Browse Device Recalls
1,040 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,040 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 1,040 FDA device recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Jun 22, 2016 | Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple ... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that u... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple te... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For ... | The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the a... | Class III | Ortho-Clinical Diagnostics |
| Jun 22, 2016 | Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test th... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple ... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple tes... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 21, 2016 | Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF ... | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... | Class III | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26... | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... | Class III | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF P... | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... | Class III | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, R... | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... | Class III | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF... | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... | Class III | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36... | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... | Class III | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF ... | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... | Class III | MicroPort Orthopedics Inc. |
| Jun 7, 2016 | Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as o... | Instructions For Use had incorrect lot number and calibrator values | Class III | Tosoh Bioscience, Inc. |
| Jun 1, 2016 | PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix ... | BD has determined that the PhoenixSpec AP Calibrator referenced in this recall from the following... | Class III | Becton Dickinson & Co. |
| Jun 1, 2016 | PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoeni... | BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the fol... | Class III | Becton Dickinson & Co. |
| May 24, 2016 | VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used ... | Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VI... | Class III | Ortho-Clinical Diagnostics |
| May 17, 2016 | cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Inf... | Kit labeled with the incorrect expiration date. | Class III | Roche Molecular Systems, Inc. |
| May 16, 2016 | enGen Laboratory Automation System, Product Code engen, Software Versions enG... | If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numeri... | Class III | Ortho-Clinical Diagnostics |
| May 9, 2016 | VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784,... | Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products... | Class III | ORTHO-CLINICAL DIAGNOSTICS |
| May 6, 2016 | Ariol is an automated scanning microscope and image analysis system. It is in... | An issue during the manufacturing process caused systems to have an improperly activated Windows ... | Class III | Leica Biosystems Richmond Inc. |
| May 5, 2016 | The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Am... | Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the... | Class III | Siemens Healthcare Diagnostics, Inc. |
| May 5, 2016 | The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration... | Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the... | Class III | Siemens Healthcare Diagnostics, Inc. |
| May 2, 2016 | CytoVision Image Analysis and Capture System, an automated cell-locating devi... | Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was asso... | Class III | Leica Biosystems Richmond Inc. |
| Apr 25, 2016 | Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-8... | Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips w... | Class III | GSK Consumer Healthcare |
| Apr 19, 2016 | The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunctio... | There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will pr... | Class III | Ortho-Clinical Diagnostics |
| Apr 15, 2016 | VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated qu... | Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials. | Class III | Biomerieux France Chemin De L'Or |
| Apr 14, 2016 | CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, w... | During a recent Ohio site inspection by the FDA it was discovered that warning statements needed ... | Class III | Affymetrix Inc |
| Mar 31, 2016 | Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog... | Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some ... | Class III | Biocare Medical, LLC |
| Mar 30, 2016 | ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710,... | The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two ina... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Mar 23, 2016 | Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gel... | Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016.... | Class III | Acumedia Manufacturers, Inc. |
| Mar 18, 2016 | BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro ... | The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect stor... | Class III | Becton, Dickinson and Company, BD Biosciences |
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.