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.
Orthofix Srl is recalling specific lots of Lower Limb Diaphyseal Sterile Kits because drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.
Orthofix Srl is recalling specific lots of 3.2 mm drill bits because a geometric detail does not match the intended design, potentially reducing cutting performance.
Orthofix Srl is recalling specific lots of 4.8 mm drill bits because a geometric detail does not match the intended design, potentially lowering cutting performance.
Orthofix Srl is recalling specific lots of Lower Limb Diaphyseal Sterile Kits because drill bits have a design defect that may reduce cutting performance.
Orthofix Srl is recalling specific lots of 4.8 mm drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.
Orthofix Srl is recalling specific batches of 2.7 mm drill bits because a geometrical detail does not match the intended design, which could result in lower cutting performance.
Synthes (USA) Products LLC is recalling nine trial spacers with T-handles because they were modified outside of the approved manufacturing process.
Smith & Nephew is recalling 116 LAG Screw 3.2mm Guide Pin Sleeves because a manufacturing error prevented the detent balls from fully compressing.
Orthofix Srl is recalling Ankle Transfix Pin Sterile Kits because drill bits have a design defect that may reduce cutting performance.
Orthofix Srl is recalling specific lots of 4.8 mm drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.
Orthofix Srl is recalling UE Xcaliber Ankle Complete Kits because drill bits have a design flaw that may reduce cutting performance.
Orthofix Srl is recalling specific lots of drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.
Tec Com GmbH is recalling five TECOTHERM NEO thermo-regulation systems due to faulty Peltier elements that may fail to maintain temperature control.
Randox Laboratories is recalling NEFA FA115 Lot 485343 because it is not meeting performance claims and should not be used for testing.
Tornier, Inc. is recalling 87,869 Aequalis Ascend Flex Humeral Stems because movement during shipping may cause PETG material from the packaging to transfer to the device.
TriMed Inc. is recalling 467 Hex Drivers because the epoxy coating may pop off. The recall covers units distributed nationwide and to several foreign countries.
TriMed Inc. is recalling 99 nonsterile 1.7mm countersink instruments because the epoxy coating can pop off. The recall covers nationwide and specific foreign distribution.
Orthofix Srl is recalling specific lots of Ankle Sterile Kits because the drill bits have a design defect that may reduce cutting performance.
Arcimoto is recalling 2019 FUV motorcycles because the ignition switch lacks required 'Ignition' and 'Off' labels, which could lead to operator error.
BrucePac is recalling ready-to-eat chicken sausage products because they contain an undeclared pork casing. No adverse reactions have been reported.
Basic Reset Inc. is recalling Miracle Facelift Masque because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Zimmer Biomet is recalling 5.4 million temporary surgical devices because non-highly polished implants may adhere to the packaging bag.
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 5.4 million Universal Locking Plates because non-highly polished implants may adhere to the packaging bag.
Zimmer Biomet is recalling various knee systems because non-highly polished implants may adhere to the LDPE bag.