370 recalls tagged with “nhtsa regulated”.
ACME United Corporation recalls Med Nap Cleansing Towelettes, 5"x7" Benzalkonium Chloride 0.13%, distributed nationwide. CGMP Deviations prompted the recall. Stop using the product now and contact ACME United or a healthcare provider for guidance.
Nationwide recall of Dukal BZK Antiseptic Towelettes due to CGMP deviations. The products are manufactured for Dukal, LLC in Ronkonkoma, NY and distributed across the United States. Stop using immediately and contact ACME United Corporation for guidance.
Acme United Corporation recalled Med Nap BZK Antiseptic Towelettes, 100-count, distributed nationwide. The FDA-listed CGMP deviations raise concerns about manufacturing quality and product safety. Consumers and healthcare providers should stop using the product and follow the recall letter for guidance.
Instrumentation Laboratory recalled 1,225 GEM Premier 5000 PAK cartridges worldwide on 2026-01-20 after concerns of PCSND errors during warm-up. The errors can trigger GEM PAK cartridge ejection and may require insertion of a new PAK, delaying results. Stop using the device immediately and follow the manufacturer’s recall instructions.
ACME United recalled WP WipesPlus Hand Sanitizing Wipes, 100-count, sold nationwide, after CGMP deviations were identified. The recall is classified as Class II. Consumers should stop using the product immediately and await guidance from ACME United. The NDC is 67151-727-01.
Instrumentation Laboratory recalls 489 GEM Premier 5000 PAK cartridges worldwide after reports of Process Control Solution Not Detected errors during warm-up. iQM2 monitors the testing process and may allow continued use after AutoPAK Validation. The recall highlights potential operational disruptions in patient management.
Dynarex recalled 1,000-pack BZK Antiseptic Towelettes nationwide after CGMP Deviations were identified. The product contains benzalkonium chloride 0.13% and carries NDC 67777-245-04. Consumers should stop using this product immediately and await recall notification by letter.
First Aid Only BZK Antiseptic Towelettes are recalled nationwide in 2026 after CGMP Deviations were identified at the Acme United Corporation facility. The recall cites CGMP Deviations that could affect product quality. Consumers should stop using the product and contact Acme United Corporation for guidance.
Instrumentation Laboratory issued a high-severity recall for 1,126 GEM PAK cartridges used with the GEM Premier 5000. The recall cites increased PCSND errors during warm-up that can cause consecutive GEM PAK ejections. The issue may delay patient results. Hospitals should halt use and follow manufacturer instructions immediately.
Dynarex Obstetrical Towelettes Cleanser is under an active FDA recall as of Jan. 20, 2026. The recall cites CGMP Deviations that could affect product quality. Consumers and healthcare providers should stop using the product immediately and contact ACME United Corporation or a healthcare provider for guidance.
GEM Premier 5000 recall announced for 1,989 units distributed worldwide, including the US and numerous other countries. The issue involves GEM PAK cartridges experiencing Process Control Solution Not Detected errors during warm-up, causing ejections and potential delays in patient results. Stop using the device and follow manufacturer recall instructions.
Instrumentation Laboratory recalls 352 GEM PAK cartridges for the GEM Premier 5000 worldwide due to increased PCSND errors during warm-up, risking delayed results. Medical facilities should stop using affected GEM PAKs and follow recall instructions. Manufacturers will provide further guidance to healthcare providers and patients.
ACME United Corporation is recalling Savannah Antibacterial Towelettes nationwide after CGMP deviations in manufacturing. The deviations may affect product quality and safety. Stop using the product immediately and contact ACME United or your healthcare provider for guidance.
ACME United Corporation recalled 212,607,900 First Aid Only BZK Antiseptic Towelettes sold nationwide. The recall cites CGMP deviations in manufacturing. Consumers should stop using the product immediately and contact ACME United Corporation for guidance.
ACME United Corporation recalled BZK Antiseptic Towelettes sold for Food Service Resources nationwide after CGMP deviations were found. The recall is Class II and high risk. Consumers and healthcare providers should stop using this product immediately and follow recall guidance.
Bader Enterprises recalls 60 pounds of Premium Food Jordan Almonds sold in New Jersey and New York. The product contains undeclared wheat and blue color additives. Consumers who purchased the product should not consume it. Contact Bader Enterprises for refund or replacement information via two or more notification methods.
GE Healthcare recalled 250 Centricity Universal Viewer Zero Footprint Client units distributed worldwide after finding a risk that patient information may not match displayed images in certain workflows. The issue affects ZFP v6.0 SP11.6, SP11.6.0.1 and SP11.6.1 when Patient Timeline is installed. Hospitals should stop using affected units and await instructions from GE Healthcare.
Olympus Corporation recalled 744 High Flow Insufflation Units on January 16, 2026. A software algorithm issue may lead to overpressure events during use. Patients and healthcare providers must stop using the device immediately.
Aesculap recalls 126 MINOP TROCAR 150MM devices distributed nationwide to U.S. hospitals and clinics after regulators flagged a shaft length issue. The shaft may be longer than specified, potentially harming tissue during procedures. Healthcare facilities should stop using the devices and follow manufacturer recall instructions immediately.
Waldemar Link recalled 1 unit of Endo-Model Replacement Plateau worldwide, including the United States in New Jersey. The device could detach its bushing from the screw shaft because of a longitudinal fracture. Clinicians and patients should stop using the device and await manufacturer instructions.