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.

Clear
DateProductReasonClassFirm
Feb 27, 2015 Lombart 90D Clear with case Visualization during diagnosis and laser therapy... Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct l... Class III Volk Optical Inc
Feb 27, 2015 Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL IN... Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. Class III Volk Optical Inc
Feb 26, 2015 ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Produ... During an internal inspection of the production process the firm discovered an issue which may ca... Class II Ethicon Endo-Surgery Inc
Feb 19, 2015 Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove ... Should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electri... Class II Steris Corporation
Feb 19, 2015 AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small... STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will ... Class II Steris Corporation
Feb 17, 2015 Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable ... The company has received reports of structural non conformance at the connection between the valv... Class II US Endoscopy Group Inc
Feb 5, 2015 Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce ... 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2015 Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce c... 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2015 Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technol... Philips discovered that a software defect exists in marketed product wherein the sign indication ... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2015 Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cros... 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2015 Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produ... 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2015 Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. ... 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2015 Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence techn... 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... Class II Philips Medical Systems (Cleveland) Inc
Feb 2, 2015 Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corp... The batteries used in the Invacare¿ Pronto¿ Air Personal Transporter models power wheelchairs hav... Class II Invacare Corporation
Jan 31, 2015 Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure ... The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed ... Class I Western / Scott Fetzer Company
Jan 15, 2015 Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (... If the slack in the wires is not routed and secured correctly, flexing of the back pan under the ... Class II Invacare Corporation
Jan 15, 2015 FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power... If the slack in the wires is not routed and secured correctly, flexing of the back pan under the ... Class II Invacare Corporation
Jan 15, 2015 TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power... If the slack in the wires is not routed and secured correctly, flexing of the back pan under the ... Class II Invacare Corporation
Jan 15, 2015 ViewRay System, Radiation Therapy System The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) ... Class II Viewray Incorporated
Jan 9, 2015 Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body. The MRI system safety feature, which lowers the magnetic field in emergency situations, may not w... Class I Alltech Medical Systems America Inc
Jan 7, 2015 Cold Therapy Pad - cold water circulating pad, one unit per package. The pa... Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead t... Class II Cincinnati Sub-Zero Products Inc
Dec 19, 2014 The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. ... Through an investigation of complaints, Integra found that there is the possibility for the locki... Class II Integra LifeSciences Corporation
Dec 8, 2014 ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer th... The ABL90 analyzer does not always use the most recent calibration data to calculate patient resu... Class II Radiometer America Inc
Dec 8, 2014 Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit ... Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion. Class II Philips Medical Systems (Cleveland) Inc
Dec 5, 2014 G- Series Beds; G29 full length bed rails assembly Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of spe... Class II Invacare Corporation
Dec 3, 2014 Ferno Model 35X PROFlexx Stretchers, one unit per package The wheel castor assemblies may be loosening on the stretchers. Class II Ferno-Washington Inc
Nov 26, 2014 Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmon... STERIS has learned that groups of LED lights (modules) contained within the vLED light head may i... Class II Steris Corporation
Nov 21, 2014 Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek ... Affected product may have compromised sterility due to packaging defects. It was determined that ... Class II Atricure Inc
Nov 14, 2014 Powered stretcher chair used during facial and eye surgeries. One chair per p... The firm is finding that the stretcher chair controllers are moving the chairs involuntarily. Class II TransMotion Medical Inc
Nov 13, 2014 FLUTTER Percussor respiratory device, packaged one unit per clear plastic pac... Customer notification that the device may be difficult to open or close. Class II Aptalis Pharmatech Inc.
Nov 12, 2014 BrightView model number: 882478 BrightView X model number: 882480 BrightVie... Unintended detector and gantry movement due to software issues. Class II Philips Medical Systems (Cleveland) Inc
Nov 9, 2014 IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/... Software defect. In certain circumstances, the application may display incorrect measurements of... Class II Philips Medical Systems (Cleveland) Inc
Nov 4, 2014 Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor... Internal testing and investigation of the packaging revealed cracks and holes in primary packaging Class II Pulsion Medical Inc
Nov 4, 2014 BrightView product code: 882478 BrightView X product code: 882480 BrightVie... Software issues Class II Philips Medical Systems (Cleveland) Inc
Oct 31, 2014 Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged on... The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential ... Class II Invacare Corporation
Oct 31, 2014 UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary p... Packaging non-conformance related to the integrity of the sterile pouch seal. Class II US Endoscopy Group Inc
Oct 29, 2014 Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL8... Negative drift on QC during in-use lifetime of CREA membranes can be observed. Class II Radiometer America Inc
Oct 20, 2014 HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are... Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the s... Class II Radiometer America Inc
Oct 16, 2014 MicroVue Bb Plus EIA is packaged as a kit which contains all reagent componen... Samples are quantitating incorrectly, with approximately 50% higher concentration values than pre... Class II Diagnostic Hybrids Inc
Oct 10, 2014 The 5085 is a general surgical table with high patient weight capacity, exten... The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignmen... Class II Steris Corporation
Oct 9, 2014 MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can ... "The orientation of images is displayed incorrectly. When operator chooses gantry on the ri... Class II Philips Medical Systems (Cleveland) Inc
Oct 6, 2014 UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric hand... Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece ... Class II Zimmer Surgical Inc
Oct 1, 2014 Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (in... The caster may separate completely from the device frame causing injury to user. Class II Roscoe Medical Inc
Sep 23, 2014 Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged ... It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the siev... Class II Invacare Corporation
Sep 19, 2014 MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag... Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer Class II Orthohelix Surgical Designs Inc
Sep 15, 2014 AC Powered adjustable bed frame. AC powered adjustable bed frame used in n... Firm received several complaints that the head deck actuator bracket had separated from the bed f... Class II Primus Medical LLC
Sep 11, 2014 The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed... Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order tha... Class II Philips Medical Systems (Cleveland) Inc
Sep 1, 2014 Fluid Management System P4000; for irrigation and fluid warming in laparosco... To correct software bugs that could affect the ability to accurately measure fluid deficit. Class II Thermedx LLC
Aug 18, 2014 Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per ... The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn ... Class II Hitachi Medical Systems America Inc
Aug 12, 2014 PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR3... The device may have a non-conforming component that may cause the device to fire an unformed staple. Class II Ethicon Endo-Surgery 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.