Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
Esaote is recalling Endocavity ultrasonic probes (Model E 3-12) due to a potential weakness that may cause liquid leakage from the cable terminal area. Five units distributed in North Carolina and Texas are affected.
Staar Surgical is recalling 7 EVO+ Visian Toric Collamer Lenses (Model VTICM5) that were labeled as 12.1 mm but are actually 12.6 mm. The oversized lenses may cause excessive vault, leading to angle closure and elevated intraocular pressure requiring lens exchange.
Aesculap Inc. is recalling 126 units of its MINOP TROCAR 150MM surgical instrument (Model FF399R) because the trocar shaft may be longer than specification. The affected units were distributed to healthcare facilities nationwide.
Diagnostica Stago is recalling STA Liatest Free Protein S diagnostic kits that may produce inaccurate test results, underestimating free protein S levels in patient plasma samples.
B. Braun is recalling 21,000 units of its 21GA WINGED INFUSION needle due to the potential for needle tips to be dull, blunt, or break during use. The defect affects subcutaneous implant procedures.
Olympus is recalling 602 ShockPulse-SE Lithotripsy Systems due to generator malfunction caused by connector damage. The generator may fail to recognize the transducer, preventing proper device operation during stone fragmentation procedures.
Acme United Corporation is recalling BZK Pads (Benzalkonium Chloride 0.13%) obstetrical towelettes nationwide due to manufacturing process deviations. No illnesses or injuries have been reported.
Children's Healthcare of Atlanta hand sanitizing wipes are recalled due to manufacturing practice deviations. Affected lots were distributed nationwide; no illnesses have been reported.
Med-Nap Cleansing Towelettes containing benzalkonium chloride are being recalled nationwide by Acme United Corporation due to Current Good Manufacturing Practice (CGMP) deviations.
Datascope Corp. is updating battery runtime and cycle specifications in the CS300 IABP Instructions for Use. No illnesses or injuries reported.
Bader Enterprises, Inc. has recalled Premium Food Bubble Gum (2.5 oz packages) because it contains undeclared food colors FD&C Blue 1 Lake and FD&C Blue 2 Lake. The product was distributed in New Jersey and New York.
ACME United Corporation has voluntarily recalled MED NAP Cleansing Towelettes distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. No illnesses or injuries have been reported.
ACME United Corporation is voluntarily recalling First Aid Only BZK Antiseptic Towelettes nationwide due to manufacturing process deviations. The recall affects multiple lot numbers with expiration dates through December 2028.
ACME UNITED CORPORATION is recalling multiple brands of BZK Antiseptic Towelettes nationwide due to manufacturing compliance deviations. The firm initiated this voluntary recall on January 20, 2026.
ACME United Corporation is recalling BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) due to manufacturing process deviations. The voluntary recall affects lots 53518 and 53519 distributed nationwide.
Olympus ShockPulse-SE lithotripsy system generators have a mis-wired component causing electrical noise that violates electromagnetic compatibility standards. This may reduce system reliability and delay kidney stone treatment. 55 units affected in Canada, Germany, Singapore, Australia, and India.
Advanced Bionics is recalling 2 units of the Sky CI M90 Sound Processor due to a packaging label that does not match the product inside. Users should verify device specifications before use.
ACME UNITED CORPORATION is recalling Savannah Antibacterial Towelettes nationwide due to Good Manufacturing Practice deviations. No illnesses have been reported.
Medi-First Antiseptic Wipes containing benzalkonium chloride have been recalled nationwide due to manufacturing deviations. The voluntary recall affects multiple lot numbers with expiration dates through August 2028.
Acme United Corporation is voluntarily recalling Med-Nap Benzalkonium Chloride Antiseptic Towelettes nationwide due to manufacturing quality deviations. The recall affects multiple lot numbers with expiration dates through October 2028.
ACME United Corporation is recalling BZK Antiseptic Towelettes nationwide due to Current Good Manufacturing Practice (CGMP) violations. The firm initiated this voluntary recall to address manufacturing process deviations.
Green Guard Antiseptic Wipes are being recalled due to manufacturing quality deviations. The firm initiated the recall voluntarily.
ACME United Corporation is recalling First Aid Only BZK Antiseptic Towelettes nationwide due to manufacturing practice deviations. The firm initiated this voluntary recall to address quality control issues.
ACME UNITED CORPORATION is voluntarily recalling Antimicrobial Alcohol Hand Wipes nationwide due to manufacturing practice deviations. The company initiated this recall in January 2026.
Olympus is recalling the ShockPulse-SE Lithotripsy System generator because damage to the transducer plug or generator receptacle may cause the device to remain in a blinking state and fail to recognize the transducer. The 1,684 affected units were distributed worldwide.