1,319 recalls tagged with “fda regulated”.
Medline Industries recalled 31,848 dialysis dressing change kits on January 8, 2026. The recall follows reports of defective silicone seals on Tego Connectors that may occlude fluid paths. This defect can delay therapy and expose patients to biological contaminants.
Medline recalled 27,320 convenience kits on January 7, 2026, due to calibration issues with sterilization equipment. These defects may compromise the sterility assurance level of the products. Healthcare providers and patients should stop using the affected kits immediately.
Medline Industries recalled 7,725 surgical kits on January 7, 2026, due to potential sterility issues. Calibration problems with sterilization equipment may compromise the sterility assurance level. Healthcare providers and patients should stop using these kits immediately.
Olympus Corporation of the Americas recalled 3,954 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall occurred due to devices that may not have undergone proper thermoforming, risking deformation and loss of performance. Healthcare providers and patients should stop using the devices immediately and follow the recall instructions.
Medline Industries recalled 12,418 surgical kits on January 7, 2026, after identifying calibration issues in sterilization equipment. The defects could compromise sterility assurance levels of the devices. Healthcare providers and patients must stop using the affected products immediately.
Medline Industries recalled 4,415 surgical kits on January 7, 2026, due to sterilization calibration issues. These issues could compromise the sterility assurance level of the products. Healthcare providers and patients must stop using the kits immediately.
Medline Industries recalled 291 units of burn care kits on January 7, 2026. Calibration issues with sterilization equipment may compromise product sterility. Users should stop using the affected products immediately.
Karison Foods & Snacks Inc. recalled 2,760 units of its Panjiri snack on January 6, 2026. The product contains milk, which is not declared on the label. This recall affects consumers in New York, New Jersey, and Virginia.
Encon Safety Products recalls AQ 120 GFEW Aquarion Preserved Cartridges sold nationwide through multiple retailers. The recall cites cGMP deviations in manufacturing. Stop using the product immediately and follow recall guidance from Encon Safety or your healthcare provider.
Encore Medical, LP recalled 49 units of the EMPOWR Acetabular System on January 5, 2026. Packaging errors may cause surgical delays, potentially affecting patient safety. Healthcare providers should stop using these devices immediately.
Cipla USA, Inc. is recalling 15,221 Lanreotide Acetate Injection syringes nationwide in the United States after detecting particulate matter. The defect is the presence of particulate matter in the injectable solution. Healthcare providers and patients should stop using the product immediately and contact Cipla USA for guidance.
AVID Medical recalled 1,500 units of the TRANSPORT BAG KIT on January 2, 2026. A seal issue with the Tyvek bag may compromise the sterility of the kit. The recall affects healthcare providers and patients in New Jersey.
Sun Pharmaceutical Industries is recalling 24,624 bottles of Fluocinolone Acetonide Topical Solution nationwide after out-of-spec impurity D was detected. The product is distributed by Taro Pharmaceuticals in the United States and labeled Rx-only. Consumers must stop using the product and consult a healthcare provider for guidance.
Gold Star Distribution is recalling TUMS Assorted 12-count products sold nationwide through various retailers after CGMP deviations linked to insanitary conditions and rodent exposure at the distribution center. The recall covers three SKUs: 1194A with expiry 05/27 and 1194C with expiry 03/27, plus the Assorted 12-count variant. Consumers should stop using the product immediately and contact Gold
Gold Star Distribution Inc. issued a nationwide recall of Colgate and Crest toothpaste on December 26, 2025 after inspectors found insanitary conditions and rodent exposure at its distribution center. The issue stems from CGMP deviations that could contaminate products. Consumers should stop using the affected toothpaste immediately and contact Gold Star Distribution for guidance.
NyQuil Cold & Flu 32-count 2-pack is being recalled by Gold Star Distribution in the United States. The recall cites CGMP deviations and insanitary conditions at the distribution center, including rodent exposure. Stop using the product and contact the distributor for guidance.
Gold Star Distribution recalls Aleve 60-count pain relievers distributed nationwide due to CGMP deviations and insanitary conditions at its distribution center. Rodent exposure and activity were reported at the facility. Consumers and healthcare providers should stop using the product immediately and contact Gold Star Distribution for guidance.
Gold Star Distribution recalls Swan White Clear Alcohol, 50% ABV, 16 oz, 12 count, nationwide. FDA enforcement cites CGMP deviations and insanitary distribution-center conditions including rodent exposure. Stop using the product now and contact the distributor or a healthcare provider for guidance.
Gold Star Distribution recalls 8oz Ice Gel 12-count sold nationwide after investigators found insanitary conditions at the distributor's facility. A CGMP deviation allowed rodent exposure at the distribution center. Consumers and healthcare providers should stop using this product immediately and await guidance from Gold Star Distribution.
Gold Star Distribution recalls EXCEDRIN 2'S DISP.- 30 CT distributed nationwide in the United States. The recall cites CGMP deviations due to insanitary conditions including rodent exposure at the distribution center. Consumers and healthcare providers should stop using the product immediately and await guidance from Gold Star Distribution.