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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Oct 25, 2012 | 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization ... | The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed ... | Class III | Volk Optical Inc |
| Oct 24, 2012 | Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #88... | Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 24, 2012 | Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission... | Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 24, 2012 | Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, ... | Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 24, 2012 | Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, ... | Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 8, 2012 | Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intend... | RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The en... | Class II | Radiometer America Inc |
| Oct 4, 2012 | PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routi... | Damage to the packaging may have compromised the sterility of the device. | Class II | Ethicon Endo-Surgery Inc |
| Sep 28, 2012 | Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model ... | Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to s... | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 28, 2012 | Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomograp... | Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the E... | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 18, 2012 | Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips... | The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents th... | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 11, 2012 | Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 P... | Philips was notified that when performing post processing with the Brilliance Workspace Portal pl... | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 10, 2012 | Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to... | The potential exists for the wheel to rotate freely despite engagement of hub brake. | Class II | Invacare Corporation |
| Aug 31, 2012 | The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system i... | Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causin... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 28, 2012 | The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole B... | Philips was notified that the system logout in software version 2.3.6 is now longer and may somet... | Class III | Philips Medical Systems (Cleveland) Inc |
| Aug 24, 2012 | MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT S... | On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 21, 2012 | Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual ... | A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumu... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 17, 2012 | Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device... | The firm recalled the device after learning of a possible deviation in the stimulus luminance of ... | Class II | Haag-Streit USA Inc |
| Aug 10, 2012 | QKC1692E The QKC1692E Quick Connect device connects endoscopes to the ste... | STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was una... | Class II | Steris Corporation |
| Aug 9, 2012 | AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, O... | The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15... | Class II | AmeriWater Inc |
| Aug 8, 2012 | Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 1... | Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a... | 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.