Device recalls
Device recalls with the root cause, the firm, the products and the recall status. 59,344 records; openFDA updated it 2026-10-05. About this dataset
Newest records
- Other8,928
- Device Design7,666
- Under Investigation by firm6,888
- Process control6,551
- Nonconforming Material/Component5,963
- Software design3,513
- Packaging1,666
- Component design/selection1,609
- HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 050601671206…FDA page
HeartSine Technologies Ltd · Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
- McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fish…FDA page
Alere San Diego, Inc. · hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
- Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part…FDA page
Alere San Diego, Inc. · hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
- Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Par…FDA page
Alere San Diego, Inc. · hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
- Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-10…FDA page
Alere San Diego, Inc. · hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
- EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with soft…FDA page
Bard Peripheral Vascular Inc · Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pre…
- Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VAFDA page
Volcano Corp · Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
- Computed Tomography X-ray System, Model: uCT 530 with softwareFDA page
Shanghai United Imaging Healthcare Co., Ltd. · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are…
- Computed Tomography X-ray System, Model: uCT 550 with softwareFDA page
Shanghai United Imaging Healthcare Co., Ltd. · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are…
- Computed Tomography X-ray System, Model: uCT 760 with softwareFDA page
Shanghai United Imaging Healthcare Co., Ltd. · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are…
- Computed Tomography X-ray System, Model: uCT 780 with softwareFDA page
Shanghai United Imaging Healthcare Co., Ltd. · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are…
- Computed Tomography X-ray System, Model: uCT ATLAS with softwareFDA page
Shanghai United Imaging Healthcare Co., Ltd. · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are…
- Computed Tomography X-ray System, Model: uCT ATLAS Astound with softwareFDA page
Shanghai United Imaging Healthcare Co., Ltd. · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are…
- Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with softwareFDA page
Shanghai United Imaging Healthcare Co., Ltd. · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are…
- Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with softwareFDA page
Shanghai United Imaging Healthcare Co., Ltd. · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are…
- Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with softwareFDA page
Shanghai United Imaging Healthcare Co., Ltd. · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are…
- Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with softwareFDA page
Shanghai United Imaging Healthcare Co., Ltd. · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are…
- Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with softwareFDA page
Shanghai United Imaging Healthcare Co., Ltd. · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are…
- Positron Emission Tomography and Computed Tomography System, Model: uMI 780FDA page
Shanghai United Imaging Healthcare Co., Ltd. · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are…
- Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Descri…FDA page
American Nitrile Operations Llc · Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infecti…
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.