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.

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Date	Product	Reason	Class	Firm
Jul 30, 2013	Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product U...	Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series e...	Class II	Getinge Disinfection
Jul 19, 2013	Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile...	Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system durin...	Class II	Blue Belt Technologies MN
Jun 11, 2013	Sodium Bicarbonate, USP Provided bulk as raw material - label not applicabl...	Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Ol...	Class II	Church & Dwight Inc
May 23, 2013	Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, ...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; si...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; singl...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; sing...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; singl...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO;...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; ...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; sin...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single ...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, E...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single u...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; si...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single us...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; singl...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single us...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
Mar 15, 2013	IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model I...	Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information...	Class II	Intuitive Surgical, Inc.
Mar 15, 2013	IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da ...	Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information...	Class II	Intuitive Surgical, Inc.
Feb 11, 2013	Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC My...	Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL...	Class II	Microbiologics Inc
Feb 8, 2013	Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part ...	Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a s...	Class II	Zimmer, Inc.
Jan 29, 2013	Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide...	Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross m...	Class II	Vascular Solutions, Inc.
Dec 31, 2012	Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T...	RhMK product fungal contamination.	Class III	Diagnostic Hybrids Inc
Nov 13, 2012	Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissu...	The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the ...	Class II	Leica Microsystems, Inc.
Nov 5, 2012	MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardia...	The seal between the white polyethylene and the clear plastic may be missing on the Hand Controll...	Class II	Medrad Inc
Oct 10, 2012	The product is a lyophilized growth supplement for use with dehydrated cultur...	The product may contain low level microbial contamination which could result in incorrect results.	Class II	Remel Inc
Sep 28, 2012	VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Resear...	Potiential for a waste fluid overflow condition to accur while running decontamination cycles on ...	Class II	Ventana Medical Systems Inc
Sep 28, 2012	VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Resear...	Potential for a waste fluid overflow condition to accur while running decontamination cycles on t...	Class II	Ventana Medical Systems Inc
Sep 27, 2012	VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN; Shake 10x; REF 454074; HE0...	Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collecti...	Class II	Cellestis Inc
Sep 27, 2012	Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x...	Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collecti...	Class II	Cellestis Inc
Aug 30, 2012	Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve,...	Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal fr...	Class II	Vascular Solutions, Inc.
Jul 13, 2012	INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use ...	Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have...	Class II	Intuitive Surgical, Inc.
Jul 13, 2012	Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold ...	Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to ...	Class II	Westone Laboratories, Inc.
Jul 13, 2012	KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intend...	Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have...	Class II	Intuitive Surgical, Inc.
Jul 13, 2012	KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The inten...	Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have...	Class II	Intuitive Surgical, Inc.
Jul 13, 2012	ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of...	Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have...	Class II	Intuitive Surgical, Inc.
Jul 13, 2012	KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intend...	Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have...	Class II	Intuitive Surgical, Inc.
Jul 13, 2012	KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intend...	Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have...	Class II	Intuitive Surgical, Inc.
Jun 27, 2012	Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Pr...	Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for...	Class II	Perkinelmer
Jun 18, 2012	Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807	The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed...	Class II	Safe N Simple, LLC
Jun 1, 2012	T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a...	The clear tape, that is intended to aid in the prevention of patients fluids from contacting the...	Class II	Stryker Instruments Div. of Stryker Corporation
Jun 1, 2012	T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide ...	The clear tape, that is intended to aid in the prevention of patients fluids from contacting the ...	Class II	Stryker Instruments Div. of Stryker Corporation
May 29, 2012	Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Contr...	Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. This product gram neg...	Class II	Microbiologics Inc
May 31, 2011	BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral colle...	On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm ...	Class II	BioDerm, Inc.
May 31, 2011	BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The rec...	On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipe...	Class II	BioDerm, Inc.
May 31, 2011	BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with ...	On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm ...	Class II	BioDerm, Inc.
Jun 1, 2009	Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. ele...	Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic...	Class II	Karl Storz Endoscopy America Inc
Jun 1, 2009	Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, c...	Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic...	Class II	Karl Storz Endoscopy America 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.