Browse Device Recalls
1,023 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,023 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 1,023 FDA device recalls — Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 26, 2016 | Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the qu... | There may be a loss of separation between Calibrators A and B which may impact the assay calibrat... | Class III | Diagnostic Hybrids, Inc. |
| Oct 26, 2016 | VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per ... | CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products ... | Class III | Ortho-Clinical Diagnostics |
| Oct 21, 2016 | is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for t... | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. | Class III | Euro Diagnostica AB |
| Oct 21, 2016 | is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for t... | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. | Class III | Euro Diagnostica AB |
| Oct 21, 2016 | is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assa... | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. | Class III | Euro Diagnostica AB |
| Oct 21, 2016 | is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for t... | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. | Class III | Euro Diagnostica AB |
| Oct 14, 2016 | OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigati... | Incorrect lot number on outer kit | Class III | OMNI LIFE SCIENCE |
| Oct 13, 2016 | Brilliance iCT Computed Tomography X-ray system, Model 728306 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Oct 13, 2016 | Ingenuity Core Computed Tomography X-ray system, Model 728321 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Oct 13, 2016 | Brilliance ICT SP Computed Tomography X-ray system, Model 728311 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Oct 13, 2016 | IQon Spectral CT Computed Tomography X-ray system, Model 728332 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Oct 13, 2016 | Ingenuity Core 128 Computed Tomography X-ray system, Model 728323 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Oct 13, 2016 | Ingenuity CT Computed Tomography X-ray system, Model 728326 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Oct 11, 2016 | RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U | Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged ... | Class III | Stryker Instruments Div. of Stryker Corporation |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catal... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 25, 2016 | Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the di... | Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage tempe... | Class III | Acumedia Manufacturers, Inc. |
| Sep 2, 2016 | Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, ... | Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 4... | Class III | Siemens Healthcare Diagnostics Inc |
| Sep 2, 2016 | Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812,... | Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 4... | Class III | Siemens Healthcare Diagnostics Inc |
| Aug 25, 2016 | Dimension Vista IRON Flex reagent cartridges | Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and D... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Aug 25, 2016 | Dimension IRON Flex reagent cartridges | Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and D... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Aug 25, 2016 | Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freez... | Products contain international package insert and not the correct USA package insert | Class III | CooperSurgical, Inc. |
| Aug 25, 2016 | Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawi... | Products contain international package insert and not the correct USA package insert | Class III | CooperSurgical, Inc. |
| Aug 12, 2016 | Arthrex Suture Washer | The device was assembled incorrectly. Suture and washer were not assembled; components were place... | Class III | Arthrex, Inc. |
| Aug 8, 2016 | Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Produc... | Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage tempe... | Class III | Acumedia Manufacturers, Inc. |
| Aug 2, 2016 | LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassett... | Incorrect expiration date on the magnetic strip that does not match the labeled expiration date. | Class III | Alere San Diego, Inc. |
| Jul 28, 2016 | VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product... | A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than ex... | Class III | ORTHO-CLINICAL DIAGNOSTICS |
| 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 | 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 | 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 | 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 | 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 | 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., 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 | 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. 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 18, 2016 | BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label s... | Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. Th... | Class III | Becton, Dickinson and Company, BD Biosciences |
| Jul 12, 2016 | Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: Th... | Software malfunction; The action being taken due to the device becoming inoperable due to softwa... | Class III | ELITech Group B.V. |
| Jul 11, 2016 | Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 ... | The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator ... | Class III | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Jul 7, 2016 | The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF devi... | This field action is being initiated following the firm's discovery of a procedural error in the ... | Class III | Zimmer Trabecular Metal Technology, Inc. |
| Jul 5, 2016 | AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The Amed... | Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may e... | Class III | Branan Medical Corporation |
| Jul 5, 2016 | Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software ... | Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the ... | Class III | Siemens Healthcare Diagnostics Inc |
| Jul 1, 2016 | The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressur... | Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm. | Class III | Circulatory Technology Inc |
| Jun 30, 2016 | Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incuba... | An internal review of an available product found that the Information For Use only contained Engl... | Class III | C.R. Bard, Inc. |
| Jun 29, 2016 | SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK St... | Labeling problem | Class III | C.R. Bard, Inc. |
| Jun 22, 2016 | Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, 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.