Browse Device Recalls
3,029 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,029 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 3,029 FDA device recalls in 2016.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 26, 2016 | AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLI... | Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PI... | Class II | Howmedica Osteonics Corp. |
| Jul 26, 2016 | AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The Accu... | Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PI... | Class II | Howmedica Osteonics Corp. |
| Jul 26, 2016 | Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two s... | The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone c... | Class II | Encore Medical, Lp |
| Jul 26, 2016 | IntelliVue Patient Monitor Product Usage: The monitors are indicated for ... | If an affected Patient Monitor has been powered on continuously for several months, any displayed... | Class II | Philips Electronics North America Corporation |
| Jul 26, 2016 | ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS brande... | Software patch installation to address several safety issues. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 26, 2016 | PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerat... | Software patch installation to address several safety issues. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 26, 2016 | Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a sof... | Software patch installation to address several safety issues. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 26, 2016 | AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuL... | Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PI... | Class II | Howmedica Osteonics Corp. |
| Jul 25, 2016 | Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate ... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI ... | Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than t... | Class II | Microgenics Corporation |
| Jul 25, 2016 | Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader fo... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochrom... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional m... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance read... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled con... | Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tu... | Class II | Terumo Cardiovascular Systems Corp |
| Jul 22, 2016 | OEC 9800, fluoroscopic x-ray system | A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monito... | Class II | GE OEC Medical Systems, Inc |
| Jul 22, 2016 | OEC UroView 2800, fluoroscopic x-ray system | A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monito... | Class II | GE OEC Medical Systems, Inc |
| Jul 21, 2016 | FPS 35mm x 3.5 mm non-locking screw | Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws. | Class II | Ortho Solutions Inc |
| Jul 21, 2016 | INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine ... | Device can fail during operation. | Class II | Inovo, Inc |
| Jul 21, 2016 | SMR allen wrench 5 mm, product code 9013.50.210 | Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of th... | Class II | Limacorporate S.p.A |
| Jul 21, 2016 | Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, ... | Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "position... | Class II | Integra LifeSciences Corp. |
| Jul 21, 2016 | RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that conta... | Sterility seal integrity failures on the Renasys Sterile Transparent Film | Class II | Smith & Nephew, Inc. |
| Jul 20, 2016 | Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOS... | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... | Class III | Sterling Diagnostics, Inc. |
| 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 | Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in ... | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... | Class III | Sterling Diagnostics, Inc. |
| Jul 20, 2016 | Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in ... | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... | Class III | Sterling Diagnostics, 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 | Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOS... | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... | Class III | Sterling Diagnostics, Inc. |
| Jul 20, 2016 | Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in... | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... | Class III | Sterling Diagnostics, Inc. |
| Jul 20, 2016 | BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, ... | Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specif... | Class II | Cardinal Health |
| Jul 20, 2016 | Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITR... | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... | Class III | Sterling Diagnostics, Inc. |
| Jul 20, 2016 | Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the qu... | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... | Class III | Sterling Diagnostics, Inc. |
| Jul 20, 2016 | Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instruc... | Incorrect drill protocol in the Instructions for Use (IFU) | Class II | Nobel Biocare Usa Llc |
| Jul 20, 2016 | Integra External Fixation System Slotted Post - Small Catalogue #12224228; In... | Through the investigation of reported complaints Integra verified that there have been instances ... | Class II | Integra LifeSciences Corp. |
| Jul 20, 2016 | ROSA Brain 3.0.0 Usage: The device is intended for the spatial positionin... | Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller. | Class II | Zimmer Biomet, Inc. |
| Jul 20, 2016 | Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catal... | Through the investigation of reported complaints Integra verified that there have been instances ... | Class II | Integra LifeSciences Corp. |
| Jul 20, 2016 | ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA... | Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System So... | Class II | Siemens Healthcare Diagnostics, 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 | OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for th... | Failed stability testing at 8 months. This lot produced intermittent false negative results for ... | Class I | OraSure Technologies, Inc. |
| Jul 20, 2016 | Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in th... | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... | Class III | Sterling Diagnostics, Inc. |
| Jul 20, 2016 | Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC U... | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... | Class III | Sterling Diagnostics, 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 19, 2016 | MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, ... | The two bolts that attach the clamping plate to the lateral shaft may break, which could cause th... | Class II | Philips Electronics North America Corporation |
| Jul 19, 2016 | Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used ... | Sterility compromised due to breach in sterile packaging | Class II | Smith & Nephew, Inc. |
| Jul 19, 2016 | TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030 | Novus Scientific is implementing additions to the product's instructions for use concerning certa... | Class II | Novus Scientific Ab |
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.