Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer cup.…
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the capacitor could…
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of…
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of…
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of…
The patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the manufacturing date (2024-04-01) as the expiration date. The actual expiration…
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly…
Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain…
The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the…
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of…
Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
The product was found to have Listeria monocytogenes
Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
Potential Listeria monocytogenes contamination
Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
Product may contain Foreign object: Glass
Browse recent months with enough recall history for useful comparison.
