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 |
|---|---|---|---|---|
| Feb 26, 2013 | IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog ... | Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control in... | Class III | Alere San Diego, Inc. |
| Feb 26, 2013 | Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Nu... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Numbe... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 ... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Numbe... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex P... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: ... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part N... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 19, 2013 | Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003... | Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with t... | Class III | Remel Inc |
| Feb 15, 2013 | ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management ... | Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrec... | Class III | Horiba Instruments, Inc dba Horiba Medical |
| Feb 14, 2013 | BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 m... | The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags whic... | Class III | Becton Dickinson & Company |
| Feb 8, 2013 | Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Ave... | Orthodontic brackets distributed was incorrectly labeled. | Class III | Ultradent Products, Inc. |
| Feb 4, 2013 | Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavo... | Incorrect packaging of regular set and fast set cartridges. | Class III | Ultradent Products, Inc. |
| Feb 4, 2013 | Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, ... | Incorrect packaging of regular set and fast set cartridges. | Class III | Ultradent Products, Inc. |
| Jan 24, 2013 | D3000I Advantage Drive System, 230v, surgical instrument motor. Product Us... | 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 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. |
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.