Browse Device Recalls

1,092 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,092 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 1,092 FDA device recalls in OH.

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DateProductReasonClassFirm
Feb 10, 2014 The Thermedx Fluid Management System is designed to provide irrigation fluids... A vendor changed the manufacturing process of a component used in the canister ring that may affe... Class II Thermedx LLC
Feb 3, 2014 OneTray Sealed Sterilization Containers Product Usage: A rigid sterilizat... The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at ... Class II Innovative Sterlization Technologies LLC
Jan 23, 2014 Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive,... The firm was notified by a customer of a cracked spring in the handle of the RCD1 device. Class II Atricure Inc
Jan 8, 2014 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or ... The incorrect voltage component was placed into the device during manufacturing. This may make th... Class II Cincinnati Sub-Zero Products Inc
Dec 19, 2013 Single and Dual use Emission Computer Tomography gamma cameras (BrightView XC... Three problems were reported to the firm: When positioning for a relative 180 degree non circu... Class II Philips Medical Systems (Cleveland) Inc
Dec 19, 2013 Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System ... During internal testing, the Brilliance CT Big Bore was found to be out of tolerance for radio fr... Class II Philips Medical Systems (Cleveland) Inc
Dec 19, 2013 VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, ... STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY¿ SixCe... Class II Steris Corporation
Dec 11, 2013 Latex Dental Dams labeled as Non-Latex Dental Dams Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. Dur... Class II Coltene Whaledent Inc
Dec 9, 2013 Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips... Patient images exhibited ring artifacts. Class II Philips Medical Systems (Cleveland) Inc
Dec 5, 2013 GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare Sys... The TF Big Bore patient table experienced mechanical binding during horizontal table motion resul... Class II Philips Medical Systems (Cleveland) Inc
Dec 4, 2013 Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brillianc... Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical ... Class II Philips Medical Systems (Cleveland) Inc
Dec 4, 2013 ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distribu... The recalling firm determined that visual inspections of the fork joints behind the detector that... Class II Philips Medical Systems (Cleveland) Inc
Dec 4, 2013 Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model ... The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisiti... Class II Philips Medical Systems (Cleveland) Inc
Nov 21, 2013 SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS ... Customers indicated fluctuations in environmental conditions sites and gradual degradation/deform... Class II Steris Corporation
Oct 18, 2013 AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mob... The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or ma... Class II Steris Corporation
Oct 15, 2013 ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark ... RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative b... Class II Radiometer America Inc
Oct 11, 2013 Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Br... If the couch, with the footrest extension attached, is positioned where the table travel is withi... Class II Philips Medical Systems (Cleveland) Inc
Sep 30, 2013 Adjustable Gastric Band, packaged alone in transparent PETG inner and outer b... During aging studies, the firm determined that the gastric belts were unable to pass the test req... Class II Ethicon Endo-Surgery Inc
Sep 30, 2013 Adjustable Gastric Band, packaged alone in transparent PETG inner and outer b... During aging studies, the firm determined that the gastric belts were unable to pass the test req... Class II Ethicon Endo-Surgery Inc
Sep 30, 2013 Adjustable Gastric Band, packaged alone in transparent PETG inner and outer b... During aging studies, the firm determined that the gastric belts were unable to pass the test req... Class II Ethicon Endo-Surgery Inc
Sep 10, 2013 VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STER... STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM ... Class II Steris Corporation
Sep 3, 2013 BrightView XCT is a gamma camera for Single Photon Emission Computed Tomograp... Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain... Class II Philips Medical Systems (Cleveland) Inc
Sep 3, 2013 Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 M... During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Opera... Class II Cincinnati Sub-Zero Products Inc
Aug 31, 2013 Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower ... The snap-on fixtures of the backrest cushion on the Mobile Shower and Toilet Commode Aquatec Ocea... Class II Invacare Corporation
Aug 30, 2013 Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brillia... There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with p... Class II Philips Medical Systems (Cleveland) Inc
Aug 29, 2013 Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley... The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle o... Class II Steris Corporation
Aug 16, 2013 Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installa... Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the ev... Class II Philips Medical Systems (Cleveland) Inc
Aug 15, 2013 Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Me... Dr¿ger Medical GmbH has notified STERIS of the potential for a break in the drive screw contained... Class II Steris Corporation
Aug 9, 2013 Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagno... During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and... Class II Sonogage Inc
Aug 7, 2013 Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1... There is a potential for water to collect in the vent pipe elbow in the magnet venting system. W... Class II Philips Medical Systems (Cleveland) Inc
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

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.