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 |
|---|---|---|---|---|
| Mar 17, 2016 | Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cle... | Foreign material in container | Class III | Cygnus Medical |
| Mar 11, 2016 | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Pa... | There is a potential problem with the cuvette where failure of the cuvette would cause an error m... | Class III | Datascope Corporation |
| Mar 11, 2016 | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Numb... | There is a potential problem with the cuvette where failure of the cuvette would cause an error m... | Class III | Datascope Corporation |
| Mar 11, 2016 | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Specia... | There is a potential problem with the cuvette where failure of the cuvette would cause an error m... | Class III | Datascope Corporation |
| Feb 29, 2016 | Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffe... | Lot was not functioning properly and not exhibiting the correct physical properties. | Class III | AMS Diagnostics, LLC |
| Feb 16, 2016 | Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For us... | Multiple complaints were received from customers indicating that they ordered product 8335(Type 3... | Class III | Richard-Allan Scientific Company |
| Feb 4, 2016 | Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascu... | Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tub... | Class III | Medtronic Perfusion Systems |
| Feb 2, 2016 | Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for ... | The firm discovered that the incorrect lot number was engraved on the product. | Class III | Volk Optical Inc |
| Jan 25, 2016 | BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in ... | Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expi... | Class III | Becton, Dickinson and Company, BD Biosciences |
| Jan 19, 2016 | CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Pe... | The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HI... | Class III | Sorin Group USA, Inc. |
| Jan 18, 2016 | CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Descript... | Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recomm... | Class III | Lab Vision Corporation |
| Jan 15, 2016 | OraQuick HCV Visual Reference Panel Intended to assist new operation in b... | OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Ant... | Class III | OraSure Technologies, Inc. |
| Jan 4, 2016 | REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapte... | Report by a customer of an open package seal. | Class III | C.R. Bard, Inc. |
| Dec 14, 2015 | FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent. | Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting function... | Class III | Becton, Dickinson and Company, BD Biosciences |
| Dec 11, 2015 | CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows:... | Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor ... | Class III | Terumo Cardiovascular Systems Corporation |
| Nov 17, 2015 | ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in... | The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working pr... | Class III | Collagen Matrix Inc |
| Nov 16, 2015 | DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | 11 Panel Card (OPI 300) w/Adult, Item No. 71125AA | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OP | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | 10-Panel Pipette Drug Screen, Item No. PSP-10M | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | BZO Strip Dip Card (300ng/ml)*, Item No. 100170 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | 1 Step 12 Panel Cup, Item No. NBCA-12M-W | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of ... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 10 Drug Panel Cassette Test, Item No. PSP-10PPX | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | DrugSmart 11 Test Cup, Item No. 61127D | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 10 Panel Cup, Item No. PSCup-10M | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6B... | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 5 Panel Dip Card, Item No. PSD-12BUP | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 7 Panel Dip Card, Item No. PSD-7MPB, PSD-7MO, PSD-7M | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup (... | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB300 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech 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.