Hazard
25 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 25 labeling deficiency recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (8%) are Severe.
Which agencies issued them
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all labeling deficiency recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.
A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.
Manik and Apex-branded ATX computer power supplies are recalled because they lack a permanent on-product label warning of shock and electrocution hazards if the unit is opened.
Defibtech is recalling Automated External Defibrillators Model DDU-2300 distributed in Switzerland because Italian-language labeling and instructions were not included, violating Swiss Medical Devices Ordinance requirements.
Zimmer, Inc. is recalling a ceramic hip prosthesis head because the product labeling does not adequately describe compatibility with certain femoral stems used in hip replacement surgery.
CareFusion is updating labeling for BD PYXIS medication management cabinets to add a contraindication statement prohibiting use in procedure and operating rooms.
CareFusion is updating labeling for BD PYXIS MEDBANK medication systems to include a contraindication against use in procedure and operating rooms. Healthcare facilities should review updated labeling and ensure appropriate device placement.
Abiomed is updating labeling for the Impella 5.5 SmartAssist S2 cardiac assist device to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions.
The FDA is recalling Impella CP Smart Assist Sets due to a potential device interaction with Shockwave Coronary IVL Catheters used during coronary interventions. Abiomed will update device labeling to inform users about this interaction.
Abiomed is recalling the Impella CP Pump 371 Set due to a potential device interaction with the Shockwave Coronary IVL Catheter. The manufacturer is updating labeling to address this interaction. No illnesses or injuries have been reported.
Abiomed recalled 413 units of Impella 5.5 with SmartAssist S2 pumps worldwide due to a potential undocumented interaction with Shockwave coronary catheters during cardiac procedures. The company will update product labeling to disclose this interaction.
Abiomed is updating labeling for Impella CP Smart Assist pumps to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. The interaction was previously undocumented in device labeling.
Abiomed is updating labeling for Impella 5.5 with SmartAssist Set due to a potential device interaction with Shockwave Coronary IVL Catheter during coronary interventions. The product labeling currently lacks information about this potential interaction.
Beyond Baby Vibe Bear-branded playyard mattresses sold on Amazon.com from January to June 2023 are recalled due to suffocation hazards for infants. The mattresses violate federal crib mattress safety standards for firmness, thickness, warnings, and labels.
DeVilbiss Healthcare is updating the instruction manual for its 1025 Series Oxygen Concentrator to comply with IEC-60101-1 standard labeling requirements. This recall affects 143,397 units distributed nationwide and worldwide.
Epic Baking is recalling Cafe' Intermezzo White Chocolate Raspberry Cheesecake because sub-ingredients were not listed on the product label, though major allergens were properly disclosed.
BD recalls CareFusion bipolar forceps (Ref F-5301) due to incomplete Instructions For Use. The IFU is missing information about power supply interface and cleaning and maintenance.
Volcano Corp is recalling Visions PV. 035 Digital IVUS Catheters because instructions for use do not include contraindications information. Healthcare providers should contact the manufacturer for complete safety documentation before use.
IntraSight Mobile IVUS Systems touch screen modules lack required labeling information including device identifier and manufacturer information. Affected units were distributed to healthcare facilities in the US and internationally.
Cook Medical is recalling Celect Platinum Vena Cava Filter Sets due to revisions needed in the instructions for use, including updates to contraindications, warnings, precautions, and potential adverse events.
CardioQuip is recalling 1,478 Modular Cooler-Heater devices because the labeling does not include proper water-quality maintenance and device inspection guidance.
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance device instructions for proper use.
Covidien, LP is voluntarily withdrawing the Palindrome RT Repair Kit to implement improved point-of-use labeling and enhance the Instructions for Use. This affects Item Code 8888541133 (Lot Number 1705400292) distributed worldwide.
Covidien, LP is voluntarily withdrawing Palindrome RT Repair Kit 15 FR to implement point-of-use labeling and enhance Instructions for Use.
Xellia Pharmaceuticals USA is recalling Micafungin for Injection 50 mg/vial due to an incomplete package insert that omits required sections on Adverse Reactions, Drug Interactions, and Use in Specific Populations.
Villa Radiology Systems LLC is recalling 66 Apollo EZ multi-function x-ray systems because a chain of faults caused an injury to a user.
Villa Radiology Systems LLC is recalling Juno DRF x-ray systems after an injury occurred due to a chain of faults involving physical barriers and labeling.