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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 27, 2016 | The surgical table is a stand alone unit. Three (3) floor locking cylinders a... | The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were... | Class II | Schaerer Medical USA Inc |
| Sep 27, 2016 | Replacement floor locking cylinders for the Schaerer model 7300 surgical tabl... | The floor locking cylinders are contained in the base of the Schaerer 7300 model surgical tables.... | Class II | Schaerer Medical USA Inc |
| Sep 22, 2016 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product ... | There is a potential for a component failure of the device which could necessitate medical interv... | Class II | AtriCure, Inc. |
| Sep 22, 2016 | COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA ... | Due to product design and process control, part of the device can separate and remain behind when... | Class II | AtriCure, Inc. |
| Sep 1, 2016 | VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144 | Adhesive border was not sticky enough. | Class II | CellEra LLC |
| Aug 24, 2016 | Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography... | The infant performance test did not meet the test specification for the Infant Head Uniformity te... | Class II | Philips Medical Systems |
| Aug 24, 2016 | Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X... | The infant performance test did not meet the test specification for the Infant Head Uniformity te... | Class II | Philips Medical Systems |
| Aug 24, 2016 | Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray... | The infant performance test did not meet the test specification for the Infant Head Uniformity te... | Class II | Philips Medical Systems |
| Aug 24, 2016 | Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray... | The infant performance test did not meet the test specification for the Infant Head Uniformity te... | Class II | Philips Medical Systems |
| Jul 20, 2016 | Ingenuity Core128, Model number 728323 Product Usage: Computed Tomography... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Ingenuity Core, Model number 728321 Product Usage: Computed Tomography X-... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Brilliance 16, Model number 728246 Product Usage: Computed Tomography X-r... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Brilliance BigBore Radiology CT Model number 728244 Product Usage: Comput... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Compu... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Brilliance 64 CT Model number 728231 Product Usage: Computed Tomography X... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Brilliance CT 16 Power, Model number 728240 Product Usage: Computed Tomog... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 15, 2016 | Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOP... | Quality control identified a component issue where the pinion gear in the device could fail under... | Class II | Ethicon Endo-Surgery Inc |
| Jul 15, 2016 | Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH E... | Quality control identified a component issue where the pinion gear in the device could fail under... | Class II | Ethicon Endo-Surgery Inc |
| Jul 14, 2016 | MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specifi... | There is a possibility of low volume and/or leaking standard bottles. | Class II | Diagnostic Hybrids, Inc. |
| Jul 4, 2016 | Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device... | Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied... | Class II | Zimmer Surgical Inc |
| 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 |
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.