FDA Medical Device Recalls & Safety Alerts (CDRH MedWatch) Regulatory Safety

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Real-time alerts on Class I, II, and III medical device recalls, urgent safety advisories, packaging sterility failures, biomaterial contamination, and hardware fracture/taper corrosion notices. Attendings & Fellows: Critical for patient safety to avoid implanting recalled components (e.g., liner dissociation, trunnion corrosion, sterile barrier breaches) and protect against institutional liability.

• Breathing Circuit Recall: Draeger Removes VentStar Resus Neo Hoses

  Removal of VentStar Resus Neo hoses due to the potential for cracks resulting in restricted ventilation or delayed therapy.

• Greenwich Rx Issues Voluntary Nationwide Recall of Compounded Glutathione Due to Elevated Endotoxin Levels

  IMMEDIATE RELEASE - Tomball, Texas – October 1, 2026 – Greenwich Rx, a 503A compounding pharmacy, is voluntarily recalling specific lots of its compounded glutathione to the consumer level. The product is being recalled due to potential elevated endotoxin levels.

• Angiographic Catheter Recall: Boston Scientific Removes Imager II Angiographic Catheters

  Boston Scientific Imager II Angiographic Catheters removed due to a manufacturing issue leading to tip detachment; could result in procedural delays, embolism

• Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers

  Abiomed is removing Automated Impella Controllers due to purge cassette recognition failures that may lead to prolonged delayed in mechanical circulatory support.

• Convenience Kit Correction: Becton Dickinson Issues Correction for Kits and Procedure Trays Containing Recalled Sodium Chloride Ampules

  BD is correcting convenience kits and procedural trays containing recalled Huons Co. sodium chloride ampules

• Early Alert: Heart Pump Controller Issue from Abiomed

  Abiomed is removing certain Impella Controllers with various hardware, firmware, and/or software updates based on a retrospective review of servicing records.

• Early Alert: Ventilator Issue from React Health

  IFT cable connector on VOCSN devices may become unseated and lose communication with internal flow transducer board leading to reboots, System Fault 10 Alarms.

• Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP Due To a Product Mix-up with 10 mEq Potassium Chloride Injection

  Otsuka ICU Medical LLC is issuing a voluntary recall for one lot of 0.9% SODIUM CHLORIDE Injection, USP, 100mL single pack to the user level due to a potential mix-up. The affected lot of 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984-23 Lot 1042188) may potentially contain the overwrap with la

• Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter

  ROCHESTER, MI– September 18, 2026 –Par Health is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) to the hospital level. The product is being recalled due to the presence of particulate matter identified as cellulose or stopper materia

• Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Huons Sodium Chloride Ampules

  AVID Medical is correcting convenience kits containing recalled Huons Co. sodium chloride ampules.