Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
API 20 E 25 STRIPS, CATALOG 20100
Biomerieux
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01
ENDO Pharmaceuticals Solutions
Class I - Dangerous
No expiration dates printed on the packaging
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
Biomerieux
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
Remington Medical
Class I - Dangerous
The stylet is longer than specified on the label
Pilling Wecksorb Cylindrical Sponges
TELEFLEX
Class I - Dangerous
Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.
Distribution without Pre-Market Clearance
Distribution without Pre-Market Clearance
Distribution without Pre-Market Clearance
Distribution without Pre-Market Clearance
Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
Young Dental Manufacturing I
Class I - Dangerous
mislabeled product
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Baxter Healthcare
Class I - Dangerous
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Class I - Dangerous
During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm.