Medical device recalls
39137 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-06-30FDA-DeviceCardinal Health Inc.Class IIAEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- 2021-06-30FDA-DeviceCardinal Health Inc.Class IIFREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- 2021-06-30FDA-DeviceCardinal Health Inc.Class IIFREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- 2021-06-30FDA-DeviceCardinal Health Inc.Class IIFREESTYLE LANCETS 28G 100CT Item Number:2975670
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- 2021-06-30FDA-DeviceGE Healthcare, LLCClass IICase Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
If a certain sequence of events occur, the pdf test report that belongs to one patient will appear in a different patient's record when viewed in an Electronic Medical Record (EMR) or a similar system.
- 2021-06-30FDA-DevicePear Therapeutics, Inc.Class IIreSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS results should not have resulted in access to a wheel spin.
- 2021-06-30FDA-DevicePear Therapeutics, Inc.Class IIreSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS results should not have resulted in access to a wheel spin.
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class IIProbe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class IIProbe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class IIProbe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class IIProbe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class IIProbe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class IIHays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class IIHays Ultrasound kit Item ID: H1000SE
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class IIProbe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class IITransducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class IITransducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class IIProbe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class IIProbe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class II6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class IIProbe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class II6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class II6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class IIProbe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceExact Medical Manufacturing, Inc.Class IIProbe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
No 510k for the product to be used in a natural or surgical opening to the body
- 2021-06-30FDA-DeviceBeckman Coulter Inc.Class IIAccess SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.
- 2021-06-30FDA-DeviceBeckman Coulter Inc.Class IIAccess SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.
- 2021-06-30FDA-DevicePhilips Medical Systems NederlandsClass IIPhilips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.
- 2021-06-30FDA-DeviceBioFire Diagnostics, LLCClass IIBioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.
- 2021-06-30FDA-DeviceVentec Life Systems, Inc.Class IIVentec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy.
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