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.
Basic Reset Inc. is recalling 339 bottles of Nuovi Firming Masque because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Basic Reset Inc. is recalling Biogenyx CBD Oil because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Zimmer Biomet is recalling 5,459,583 limb salvage arthroplasty devices because non-highly polished implants may adhere to the LDPE bag packaging.
Philips is recalling 1,167 Forte Gamma Camera Systems because a detector may fall unimpeded vertically to the end stops of its travel limit.
Ortho-Clinical Diagnostics is recalling VITROS K+ Slides because a mechanical failure may cause intermittent slide dispense issues.
Thermo Fisher Scientific is recalling Cardinal Health sterile specimen containers that may contain plastic shavings on threaded surfaces.
Zimmer Biomet is recalling specific periarticular plates because non-highly polished implants may adhere to the packaging bag.
Datascope Corp. is recalling seven low level output cables for intra-aortic balloon pumps because they were packaged with incorrect cables.
Zimmer Biomet is recalling various fixation systems and accessories because non-highly polished implants may adhere to the LDPE bag.
Zimmer Biomet is recalling NCB Proximal Lateral Tibia implants because non-highly polished devices may adhere to the packaging bag.
Randox Laboratories is recalling 17 Rheumatoid Factor Standard kits because assigned values over-recovered against reference material. The values have been adjusted to align with the reference standard.
Zimmer Biomet is recalling 5.4 million periarticular locking elbow plates because non-highly polished implants may adhere to the packaging bag.
Zimmer Biomet is recalling Cable-Ready Short and Long GTR implants because non-highly polished units may adhere to the LDPE bag.
Rastelli Bros. is recalling approximately 130,464 pounds of raw ground beef products that may contain plastic. The recall affects products shipped to five states.
OrthoPediatrics Corp is recalling 969 Child Nail Attachment Bolts because they may bind with the intramedullary nail, potentially delaying surgical procedures.
Mindray is recalling 14 Rosie4 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.
Taro Pharmaceuticals is recalling 639,325 bottles of Ibuprofen Oral Suspension USP because they may contain small particles of inert plastic material introduced during manufacturing.
Mylan Pharmaceuticals is recalling 4,272 bottles of Prasugrel 5 mg tablets because they failed to meet dissolution specifications.
Mindray is recalling 107 Accutorr 7 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.
Taro Pharmaceuticals is recalling specific lots of Children's Ibuprofen Oral Suspension because they may contain small particles of inert plastic introduced during manufacturing.
Apotex Inc. is recalling specific bottles of Atorvastatin Calcium 40 mg tablets because a single Pravastatin 40 mg tablet was found inside one bottle.
Medtronic is recalling CareLink SmartSync Device Manager units because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.
Implant Direct is recalling 107 Scan Adapter Assemblies due to incorrect assembly that may prevent clinicians from capturing implant positions, causing patient delays.
Synthes (USA) Products LLC is recalling six 3.5mm spinal screws that measure 4.0mm in diameter. The product was distributed to New Jersey.