Browse Device Recalls

1,067 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,067 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 1,067 FDA device recalls in OH.

Clear
DateProductReasonClassFirm
Nov 1, 2017 Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) ... One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to... Class II Philips Medical Systems (Cleveland) Inc
Oct 23, 2017 Disposable Curved Circular Staplers Product Usage: Staplers have applicat... There is a potential for the devices to create staples that do not meet formed staple height spec... Class II Ethicon Endo-Surgery Inc
Oct 20, 2017 Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with ... The ultrasound probe may not have adequate protection against electrical shock hazards. Class II Hitachi Medical Systems America Inc
Oct 6, 2017 Philips Ingenuity Core 128 computed tomography x-ray system Numerous issues related to software Brilliance iCT 4.1.6 software version. Class II Philips Medical Systems (Cleveland) Inc
Oct 6, 2017 Philips Ingenuity CT computed tomography x-ray system Numerous issues related to software Brilliance iCT 4.1.6 software version. Class II Philips Medical Systems (Cleveland) Inc
Oct 6, 2017 Philips Ingenuity Core computed tomography x-ray system Numerous issues related to software Brilliance iCT 4.1.6 software version. Class II Philips Medical Systems (Cleveland) Inc
Oct 6, 2017 Philips Brilliance 64 computed tomography x-ray system Numerous issues related to software Brilliance iCT 4.1.6 software version. Class II Philips Medical Systems (Cleveland) Inc
Sep 28, 2017 AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay... The firm has become aware of a potential issue that may affect the mixing motor drive harness and... Class II Tosoh Bioscience Inc
Sep 28, 2017 V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000) Correction to update sterilizer software to prohibit the use of expired sterilant prior to the st... Class II Steris Corporation
Jul 27, 2017 A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be u... Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3... Class II Zimmer Surgical Inc
Jul 27, 2017 A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, In... Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3... Class II Zimmer Surgical Inc
Jul 11, 2017 Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tom... Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, da... Class II Philips Medical Systems (Cleveland) Inc
Jul 11, 2017 Brilliance iCT - Model 728306 Computed Tomography X-ray systems Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, da... Class II Philips Medical Systems (Cleveland) Inc
Jun 15, 2017 Vis-U-All High Temperature Tubing 14"x100'. One roll per box; 10 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 15, 2017 Vis-U-All High Temp 5.5"x10" 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 Temperature Tubing 4"x100'. One roll per box; 10 boxes per cas... 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"x16" 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 10.5"x28" Self Seal Pouch 100 pouches per box; 4 boxes pe... 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 Temperature Tubing 6"x100'. One roll per box; 10 boxes per cas... 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 Temperature Tubing 9"x100'. One roll per box; 10 boxes per cas... 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 5"x15" Heat 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 5"x15" 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 16"x16" Self Seal Pouch 100 pouches per box; 6 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"x16" Heat Seal Pouch 100 pouches per box; 9 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"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 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

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.