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 |
|---|---|---|---|---|
| Jun 15, 2017 | Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes p... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per ca... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 11, 2017 | Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code ... | This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The ... | Class II | Tosoh Bioscience Inc |
| Jun 11, 2017 | Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 0229... | This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The ... | Class II | Tosoh Bioscience Inc |
| Jun 7, 2017 | Brilliance iCT (Model No. 728306), Software Version 4.1.6 Product Usage: ... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 7, 2017 | Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 ... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 7, 2017 | Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 7, 2017 | Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: C... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 7, 2017 | Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usag... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 7, 2017 | Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Co... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 7, 2017 | Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 ... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 7, 2017 | Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: ... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 7, 2017 | IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Produ... | It was reported that scanners running certain software versions provide confusing information in ... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 2, 2017 | Arietta 70 Ultrasound System Intended for use by trained personnel (doctor... | The strength of the arm mounting mechanism was insufficient and had to be redesigned. | Class II | Hitachi Medical Systems America Inc |
| Apr 25, 2017 | Assist Bed Rail - 6632 | A typographical error was noted within the user manual for the 6632 Assist Bed Rail which could r... | Class II | Invacare Corporation |
| Apr 4, 2017 | MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of... | There is a potential for the slope of the standard curve to fail to meet the assay validation req... | Class II | Diagnostic Hybrids, Inc. |
| Mar 31, 2017 | Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM | There is a risk that the pinion gear in the device could fail under extreme use cases. | Class II | Ethicon Endo-Surgery Inc |
| Mar 22, 2017 | AIA-360 Analyzer is capable of performing two methods of immunoassay: an immu... | The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the t... | Class II | Tosoh Bioscience Inc |
| Mar 9, 2017 | Hemotherm CE, model 400CE, Heater-Cooling Device | Improperly rated fuses were used in the manufacture of the device. | Class II | Cincinnati Sub-Zero Products Inc |
| Mar 8, 2017 | Ferno PROFlexx¿ Model 28Z Chair Cot | The recall was initiated as a result of the detection of an incorrect nut used in manufacturing. | Class II | Ferno-Washington Inc |
| Feb 28, 2017 | Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to s... | The device did not have Revolve Stereo Probe labeling, no product code indicating the size and le... | Class II | Devicor Medical Products Inc |
| Feb 24, 2017 | BrightView SPECT model number 882480 BrightView and BrightView X are gamma c... | The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 24, 2017 | BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma c... | The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone... | Class III | Philips Medical Systems (Cleveland) Inc |
| Feb 24, 2017 | BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma c... | The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 24, 2017 | BrightView XCT model number 882482 BrightView and BrightView X are gamma cam... | The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 23, 2017 | Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems i... | Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 23, 2017 | Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems in... | When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary ga... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 31, 2017 | 882478: BrightView X designed for single or dual detector nuclear imaging acc... | Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door inte... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 31, 2017 | 882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for singl... | Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door inte... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 31, 2017 | 882480: BrightView designed for single or dual detector nuclear imaging accom... | Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door inte... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 27, 2017 | Hand Foot II, UVB-138. One device per box; device is surrounded by foam inse... | The wiring may allow the lamps to turn on with the key switch rather than the timer. | Class II | National Biological Corp |
| Jan 19, 2017 | AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointesti... | Expired expiration dates are listed on the pouches. | Class III | Applied Medical Technology Inc |
| Jan 19, 2017 | AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Naso... | Expired expiration dates are listed on the pouches. | Class III | Applied Medical Technology Inc |
| Jan 6, 2017 | Hitachi Oasis MRI System - C-Spine Coil | The customer indicated that the coil balun was hot to the touch when removing the coil from the p... | Class II | Hitachi Medical Systems America Inc |
| Jan 5, 2017 | EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra O... | There is a possibility for data to be stored under the wrong patient on the DICOM Server followin... | Class II | Haag-Streit USA 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.