Browse Device Recalls
4,686 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,686 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 4,686 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 20, 2020 | ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 38... | There is a potential that components of the receive coil can reach elevated temperatures which ha... | Class II | Viewray, Inc. |
| Oct 20, 2020 | ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 ... | There is a potential that components of the receive coil can reach elevated temperatures which ha... | Class II | Viewray, Inc. |
| Oct 16, 2020 | DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a cha... | Due to footswitch not meeting required specification for protection from ingress of solids or liq... | Class II | Ra Medical Systems, Inc. |
| Oct 9, 2020 | Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling b... | Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary c... | Class III | Talladium Inc |
| Oct 8, 2020 | CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interven... | There is a potential that the cable of the Flat panel detector may break during a procedure which... | Class II | Canon Medical System, USA, INC. |
| Oct 6, 2020 | Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 | Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box... | Class III | Hardy Diagnostics |
| Oct 5, 2020 | BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a com... | Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression tha... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Oct 1, 2020 | EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: Thi... | The use of deionized water rather than distilled water during the manufacturing process, may have... | Class II | Epitope Diagnostics, Inc. |
| Sep 26, 2020 | AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 us... | Mislabeling; It has been determined that some batteries were improperly labeled and may contain a... | Class III | Advanced Bionics, LLC |
| Sep 26, 2020 | AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 us... | Mislabeling; It has been determined that some batteries were improperly labeled and may contain a... | Class III | Advanced Bionics, LLC |
| Sep 25, 2020 | QUIDEL Sofia SARS Antigen FIA IVD REF 20374 | Due to false positive results. | Class II | Quidel Corporation |
| Sep 21, 2020 | Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM... | Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever ... | Class I | Stryker Neurovascular |
| Sep 17, 2020 | Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lat... | Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all r... | Class II | Quidel Corporation |
| Sep 10, 2020 | t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump ... | Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump bat... | Class II | Tandem Diabetes Care Inc |
| Aug 31, 2020 | Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Clos... | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... | Class II | ICU Medical, Inc. |
| Aug 31, 2020 | 3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning S... | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... | Class II | ICU Medical, Inc. |
| Aug 31, 2020 | 31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chambe... | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... | Class II | ICU Medical, Inc. |
| Aug 31, 2020 | Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx ... | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... | Class II | ICU Medical, Inc. |
| Aug 31, 2020 | 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, S... | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... | Class II | ICU Medical, Inc. |
| Aug 31, 2020 | 76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip ... | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... | Class II | ICU Medical, Inc. |
| Aug 31, 2020 | Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260 | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... | Class II | ICU Medical, Inc. |
| Aug 31, 2020 | 5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 ... | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... | Class II | ICU Medical, Inc. |
| Aug 31, 2020 | 30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1... | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... | Class II | ICU Medical, Inc. |
| Aug 31, 2020 | Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30"... | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... | Class II | ICU Medical, Inc. |
| Aug 31, 2020 | 42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79... | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... | Class II | ICU Medical, Inc. |
| Aug 31, 2020 | 26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z... | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... | Class II | ICU Medical, Inc. |
| Aug 31, 2020 | 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chambe... | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... | Class II | ICU Medical, Inc. |
| Aug 26, 2020 | BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF... | Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjuga... | Class II | Beckman Coulter Inc. |
| Aug 24, 2020 | Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICA... | Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contain... | Class II | Irvine Biomedical Inc, a St. Jude Medical Co. |
| Aug 24, 2020 | Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICA... | Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contain... | Class II | Irvine Biomedical Inc, a St. Jude Medical Co. |
| Aug 18, 2020 | CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Fastect¿ II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "A... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AM... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description):... | XXX | Class II | Ameditech Inc |
| Aug 18, 2020 | MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP3... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item N... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProS... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ ... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-214... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNIN... | The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690... | Class II | Beckman Coulter Inc. |
| Aug 18, 2020 | Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): ... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-10... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA ... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | 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.