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
Jun 13, 2024	Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide...	IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ...	Class II	Steris Corporation
Jun 13, 2024	Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups prov...	IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ...	Class II	Steris Corporation
May 13, 2024	Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and...	One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contami...	Class II	SIGHT DIAGNOSTICS LTD
May 13, 2024	Non-sterile, single use, disposable gloves intended for medical purposes to b...	Firm received complaints regarding skin irritation when using the gloves, disintegration of the g...	Class II	SVS LLC
Apr 17, 2024	CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9...	Potential contamination of the product with latex adhesive residual.	Class II	Cardinal Health 200, LLC
Mar 20, 2024	24K Premium Lense, Distributed by Updream Inc.	Contact lenses recalled due to potential bacterial contamination.	Class II	Ontact Inc
Feb 29, 2024	BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix ...	Products were found to have confirmed drug cross contamination prior to release may lead to incor...	Class II	Becton Dickinson & Co.
Jan 16, 2024	Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be use...	Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used fo...	Class II	Olympus Corporation of the Americas
Dec 15, 2023	ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model...	Devices may not be rendered sterile due to an internal gap that may be present on some devices ca...	Class II	Globus Medical, Inc.
Dec 4, 2023	Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC	The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympu...	Class II	Olympus Corporation of the Americas
Dec 4, 2023	Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150...	The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympu...	Class II	Olympus Corporation of the Americas
Oct 24, 2023	CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A	There is the potential that cooler-heater devices may contain bacterial contamination which could...	Class II	CardioQuip, LLC
Oct 24, 2023	CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A	There is the potential that cooler-heater devices may contain bacterial contamination which could...	Class II	CardioQuip, LLC
Sep 25, 2023	Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ure...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Mobile airway scope-diagnosis and observation to access airway anatomy, endot...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided ne...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Colonoscope: for endoscopy and endoscopic surgery within the lower digestive ...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Small intestinal videoscope-For endoscopy and endoscopic surgery within the u...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number:...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and oth...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Gastrointestinal videoscope-indicated for use within the upper digestive trac...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: H...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Tracheal videoscope- For airway management, which includes observation to acc...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Cystonephroscope-endoscopic diagnosis and treatment within the bladder, ureth...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidn...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasoun...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Colonoscope-indicated for use within the lower digestive tract (including the...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lum...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Bronchoscope-for endoscopy and endoscopic surgery within the airways and trac...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class III	Aizu Olympus Co., Ltd.
Sep 25, 2023	Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) a...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Tracheal fiberscope-airway management, which includes observation to access a...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower dig...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Jun 23, 2023	UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿...	There is an improperly performed weld between the cone of the sheath lock and tube of the obturat...	Class II	Scholly Fiberoptic Gmbh
Mar 31, 2023	Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 9...	The liquid buffer component in the affected test kit lots was determined to have bacterial contam...	Class I	SD Biosensor, Inc.
Jan 30, 2023	Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix RE...	Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause cont...	Class II	DiaSorin Molecular LLC
Jan 30, 2023	Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150;...	Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause cont...	Class II	DiaSorin Molecular LLC
Dec 21, 2022	EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within t...	A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance o...	Class II	Olympus Corporation of the Americas
Dec 8, 2022	RadiaLux Lighted Retractor (Pink), REF: 50-101-1	Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of conta...	Class II	Medtronic Navigation, Inc.
Nov 24, 2022	RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used ...	Complaints of leaking packets were received.	Class I	Emergent Protective Products USA Inc
Nov 15, 2022	ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive	ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) d...	Class II	ConvaTec, Inc
Nov 7, 2022	R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, ...	For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration...	Class III	R & D Systems, Inc.
Sep 7, 2022	THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S...	Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irr...	Class II	Johnson & Johnson Surgical Vision, Inc.
Aug 12, 2022	Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark...	There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the p...	Class II	CooperSurgical, Inc.
Aug 12, 2022	Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark...	There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the p...	Class II	CooperSurgical, Inc.
Jul 20, 2022	NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.	There is a potential of no result leading to possible delayed result due to contamination of extr...	Class II	bioMerieux, Inc.
Jun 1, 2022	NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3	The product was potentially exposed to below-recommended storage temperatures, which may cause le...	Class II	Fresenius Medical Care Holdings, Inc.
May 9, 2022	BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches...	May have the potential for leakage at the housing component of the stopcock, may result in delay ...	Class II	Becton Dickinson & Company

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.