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 |
|---|---|---|---|---|
| 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 |
| Aug 11, 2014 | Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend Perimeter Mattress, P... | The firm found that the top cover of the mattresses were delaminating. | Class II | Primus Medical LLC |
| Jul 28, 2014 | RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data process... | Class II | Radiometer America Inc | |
| Jul 27, 2014 | IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and Intelli... | The following software issues have been identified in the affected products. Problem 1: When reo... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 11, 2014 | Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the S... | Revision B of the tissue shields of the device was 7 mm longer than the previous design. | Class II | X Spine Systems Inc |
| Jun 30, 2014 | Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: ... | STERIS has identified that deformation of the washers door handle pin may occur when the door ha... | Class III | Steris Corporation |
| Jun 27, 2014 | The STERIS 4085 General Surgical Table Product Usage: is an electro-hydra... | STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifol... | Class II | Steris Corporation |
| Jun 25, 2014 | Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquat... | The Aquatec¿ Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result... | Class II | Invacare Corporation |
| Jun 24, 2014 | MK5 NX Controller--Wheelchair controller | M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were ... | Class II | Invacare Corporation |
| Jun 23, 2014 | BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat... | Flat Panel Display (FPD) failed to remain securely locked in the deployed position. | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 18, 2014 | GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: ... | When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 25, 2014 | Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usag... | The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a ... | Class II | Hitachi Medical Systems America Inc |
| Apr 22, 2014 | illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 ... | Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a res... | Class II | Meridian Bioscience Inc |
| Apr 7, 2014 | Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR) | Separation events have occurred, including the VIPR separating from the Aluminum cylinder. | Class II | Western / Scott Fetzer Company |
| Apr 4, 2014 | Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harm... | Potential for the welded seam in affected monitor spring arms to crack and/or break. | Class II | Steris Corporation |
| Apr 1, 2014 | Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT seri... | A customer reported that the table top had become free floating. A Field Service Engineer (FSE) ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 27, 2014 | Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brillian... | Block assembly-lock stop subframe of service latch was not manufactured to engineering specificat... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 20, 2014 | Stirling Ultracold Portable Shuttle, ULT-25. Storage for cold-chain manage... | The external power supply input is overheating at the connection to the freezer. | Class II | Global Cooling Inc |
| Mar 11, 2014 | IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model ... | During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Corr... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 10, 2014 | Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC V... | Slippage of the radius drive belt in the relative 180 degree orientation of the superior position... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2014 | Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical System... | A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions wo... | 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.