care Care-Lock feature installed at the foot of the bed may potentially fail to stay eng...	Class II	Joerns Healthcare
Sep 24, 2014	Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a varie...	An investigation identified that the product was incorrectly manufactured as a left humeral trial...	Class II	Biomet, Inc.
Sep 24, 2014	Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters...	Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an ...	Class II	STERILMED, INC.
Sep 24, 2014	siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used o...	Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with...	Class II	Siemens Healthcare Diagnostics, Inc.
Sep 24, 2014	Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Produ...	Loss of key image functionality due to a bent pedal of the Footswitch.	Class II	Philips Medical Systems, Inc.
Sep 23, 2014	Microseal Augmented (20 degrees) Liner, acetabular liner component made from ...	Incorrect dimension on four liners was detected	Class II	Signal Medical Corporation
Sep 23, 2014	ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs ...	Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpreta...	Class II	Ameditech Inc
Sep 23, 2014	Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged ...	It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the siev...	Class II	Invacare Corporation
Sep 23, 2014	Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : A...	A cable inside the C-arm systems may have been routed in an inappropriate manner. Improper routi...	Class II	Siemens Medical Solutions USA, Inc
Sep 23, 2014	ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint L...	Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpreta...	Class II	Ameditech Inc
Sep 23, 2014	ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint La...	Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpreta...	Class II	Ameditech 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.