All recalls8,424 total
Products may be contaminated with Listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
Due to off-the-shelf display port component that has audio/video failures
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Product may contain metal fragments.
Potential physical contamination: dark spot was noticed on the bottom of container.
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
Due to manufacturing issues, reperfusion catheters may fractures
Improperly eviscerated which may result in Clostridium botulinum contamination
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
Incorrect product formulation: bag did not contain copper and famotidine per label.
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
Presence of foreign substance
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
Undeclared sodium tripolyphosphate (STTP)
Undeclared sodium tripolyphosphate (STTP)
Undeclared sodium tripolyphosphate (STTP)
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Microbial Contamination of Non-Sterile Products
Labeling: Incorrect or Missing Lot and/or Exp Date
Product contaminated with Listeria monocytogenes.
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.
Product contaminated with Listeria monocytogenes.