Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
27,577 detailed records are currently available in this category.
Users manuals not supplied with 4800-00T US Rapid Therapy System
Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters.
Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the…
Firm is recalling first aid/emergency kits and cabinets which contain Honeywell Eyewash (3 lots) which is being recalled due to leaking bottles.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Product has been found with a missing Washer, Retaining Ring, and/or Stop Screw. Recalling firm was notified by distributor that Refractor Suspension Arm fell on a patient s lower torso…
Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzer may cause the system to produce an elevated platelet…
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
The infusion sets were manufactured with an incorrect spin collar.
Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot…
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
The infusion sets were manufactured with an incorrect spin collar.
BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such…
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.
After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.
The infusion sets were manufactured with an incorrect spin collar.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the…
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct…
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
