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 |
|---|---|---|---|---|
| Jan 24, 2013 | D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Sy... | The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207,... | Class III | Linvatec Corp. dba ConMed Linvatec |
| Jan 23, 2013 | Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Pro... | Affected products have a labeled expiration date of one year too long. | Class III | Bion Enterprises Ltd |
| Jan 23, 2013 | Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product... | Affected products have a labeled expiration date of one year too long. | Class III | Bion Enterprises Ltd |
| Jan 23, 2013 | Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product... | Affected products have a labeled expiration date of one year too long. | Class III | Bion Enterprises Ltd |
| Jan 21, 2013 | Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 45821... | Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of the... | Class III | Alere San Diego, Inc. |
| Jan 17, 2013 | KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Mod... | Missing symbols and manufacturing information on the clear carton label. The expiration dating s... | Class III | Carestream Health, Inc. |
| Dec 31, 2012 | Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T... | RhMK product fungal contamination. | Class III | Diagnostic Hybrids Inc |
| Dec 21, 2012 | OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactur... | There is no evidence that a visual inspection was performed on one tray of coverslips. Possibilit... | Class III | Hitachi Chemical Diagnostics Inc |
| Dec 20, 2012 | Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in... | The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no ... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Dec 20, 2012 | Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The... | Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Dec 17, 2012 | Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infu... | Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on J... | Class III | Animas Corporation |
| Dec 6, 2012 | Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit... | Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The c... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Nov 28, 2012 | Immunoradiometric assay. Device is an immunoradiometric assay designed for... | The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of do... | Class III | Siemens Healthcare Diagnostics |
| Nov 28, 2012 | Immunoradiometric assay. | The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of do... | Class III | Siemens Healthcare Diagnostics |
| Nov 28, 2012 | Immunoradiometric assay. Device is an immunoradiometric assay designed for... | The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of do... | Class III | Siemens Healthcare Diagnostics |
| Nov 26, 2012 | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... | GranuFlo Dry Acid Concentrate may show discoloration | Class III | Fresenius Medical Care Holdings, Inc. |
| Nov 26, 2012 | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... | GranuFlo Dry Acid Concentrate may show discoloration | Class III | Fresenius Medical Care Holdings, Inc. |
| Nov 26, 2012 | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... | GranuFlo Dry Acid Concentrate may show discoloration | Class III | Fresenius Medical Care Holdings, Inc. |
| Nov 26, 2012 | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... | GranuFlo Dry Acid Concentrate may show discoloration | Class III | Fresenius Medical Care Holdings, Inc. |
| Nov 26, 2012 | Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca... | GranuFlo Dry Acid Concentrate may show discoloration | Class III | Fresenius Medical Care Holdings, Inc. |
| Nov 26, 2012 | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... | GranuFlo Dry Acid Concentrate may show discoloration | Class III | Fresenius Medical Care Holdings, Inc. |
| Nov 26, 2012 | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... | GranuFlo Dry Acid Concentrate may show discoloration | Class III | Fresenius Medical Care Holdings, Inc. |
| Nov 26, 2012 | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... | GranuFlo Dry Acid Concentrate may show discoloration | Class III | Fresenius Medical Care Holdings, Inc. |
| Nov 26, 2012 | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... | GranuFlo Dry Acid Concentrate may show discoloration | Class III | Fresenius Medical Care Holdings, Inc. |
| Nov 21, 2012 | Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry C... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class III | Siemens Healthcare Diagnostics Inc |
| Nov 21, 2012 | Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M ... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class III | Siemens Healthcare Diagnostics Inc |
| Nov 21, 2012 | Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class III | Siemens Healthcare Diagnostics Inc |
| Nov 21, 2012 | Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class III | Siemens Healthcare Diagnostics Inc |
| Nov 21, 2012 | Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mc... | Boxes labeled as CIP5 may contain cartridges of AMP5. | Class III | Remel Inc |
| Nov 21, 2012 | Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class III | Siemens Healthcare Diagnostics Inc |
| Nov 21, 2012 | Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemis... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class III | Siemens Healthcare Diagnostics Inc |
| Nov 20, 2012 | The Centricity Laboratory System is intended to be an information system desi... | GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Labor... | Class III | GE Healthcare It |
| Nov 19, 2012 | Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic ana... | A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener ... | Class III | Roche Diagnostics Operations, Inc. |
| Nov 7, 2012 | Analyzing system consists of a small and portable analyzer and plastic microc... | Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made fro... | Class III | HemoCue AB |
| Nov 1, 2012 | VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B sur... | Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an ina... | Class III | Ortho-Clinical Diagnostics |
| Oct 25, 2012 | 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization ... | The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed ... | Class III | Volk Optical Inc |
| Oct 22, 2012 | Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88... | Out of range (increased) HDL Cholesterol results. | Class III | Alere San Diego, Inc. |
| Oct 22, 2012 | Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 ... | Out of range (increased) HDL Cholesterol results. | Class III | Alere San Diego, Inc. |
| Oct 10, 2012 | Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP C... | Correlation slope bias and accuracy shift | Class III | Siemens Healthcare Diagnostics, Inc. |
| Oct 3, 2012 | West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 12215... | The firm recalled due to higher reactivity with some samples in the effected lots, which may refl... | Class III | Focus Diagnostics Inc |
| Sep 14, 2012 | Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Leve... | HORIBA Medical Irvine Technical Support received reports from some customers that have experience... | Class III | Horiba Instruments, Inc dba Horiba Medical |
| Sep 14, 2012 | ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot N... | This recall was initiated because some customers were experiencing an alarm during Creatinine cal... | Class III | Horiba Instruments, Inc dba Horiba Medical |
| Sep 6, 2012 | Sterile, single-use, disposable electrosurgical electrode holder. It connect... | The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. ... | Class III | Gynex Corporation |
| Aug 28, 2012 | The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole B... | Philips was notified that the system logout in software version 2.3.6 is now longer and may somet... | Class III | Philips Medical Systems (Cleveland) Inc |
| Aug 22, 2012 | Dual Tip Marker, Sterile Product Usage: A writing instrument intended... | Dual Tip Marker has inconsistent ink flow on the black permanent ink side. | Class III | Viscot Medical LLC |
| Aug 20, 2012 | Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integr... | In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO... | Class III | Microgenics Corporation |
| Aug 15, 2012 | 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 m... | One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chl... | Class III | Amsino Medical USA |
| Aug 15, 2012 | 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL... | One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chl... | Class III | Amsino Medical USA |
| Aug 7, 2012 | 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit con... | Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters be... | Class III | Bard Access Systems |
| Aug 7, 2012 | ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. P... | ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in t... | Class III | Siemens Healthcare 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.