CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
Richard Wolf GmbH
🏥 Medical Devices Class I - Dangerous
Product labeled as Cutting Electrode may contain BIVAP electrode.
All Recalls
95,114 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.
Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000
Medtronic Neuromodulation
🏥 Medical Devices Class I - Dangerous
Excess nylon flash on the clip.
🏥 Medical Devices Class I - Dangerous
There is a potential for internal leaks within catheters.
GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX
Stryker Medical Division of Stryker
🏥 Medical Devices Class I - Dangerous
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
Carl Zeiss Meditec
🏥 Medical Devices Class I - Dangerous
Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.
IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
Stryker Medical Division of Stryker
🏥 Medical Devices Class I - Dangerous
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
🏥 Medical Devices Class I - Dangerous
There is a potential that 7F sheaths are packaged as 10F sheaths.
🏥 Medical Devices Class I - Dangerous
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm
Bard Peripheral Vascular
🏥 Medical Devices Class I - Dangerous
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
🏥 Medical Devices Class I - Dangerous
Due to high glucose test results when using the blood collection cards.
Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Medline Industries
🏥 Medical Devices Class I - Dangerous
The kits may contain an expired component.
FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
BioFire Diagnostics
🏥 Medical Devices Class I - Dangerous
Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325
Biomet
🏥 Medical Devices Class I - Dangerous
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
🏥 Medical Devices Class I - Dangerous
There is a potential for internal leaks within catheters.
Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Medline Industries
🏥 Medical Devices Class I - Dangerous
The kits may contain an expired component.
Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302
Biomet
🏥 Medical Devices Class I - Dangerous
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
🏥 Medical Devices Class I - Dangerous
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.
Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000
Stryker Medical Division of Stryker
🏥 Medical Devices Class I - Dangerous
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .