Browse Device Recalls
2,522 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,522 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 2,522 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 2, 2015 | Best Practice Kits containing certain production lots of Endo GIA Ultra Unive... | Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... | Class II | Medtronic |
| Nov 30, 2015 | Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: F... | Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike ad... | Class II | Baxter Healthcare Corp. |
| Nov 30, 2015 | Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.... | Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike ad... | Class II | Baxter Healthcare Corp. |
| Nov 30, 2015 | Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, ... | Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike ad... | Class II | Baxter Healthcare Corp. |
| Nov 20, 2015 | IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Numbe... | During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ... | Class II | Boston Scientific Corp |
| Nov 20, 2015 | IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Numbe... | During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ... | Class II | Boston Scientific Corp |
| Nov 20, 2015 | IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: ... | During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ... | Class II | Boston Scientific Corp |
| Nov 20, 2015 | IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M00... | During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ... | Class II | Boston Scientific Corp |
| Nov 19, 2015 | VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access an... | Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricul... | Class II | Cook Inc. |
| Nov 17, 2015 | Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retra... | AAG received a customer complaint that corrosion had been found by a hospitals central sterile s... | Class II | Aesculap, Inc. |
| 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 | ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-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 | EDI BZO Uncut Sheet - Cup*, Item No. 160170 | 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 | 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-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 | ImmuTest 12 Panel Dip Card, Item No. IMD-12MO3 | 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 6 Drugs w/Adul, Item No. PSCupA-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 | DrugSmart 9 Test Cup (BUP), Item No. 60960D | 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 11 Panel w/ Adulterant, Item No. I-DXA-1117-131 | 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 | RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA | 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 Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-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 12 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 6 Panel Dip Card w/Adult (AU), Item No. PSDA-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 Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D | 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 10 Test Cup (PCP & OXY), Item No. 61020D | 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 CLIA Waived w/Adulteration, Item No. IMCA-7MT-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 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300 | 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 8 Panel Dip Card, Item No. PSD-8P | 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 6 DRUG CASSETTE, Item No. MTPA-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 | ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300 | 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 w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA... | 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 11 Pnl Drug Screen Cup w/ Adult, 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 | ProScreen 6 Panel Dip Drug Screen, Item No. PSD-6BUPO3 | 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 | DrugCheck Waived 12 Panel Cup w/Adult, Item No. 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 | 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300,... | 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 10 Panel w/Adulterant, Item No. I-DXA-1107-142 | 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 8 Drug, Item No. PSCup-8P-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 | 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 |
| 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 | 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 | 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 | 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 | 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 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 | 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 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 | 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 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 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 | 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 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 |
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.