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 |
|---|---|---|---|---|
| Jan 25, 2017 | SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAI... | DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage p... | Class III | DeRoyal Industries 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 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 5, 2017 | VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, I... | The company received a customer complaint for the inability to calibrate VITROS Chemistry Product... | Class III | Ortho-Clinical Diagnostics |
| Dec 23, 2016 | Optilite IgG4 Kit Product Code: LK009.OPT.A | A change to the lower end of the measuring range and product insert did not reflect the change.Th... | Class III | The Binding Site Group, Ltd. |
| Dec 21, 2016 | AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1... | Beckman Coulter initiated a design change to update the Automate PC image to accommodate the oper... | Class III | Beckman Coulter Inc. |
| Dec 21, 2016 | Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Produc... | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | Class III | PerkinElmer Health Sciences, Inc. |
| Dec 21, 2016 | DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number... | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | Class III | PerkinElmer Health Sciences, Inc. |
| Dec 21, 2016 | AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number:... | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | Class III | PerkinElmer Health Sciences, Inc. |
| Dec 13, 2016 | Roth Net Polyp Retrieval | The firm was notified that the expiration date on the outer carton is different than the expirati... | Class III | US Endoscopy Group Inc |
| Dec 5, 2016 | EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-... | Unique Device Identifier (UDI) is missing from outer kit box label. | Class III | PerkinElmer Health Sciences, Inc. |
| Nov 30, 2016 | Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only. | The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the... | Class III | Ecolab Inc |
| Nov 18, 2016 | OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical... | Labeled as a 48mm Cortical Screw but measuring at 50mm | Class III | OrthoPediatrics Corp |
| Nov 16, 2016 | DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum | A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrat... | Class III | PerkinElmer Health Sciences, Inc. |
| Nov 10, 2016 | Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) P... | Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due t... | Class III | OraSure Technologies, Inc. |
| Nov 7, 2016 | Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase I... | Due to a customer experiencing complaints on bone fraction of assay not being in range. The co... | Class III | Helena Laboratories, Inc. |
| Oct 31, 2016 | HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotl... | HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the requir... | Class III | Smiths Medical ASD, Inc. |
| 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. |
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.