689 recalls tagged with “fda regulated”.
Philips Respironics recalls 113,717 Trilogy Evo O2 home-use ventilators in 2026. The Obstruction Alarm may fail to trigger within required standards, delaying warning for airway obstruction for up to four breaths. Stop using the device and follow recall instructions from Philips or your clinician.
Civco Medical Instruments Co. recalled 21 eTRAX Needle Sensors for Aurora Trackers sold to healthcare providers in Ohio, Pennsylvania and Washington. The devices have an inspection and programming error that can cause the needle tip position to be misidentified on the user interface. Clinicians should stop using the devices immediately and follow recall instructions from Civco.
Civco Medical Instruments recalled 20 eTRAX Needle System Starter Kit 18G for Aurora Trackers. An error in inspection and programming of the needle sensor can cause needle tip position to be misidentified on the user interface. Healthcare providers and facilities should stop using the device immediately and follow the recall instructions from the manufacturer.
Five Civco Medical Instruments eTRAX Needle Sensor 12G units for Aurora Trackers are recalled in the United States. The recall cites an inspection and programming error that could misidentify the needle tip position on the user interface. Healthcare providers should stop using the device immediately and follow recall instructions.
Olympus recalls 408 SOLTIVE Premium Laser System units worldwide after a defect in the 24V power supply may render the system inoperable and cause smoke or a burning smell. The issue is contained within the internal console and would self-extinguish. Hospitals should stop using the device immediately and follow recall instructions.
Macleods Pharma USA, Inc. recalls 1,315 bottles of Levothyroxine Sodium Tablets USP 150 mcg distributed nationwide. The drug is subpotent, which may not provide the full therapeutic dose. Stop using and contact your healthcare provider or Macleods Pharma USA, Inc. for guidance.
American Laboratories recalled 468 kg of Pepsin 1:3000 Powder distributed through 11 wholesale accounts in the United States and one in Australia. The powder is potentially contaminated with Salmonella and could cause illness if used. Consumers who purchased this product should not consume it and should contact American Laboratories by email for refund or replacement.
American Laboratories recalled 370 kg of Pepsin 1:10,000 Powder sold through 11 wholesale accounts in AZ, CA, FL, MO, NM, OH, SC, UT, WI and one account in Australia after a potential Salmonella contamination. The product carries a possible Salmonella contamination risk. Consumers should not consume the product and should contact American Laboratories for refund or replacement via email.
American Laboratories recalled 400 kg of Pepsin Full Strength Powder sold to 11 direct wholesale accounts in AZ, CA, FL, MO, NM, OH, SC, UT, WI and one wholesale account in Australia after a recall cited potential Salmonella contamination. The product is Item #5000545 and packed in double poly-lined drums or boxes. Consumers should not consume this product and should contact American Laboratories,
Gooder Foods recalled 61,176 cartons of pasta on September 10, 2025, due to undeclared allergens. The product may contain cashews, posing a risk to consumers with nut allergies. The affected lots were distributed across multiple states in the U.S. and Canada.
Synthes bone taps recalled nationwide in the United States after a lot swap affected 33 units sold through multiple retailers. The defect is an incorrect thread caused by a lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8. Healthcare providers should stop using these devices immediately and follow recall instructions from Synthes.
Olympus Corporation of the Americas is recalling 106 Everest Bipolar Cutting Forceps worldwide. The devices can have welding defects that may cause the jaw to break during use. Stop using immediately and contact Olympus or your healthcare provider for instructions.
Olympus Corporation of the Americas is recalling 2,648 HALO PKS Cutting Forceps HACF0533 sold to hospitals and clinics worldwide. The jaw can break during surgical use due to a supplier welding-validation issue. Healthcare facilities should stop using the device immediately and follow Olympus recall instructions for disposition.
Olympus Corporation of the Americas recalled 326 PKS Cutting Forceps worldwide. The devices may have welding defects that cause the jaw to break during use. Stop using the device immediately and follow the recall instructions provided by Olympus.
Olympus Corporation of the Americas recalled 164 Everest Bipolar Cutting Forceps worldwide on Feb. 25, 2026. A supplier welding process was not adequately validated, risking jaw breakage during surgical use. Clinicians should stop using the device and follow Olympus recall instructions.
Olympus Corporation of the Americas is recalling 444 PK-CF0533 cutting forceps distributed worldwide. The devices may have welding defects that can cause the jaw to break during surgery. Stop using the device and follow recall instructions from Olympus or your healthcare provider.
Imu-Tek Animal Health recalled 64 bottles of Colostrum-5 Powder sold through multiple retailers. The recall covers products distributed in 29 states. The product is potentially under-processed. Consumers should stop using it and contact Imu-Tek Animal Health for refund or replacement.
King Harvest Balsamic Hummus recalled by Pacific Coast Fresh Co. The product was distributed in Oregon and Washington. A foreign material aluminum piece hazard was identified. Consumers should not eat the product and should contact Pacific Coast Fresh Co for refund or replacement information by telephone.
King Harvest Roasted Red Pepper Hummus, distributed in Oregon and Washington by Pacific Coast Fresh Co, is recalled. The recall cites foreign material aluminum pieces found in 10 oz and 17 oz tubs. Consumers should not eat the product and should contact Pacific Coast Fresh Co for a refund or replacement.
Pacific Coast Fresh CO recalls 348 10-ounce King Harvest Sundried Tomato Hummus containers sold in Oregon and Washington after aluminum pieces were found. The hazard is foreign material aluminum pieces in the hummus. Consumers should not consume the product and should contact Pacific Coast Fresh CO by telephone for refund or replacement.