147 recalls tagged with “mandatory standard violation”.
Generic magnetic ball sets sold on Amazon by Ritons are recalled after a high-risk ingestion hazard was identified. The magnets, 3 mm in size and packed in sets of 1,000, can cause serious injury or death if swallowed. Consumers should stop using the recalled product immediately and contact Ritons for a refund with a prepaid return label.
Bellabu Bear recalls its bamboo sherpa children's robes sold at Saks Fifth Avenue stores and online retailers from January 2024 through July 2025 for about $60. The robes do not meet mandatory flammability standards for children's sleepwear and pose a burn risk. Stop using the recalled robes and contact Bellabu Bear for a full refund or store credit.
Pivotal Health Solutions is recalling 34 Quantum Q400 intersegmental heated massage tables sold nationwide in the United States, Canada and Japan. The recall cites heat-function components that can be damaged over time when pressed, risking overheating, smoldering and melting of the vinyl cushion. Clinicians and patients should stop using the device immediately and await manufacturer instructions.
Blossom recalled two-piece children’s loungewear sets sold under its brand due to a burn risk that violates the mandatory flammability standard for children's sleepwear. The recall covers sets in multiple colors and designs sold for sizes 12 months through 12 years. Stop using the garments and contact Blossom for a full refund.
Wegmans Food Markets is recalling 521 units of Wegmans Large Ultimate Plain Cheesecake sold in Virginia, Maryland, North Carolina and Washington D.C. The product contains undeclared pecans. Consumers should stop using the product and contact Wegmans for refund or replacement.
Synthes (USA) Products LLC recalled 120 low-profile locking screws for intramedullary nails used in the RFN-Advanced Retrograde Femoral Nailing System and the Tibial Nail Advanced System. The recall covers devices distributed worldwide through healthcare providers. The external packaging mislabels screw lengths: 42 mm screws are labeled 46 mm and 46 mm screws are labeled 42 mm. Hospitals and spine
Mad Rabbit recalls RELIEVE lidocaine numbing cream due to non‑compliant packaging that could allow poisoning of young children. The recall covers a product sold under the Mad Rabbit brand and issued on 2025-09-25. The packaging does not meet the Poison Prevention Packaging Act requirement for child resistance. Consumers should stop using the product immediately and contact Mad Rabbit for a free, a
BD MAX System recall affects 62 units distributed worldwide in 2025 after unauthorized access to service credentials. An unauthorized actor accessed credentials used by BD technical support teams. Healthcare providers should stop using the devices and follow the manufacturer’s recall instructions.
Kico Knee Innovation recalls 21 ARVIS Shoulder systems nationwide after reports that AI planning software may cause implant malalignment or reduced range of motion. The recall covers software version V2025.1.2 used with IN-27300 hardware. Healthcare providers and patients should stop using the device and follow manufacturer instructions.
Ascend Laboratories recalls Alkem Atorvastatin Calcium Tablets USP 20 mg for dissolution failures in 2025. Distributed by Ascend Laboratories, Parsippany, NJ, nationwide. The issue: dissolution specifications not met. Stop use immediately and follow recall instructions. Check your NDC numbers to identify affected lots.
GE Medical Systems recalled 37 LOGIQ P9 R4.5 ultrasound systems sold nationwide in the United States and globally after regulators flagged UGAP measurements that may misrepresent liver steatosis. The UGAP data may display inaccurate values representing liver steatosis, potentially guiding inappropriate clinical decisions. Clinicians should stop using the affected devices and await recall guidance.
B BRAUN MEDICAL INC recalls 5,770 PERIFIX FX Epidural Anesthesia Trays nationwide after a potential lid misalignment in the catheter connector. The issue could affect catheter administration. Stop using the device and follow recall instructions immediately. Healthcare providers should contact B Braun for guidance.
B Braun Medical recalled an epidural anesthesia tray nationwide after finding a lid misalignment in the catheter connector could occur. The recall involves the PERIFIX FX Continuous Epidural Anesthesia Tray and PERIFIX FX Springwound Catheter with a 17 Ga Tuohy needle and 19 Ga closed-tip catheter. The recall date is 2025-09-18 with report of ongoing action as of 2025-10-15. Healthcare providers,,
GE Medical Systems Israel recalls 11 Elscint Cardial dual-head gamma cameras used for cardiac imaging worldwide. The recall concerns detector mounting that could fail if the unit is moved without proper support. Hospitals should stop using these devices immediately and follow GE’s recall instructions.
In My Jammers recalls children's button-up flare pajama sets sold online after the company violated mandatory flammability standards. The recall, active as of Sept. 11, 2025, involves sets in multiple prints and sizes. Parents should stop using them and seek a full refund or store credit.
Olympus recalled 3,216 BF-1T60 bronchofiberscopes distributed nationwide and internationally after updating instructions for safe use with laser, argon plasma coagulation and high-frequency therapy equipment. The recall updates guidance to reduce risk during advanced energy-device procedures. Clinicians and facilities should stop using the devices and follow manufacturer instructions for recall.
Beckman Coulter recalled three boxes of MicroScan Neg Multidrug Resistant MIC 1 panels distributed internationally, including Poland. A manufacturing issue caused incorrect processing in in vitro multidrug resistance testing. Healthcare providers and patients should stop using the device immediately and follow manufacturer instructions for recall communications.
American Contract Systems recalled 32,433 medical convenience kits sold through multiple retailers nationwide. The devices were re-gassed after a nonconformance in the Ethylene Oxide gas injection process and have not been validated for exposure to multiple sterilization cycles. Healthcare providers and patients should stop using these products immediately and follow the manufacturer's recall.
Zydus Lifesciences Ltd. recalled Chlorpromazine Hydrochloride tablets, 25 mg, 100-count bottles distributed nationwide by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. The recall cites CGMP deviations and the presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. Stop using the product and contact your healthcare provider or Zydus Pharmaceuticals (USA) Inc. for
Siemens Medical Solutions USA recalls 18 MAGNETOM Skyra Fit BioMatrix MRI systems worldwide due to ice blockage in the magnet venting system that could trap helium gas during a quench. The risk is a ruptured helium containment and a potential helium leak into the scanning room. Hospitals and clinicians should stop using the affected devices and await manufacturer instructions.