Browse Device Recalls

1,062 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,062 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 1,062 FDA device recalls in OH.

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Date	Product	Reason	Class	Firm
Jul 22, 2013	MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-...	A pinch point at the end of the table top can cause injury.	Class II	Philips Medical Systems (Cleveland) Inc
Jul 16, 2013	Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA el...	The products may have been stored at temperatures outside their required storage conditions.	Class II	Assuramed
Jul 16, 2013	ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store ...	The products may have been stored at temperatures outside their required storage conditions.	Class II	Assuramed
Jul 16, 2013	DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality...	The products may have been stored at temperatures outside their required storage conditions.	Class II	Assuramed
Jul 16, 2013	Brilliance iCT and Brilliance iCT SP These systems are intended to produce...	An artifact that resembles thrombus may appear on the image.	Class II	Philips Medical Systems (Cleveland) Inc
Jul 10, 2013	Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland,...	The firm became aware of the problem when a ratchet cover plate on a device was returned for repa...	Class II	Pemco Inc
Jul 5, 2013	pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. ...	RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on...	Class II	Radiometer America Inc
Jul 5, 2013	Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40,...	The patient support may move in an unintended manner if the footswitch cover impinges on the foot...	Class II	Philips Medical Systems (Cleveland) Inc
Jun 18, 2013	CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per ca...	There is a possibility of elevated temperatures in the seat pad. In addition, the hospital cord s...	Class II	Invacare Corporation
Jun 10, 2013	pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, O...	RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner sol...	Class II	Radiometer America Inc
Jun 4, 2013	Invacare Power Wheelchair, one per box To provide mobility to a person res...	Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended accelerat...	Class II	Invacare Corporation
May 20, 2013	STERIS Fine Traction Device, one unit per box Product Usage: The Fine Tra...	A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-re...	Class II	Steris Corporation
May 15, 2013	Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data E...	During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-1...	Class II	Cincinnati Sub-Zero Products Inc
May 15, 2013	AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-6...	Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/le...	Class II	Tosoh Smd Inc
May 13, 2013	ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack ...	Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (EC...	Class II	Ethicon Endo-Surgery Inc
May 7, 2013	Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-ste...	This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air ...	Class II	Zimmer Surgical Inc
May 7, 2013	The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafti...	This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air ...	Class II	Zimmer Surgical Inc
May 7, 2013	Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile gr...	This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air ...	Class II	Zimmer Surgical Inc
Apr 25, 2013	Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Comp...	A complaint was received in which a hospital physicist indicated the dosage was too high on the H...	Class II	Leibel-Flarsheim Company LLC
Apr 25, 2013	BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medic...	Philips has received one report from the field that there was an unexpected motion of the detecto...	Class II	Philips Medical Systems (Cleveland) Inc
Apr 17, 2013	Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube use...	The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.	Class I	Bryan Medical Inc
Apr 15, 2013	Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, I...	Philips Healthcare received reports from the field that certain Brilliance CT 64, Ingenuity Core,...	Class II	Philips Medical Systems (Cleveland) Inc
Apr 12, 2013	LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk n...	Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating ...	Class II	Ethicon Endo-Surgery Inc
Apr 12, 2013	LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Tra...	Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating ...	Class II	Ethicon Endo-Surgery Inc
Apr 12, 2013	LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Pro...	Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating ...	Class II	Ethicon Endo-Surgery Inc
Apr 9, 2013	Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 i...	The incorrect manual may have been packaged with this product. UVB-080 devices may have included ...	Class III	National Biological Corp
Apr 8, 2013	Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is...	The incorrect manual may have been packaged with this product. UVB-083 devices may have included...	Class III	National Biological Corp
Apr 8, 2013	Endopath Electrosurgery Probe Plus II, twelve (12) different devices, includi...	The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in th...	Class II	Ethicon Endo-Surgery Inc
Mar 21, 2013	Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanner...	If the operator selects a patient name from the worklist using the mouse and then selects a diffe...	Class II	Philips Medical Systems (Cleveland) Inc
Mar 12, 2013	Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Wat...	Philips Healthcare received a report from the field stating when they viewed the CTDIVol informat...	Class II	Philips Medical Systems (Cleveland) Inc
Mar 7, 2013	Torrent" irrigation tubing. Product Usage: The Torrent irrigation sys...	The firm was notified by their customers that there was a water leakage from the white tubing con...	Class II	US Endoscopy Group Inc
Mar 4, 2013	Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, ...	During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be upd...	Class II	Steris Corporation
Feb 15, 2013	Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brillian...	This field change order is being released to update software and customer release notes to the af...	Class II	Philips Medical Systems (Cleveland) Inc
Feb 12, 2013	AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat an...	The control boards alarm set points and temperature tolerances allowed for erroneous activation ...	Class II	Steris Corporation
Feb 12, 2013	Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., Intel...	Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with ...	Class II	Philips Medical Systems (Cleveland) Inc
Jan 31, 2013	Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. ...	Hitachi discovered a software error that can occur when simultaneously scanning a patient while p...	Class II	Hitachi Medical Systems America Inc
Jan 21, 2013	Ingenuity TF PET/CT. Diagnostic imaging system	The system may not default to the same gating trigger with which the data were acquired. This cou...	Class II	Philips Medical Systems (Cleveland) Inc
Jan 14, 2013	Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate...	Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labe...	Class II	Atricure 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
Dec 20, 2012	Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and ...	Philips Healthcare received reports from the field stating the patient table on a system had an u...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 20, 2012	Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emis...	Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 19, 2012	Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray...	The four screws that secure the patient table top to the carrier became loose, which caused the t...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 3, 2012	Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: B...	Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0x...	Class II	Philips Medical Systems (Cleveland) Inc
Nov 29, 2012	CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381,...	Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in...	Class II	Thermo Fisher Scientific (Asheville) LLC
Nov 27, 2012	TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, ...	RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Claus...	Class II	Radiometer America Inc
Nov 6, 2012	Ethicon Endo-Surgery Inc. The ENSEAL¿ G2 Tissue Sealers are indicated for bip...	Potential for self activation while the device is in use, which may result in unintended thermal ...	Class II	Ethicon Endo-Surgery Inc
Nov 6, 2012	Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and ...	Following their receipt of several customer complaints, Invacare recalled their height adjustable...	Class II	Invacare Corporation
Nov 5, 2012	MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The ...	An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified v...	Class II	Integra LifeSciences Corporation
Nov 5, 2012	MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) i...	An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified v...	Class II	Integra LifeSciences Corporation
Oct 30, 2012	Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill B...	The firm was notified by a customer that there was a burr on the inside end of the drill bit resu...	Class II	Orthohelix Surgical Designs 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.