Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Mesa Laboratories is recalling SporAmpule Biological Indicators because the concentration of bromocresol purple does not conform to specification.
Quidel is recalling 482 Sofia 2 Analyzers because a manufacturing error may cause calibration failure or incorrect test results.
Biomet is recalling 634 Zimmer Biomet Comprehensive Segmental Revision System implants because a screw hole mismatch may prevent proper assembly during surgery.
SIE AG is recalling 125 FEMTO LDV Z8 femtosecond surgical lasers worldwide due to usability and performance improvements identified after a cataract procedure complication.
Johnson & Johnson Vision Care is recalling specific lots of ACUVUE OASYS contact lenses because foreign matter was found between the blister package and foil.
Johnson & Johnson Vision Care is recalling 1-DAY ACUVUE Moist for Astigmatism contact lenses due to reports of foreign matter found between the blister package and foil.
Medical Components, Inc. is recalling 8F Plastic Dignity Low Profile CT Port kits because they were packaged with unmarked guidewires instead of the marked ones indicated on the label.
Mesa Laboratories is recalling specific lots of ProSpore Biological Indicators because the concentration of bromocresol purple does not conform to specification.
Paddock Laboratories is recalling 52,596 bottles of Evamist (estradiol) transdermal spray because cracks in the vial neck may cause product evaporation, leaking, or dispensing failure.
Zimmer Dental Inc is recalling Tapered Screw-Vent MTX dental implants because two lots with different thread diameters were commingled and may be mislabeled.
Zimmer Biomet is recalling nine Coonrad/Morrey Elbow Implant humeral assemblies because they are missing required humeral bushing components.
Roche Diagnostics is recalling Modular E 170 Analyzers because using 13 mm sample tubes without adapters may cause questionable test results.
Johnson & Johnson is voluntarily recalling select first aid wraps because the 'not made with natural rubber latex' label is inaccurate.
Zimmer Dental Inc is recalling Tapered Screw-Vent MTX dental implants because two lots were inadvertently commingled during manufacturing, potentially resulting in mislabeling.
Johnson & Johnson is recalling select first aid wraps because they were labeled as latex-free but used natural latex in early manufacturing.
GE Healthcare is recalling two Datex-Ohmeda AISYS CS2 Aladin2 cassettes because they were shipped without proper evaluation and may be nonconforming.
Zimmer Biomet is recalling 3 units of the Persona Knee System because the set screw and taper plug were missing from the packaging.
Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required clinical procedure notes and checklists.
Centurion Medical Products Corporation is recalling St. Christopher's Securement Sets because the PVP Prep Pad does not meet required iodine assay levels for shelf life.
Arrow International is recalling 18,124 percutaneous sheath introducer kits because they lack required central line insertion checklists and procedure notes.
Centurion Medical Products is recalling Neonatal IV Access Sets because the PVP Prep Pad does not meet required iodine levels for shelf life.
Centurion Medical Products is recalling suture removal kits because the included PVP prep pads do not meet required iodine levels for their 36-month shelf life.
Teva Pharmaceuticals is recalling Estradiol Vaginal Inserts because patients reported difficulty dispensing the tablet from the applicator.
Epigenomics Ag is recalling 200 units of the Epi proColon Plasma Quick Kit because the diagnostic test may produce invalid runs, potentially delaying results.
CooperSurgical is recalling 13 units of 2 MHz Waterproof OB probes because they were incorrectly labeled as 3 MHz probes.