Browse Device Recalls
2,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,602 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 2,602 FDA device recalls in 2020.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 25, 2020 | Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - ... | Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 25, 2020 | Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Singl... | Subsequent failure of catheters in the field and failed quality testing | Class I | Medtronic Vascular |
| Aug 25, 2020 | Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, ... | Subsequent failure of catheters in the field and failed quality testing | Class I | Medtronic Vascular |
| Aug 25, 2020 | Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Nu... | Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble dete... | Class II | Terumo Cardiovascular Systems Corporation |
| Aug 24, 2020 | Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expirat... | Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping le... | Class II | Boston Scientific Corporation |
| 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 | Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXI... | The third-party brand latex micro surgical gloves packaged within specific custom packs may have ... | Class II | Alcon Research, LLC |
| Aug 24, 2020 | Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm. | Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it... | Class II | Exactech, Inc. |
| Aug 24, 2020 | Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm. | Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it... | Class II | Exactech, Inc. |
| Aug 24, 2020 | EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indic... | Multiple or incorrect expiration dates were provided on the affected designation labels. | Class II | Smith & Nephew, Inc. |
| 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 24, 2020 | Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component ... | The firm has received reports concerning the patient fiducial disk separating from the body and u... | Class II | Imactis |
| Aug 21, 2020 | 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged ... | Lack of sterility assurance of the 30-0171 | Class II | North American Rescue LLC. |
| Aug 21, 2020 | SwiftHook sold as the following: a. Individually as SwiftHook b. Included w... | Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook com... | Class II | Handicare AB |
| Aug 20, 2020 | Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 063... | Recent internal verification studies found the current RF interference claim to no longer be met ... | Class II | Roche Diagnostics Operations, Inc. |
| Aug 20, 2020 | Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56... | Holding force of the Positioning Arm can be reduced by prolonged non-use. | Class II | Brainlab AG |
| Aug 19, 2020 | Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-... | Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 19, 2020 | Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_... | Calibration offset between the central CT image plane and the external RT lasers has been set aut... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 19, 2020 | MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient ... | Examination gloves were shipped inadvertently, without to verify barrier integrity. | Class II | Ansell Healthcare Products LLC |
| 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 |
| Aug 18, 2020 | Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number ... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 17, 2020 | Speed Stitch Needle Cassette | Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result,... | Class II | ArthroCare Corporation |
| Aug 14, 2020 | NM/CT 860, SPECT/CT | Rotor bearing screws were found loose on detector. | Class II | GE Healthcare, LLC |
| Aug 14, 2020 | Discovery 670 DR Model # H3100BT | Rotor bearing screws were found loose on detector. | Class II | GE Healthcare, LLC |
| Aug 14, 2020 | NM 830 Model # H3910AC | Rotor bearing screws were found loose on detector. | Class II | GE Healthcare, LLC |
| Aug 14, 2020 | Dual Mobility Vivacit-E Bearing, Model Number 110031009 | The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size... | Class II | Zimmer Biomet, Inc. |
| Aug 14, 2020 | NM/CT 870 CZT Model # H3906CW | Rotor bearing screws were found loose on detector. | Class II | GE Healthcare, LLC |
| Aug 14, 2020 | NM/CT 870 DR Model # H3100AS | Rotor bearing screws were found loose on detector. | Class II | GE Healthcare, LLC |
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.