95,018 total recalls in our database
Penner Patient Care
The device does not bear a unique device identifier.
Waldemar Link GmbH & Co. KG (Mfg Site)
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Penner Patient Care
The device does not bear a unique device identifier.
Instrumentation Laboratory
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Penner Patient Care
The device does not bear a unique device identifier.
Product not cleared by the FDA.
Becton Dickinson & Company
During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
Products contain undeclared milk and soy.
Potential contamination with patulin.
Products contain undeclared milk and soy.
Italianway Import
Potential contamination with foreign material (Teflon fragments) from flaking cooking molds.
Karns Prime And Fancy Foods
Product may contain undeclared peanuts.
Bader Enterprises
Contains undeclared allergen (wheat) and colors (FD&C Blue 1 Lake and FD&C Blue 2 Lake).
Undeclared shrimp, crab, lobster, pollock (fish), whiting (fish), and soy.
Bader Enterprises
Contains undeclared colors (FD&C Blue 1 Lake and FD&C Blue 2 Lake).
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
CGMP Deviations
CGMP Deviations
The Harvard Drug Group
Defective container; inadequately sealed blister packaging.
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution