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 |
|---|---|---|---|---|
| Jul 4, 2016 | Zimmer¿ Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . ... | The surface coating applied to the device is blistering, peeling and discoloring after usage over... | Class II | Zimmer Surgical Inc |
| Jul 4, 2016 | Zimmer¿ Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width pla... | The surface coating applied to the device is blistering, peeling and discoloring after usage over... | Class II | Zimmer Surgical Inc |
| Jul 4, 2016 | Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimme... | The surface coating applied to the device is blistering, peeling and discoloring after usage over... | Class II | Zimmer Surgical Inc |
| Jul 4, 2016 | Zimmer¿ Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width pla... | The surface coating applied to the device is blistering, peeling and discoloring after usage over... | Class II | Zimmer Surgical Inc |
| Jul 4, 2016 | Zimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Wid... | The surface coating applied to the device is blistering, peeling and discoloring after usage over... | Class II | Zimmer Surgical Inc |
| Jul 4, 2016 | Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. T... | The surface coating applied to the device is blistering, peeling and discoloring after usage over... | Class II | Zimmer Surgical Inc |
| Jul 4, 2016 | Zimmer¿ Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate i... | The surface coating applied to the device is blistering, peeling and discoloring after usage over... | Class II | Zimmer Surgical Inc |
| Jun 21, 2016 | Ingenuity Flex, model # 728317; Intended to produce cross- sectional images ... | Supplier design change contributed to a thinner plastic which was used as part of the cover on th... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 21, 2016 | lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per... | The rear gradation scale was screen printed upside down on the flowmeter gauge. | Class II | Invacare Corporation |
| Jun 21, 2016 | Ingenuity Core, model # 728326; Intended to produce cross- sectional images ... | Supplier design change contributed to a thinner plastic which was used as part of the cover on th... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 21, 2016 | Ingenuity Core 128, model #728323; Intended to produce cross- sectional imag... | Supplier design change contributed to a thinner plastic which was used as part of the cover on th... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 21, 2016 | Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one ... | The rear gradation scale was screen printed upside down on the flowmeter gauge. | Class II | Invacare Corporation |
| Jun 21, 2016 | Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- se... | Supplier design change contributed to a thinner plastic which was used as part of the cover on th... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 21, 2016 | Brilliance iCT model #728306; Intended to produce cross- sectional images of... | Supplier design change contributed to a thinner plastic which was used as part of the cover on th... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 14, 2016 | Big Bore Oncology tomography X-ray system scanner, model number 728243. The... | Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainl... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 14, 2016 | Big Bore Radiology tomography X-ray system scanner, model number 728244. Th... | Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainl... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 25, 2016 | BrightView X, model #882478; gamma camera designed for single or dual detecto... | The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, re... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 25, 2016 | BrightView XCT Upgrade Model 882454 | The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, re... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 25, 2016 | BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed... | The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, re... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 23, 2016 | OT1000 Series Orthopedic Surgical Tables | STERIS has identified that the pivot pin assembly located on the table top may become loose preve... | Class II | Steris Corporation |
| May 19, 2016 | Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MS... | A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package. | Class II | Devicor Medical Products Inc |
| May 18, 2016 | Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 ... | US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needl... | Class II | US Endoscopy Group Inc |
| May 17, 2016 | Calix T PEEK Lumbar System, TLIF Rasp | The trials and rasps used to prepare the surgical site for placement of the implant may become de... | Class II | X Spine Systems Inc |
| May 17, 2016 | Calix P PEEK Lumbar System, PLIF Rasp | The trials and rasps used to prepare the surgical site for placement of the implant may become de... | Class II | X Spine Systems Inc |
| May 17, 2016 | Calix P PEEK Lumbar System, PLIF Trial | The trials and rasps used to prepare the surgical site for placement of the implant may become de... | Class II | X Spine Systems Inc |
| May 17, 2016 | Calix T PEEK Lumbar System, TLIF Trial | The trials and rasps used to prepare the surgical site for placement of the implant may become de... | Class II | X Spine Systems Inc |
| Apr 29, 2016 | Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the... | Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance iCT, Model No. 728306; To produce cross-sectional images of the b... | Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, co... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Ingenuity CT Model No. 728326; To produce cross-sectional images of the body. | Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Ingenuity Core Model No. 728321; To produce cross-sectional images of the body. | Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuit... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the ... | Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance 64 CT Model 728231; To produce cross-sectional images of the body. | Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 produ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 20, 2016 | MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic t... | The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 20, 2016 | MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnos... | The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 14, 2016 | CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, w... | During a recent Ohio site inspection by the FDA it was discovered that warning statements needed ... | Class III | Affymetrix Inc |
| Apr 8, 2016 | Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to pr... | The firm became aware of a problem where the system may not map Varian drive after CT user logout... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 8, 2016 | Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended t... | The firm became aware of a problem where the system may not map Varian drive after CT user logout... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 8, 2016 | Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Inten... | The firm became aware of a problem where the system may not map Varian drive after CT user logout... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 8, 2016 | Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Inten... | The firm became aware of a problem where the system may not map Varian drive after CT user logout... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 1, 2016 | Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenu... | Philips Healthcare received reports from the field that certain Ingenuity Core systems running so... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 1, 2016 | Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The In... | Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 1, 2016 | Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilli... | Philips Healthcare received reports from the field that certain Brilliance 64 systems running sof... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Ingenuity Core Computed Tomography X-ray systems is intended to produce cross... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produ... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to p... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce c... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to pr... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 15, 2016 | Junction Boxes, Product Usage: The Invacare Bariatric home care bed is i... | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric... | Class II | Invacare Corporation |
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.