95,038 total recalls in our database
Leventon S. A. U.
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
Roche Diagnostics Operations
Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.
Siemens Medical Solutions USA
The injector holder could potentially fall off together with the injector and the storage box.
Bard Peripheral Vascular
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Bard Peripheral Vascular
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Bard Peripheral Vascular
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Baxter Healthcare
EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.
The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited and could lead to serious health consequences, such as skin burns. some products do not contain the updated IFU.
Bard Peripheral Vascular
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Medline Industries
Samples in the identified lot were found to have incomplete or open packaging seals.
Bard Peripheral Vascular
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Bard Peripheral Vascular
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The seal integrity of the sterile bag containing the kits may be compromised.
The seal integrity of the sterile bag containing the kits may be compromised.
Bausch & Lomb Inc Irb
Possible dull knife edge
Siemens Medical Solutions USA
The injector holder could potentially fall off together with the injector and the storage box.
Bard Peripheral Vascular
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The seal integrity of the sterile bag containing the kits may be compromised.
Karl Storz Endoscopy
The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.
DRG Instruments GmbH
Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producing a significantly lower result.