🏥 Medical Devices Class I - Dangerous
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
All Recalls
95,075 total recalls in our database
🏥 Medical Devices Class I - Dangerous
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 along with the arm housing
🏥 Medical Devices Class I - Dangerous
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 background count.
🏥 Medical Devices Class I - Dangerous
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD
Arrow International
🏥 Medical Devices Class I - Dangerous
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
🏥 Medical Devices Class I - Dangerous
The infusion sets were manufactured with an incorrect spin collar.
🏥 Medical Devices Class I - Dangerous
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 Numbers 002, 003 and 004. Through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. As a result, it is possible that (1) the set screw drive feature will not accept the Set Screw Driver (PN: 79-1006) or (2) the driver may get wedged in the corners of the drive feature (false bottom) which may lead to a stripped set screw.
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.
🏥 Medical Devices Class I - Dangerous
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 as hematuria.
Arrow¿ Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB
Arrow International
🏥 Medical Devices Class I - Dangerous
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
🏥 Medical Devices Class I - Dangerous
"Chattering" when cutting burrs are used in bone.
BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.
Lifeline Systems Company
🏥 Medical Devices Class I - Dangerous
A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.
Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
Hamilton Medical AG
🏥 Medical Devices Class I - Dangerous
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.
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
Arrow International
🏥 Medical Devices Class I - Dangerous
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
🏥 Medical Devices Class I - Dangerous
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 mis-identification.