Browse Device Recalls
4,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,602 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 4,602 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 1, 2015 | UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Pa... | Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 ... | Class II | Beckman Coulter Inc. |
| Dec 1, 2015 | MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan... | Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/... | Class II | Beckman Coulter Inc. |
| Dec 1, 2015 | MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Posit... | Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/... | Class II | Beckman Coulter Inc. |
| Dec 1, 2015 | UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Pa... | Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 ... | Class II | Beckman Coulter Inc. |
| Dec 1, 2015 | MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Posit... | Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/... | Class II | Beckman Coulter Inc. |
| Dec 1, 2015 | MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan... | Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/... | Class II | Beckman Coulter Inc. |
| Dec 1, 2015 | UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Pa... | Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 ... | Class II | Beckman Coulter Inc. |
| Nov 25, 2015 | RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number:... | Incorrect version of Instructions for Use were shipped to two US customers. | Class II | RenovoRx, Inc. |
| Nov 23, 2015 | 0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41... | This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 m... | Class II | Intuitive Surgical, Inc. |
| Nov 23, 2015 | 30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-4... | This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 m... | Class II | Intuitive Surgical, Inc. |
| 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 18, 2015 | FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A f... | The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fung... | Class II | Hardy Diagnostics |
| Nov 18, 2015 | TCM CombiM Modules 903-111 | Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that ca... | Class II | Radiometer America 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 |
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.