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.
Biomet 3i, LLC is recalling 1,648,273 Provide Abutment Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Gold-Tite Square Uniscrew dental implants because pouches may not have been sealed during packing. The recall affects 1,648,273 units distributed worldwide.
Biomet 3i, LLC is recalling Conical 25 degree Angled Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling EP Twist Lock Coping Dental implants because pouches may not have been sealed during packing.
Zydus Pharmaceuticals is recalling 223,776 bottles of Venlafaxine Hydrochloride ER capsules because retained samples failed dissolution specifications.
Medtronic is recalling Valleylab Laparoscopic Straight Spatula Electrodes due to a potential sterile barrier breach. The recall affects 13,516 units distributed worldwide.
Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
Biomet 3i is recalling 1,648,273 EP Healing Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Quickbridge TM Cap Dental implants because pouches may not have been sealed during packing.
LeMaitre Vascular is recalling 380 units of the 1.5 mm HYDRO LeMaitre Valvulotome because the wire may detach, rendering the device inoperable.
Medtronic is recalling 210 units of Valleylab Laparoscopic Argon Sharp Needle Electrodes due to a potential sterile barrier breach.
Avid Medical is recalling 240 MOHS procedure trays because they contained a latex dressing that was not labeled as such.
Biomet 3i is recalling Gingihue 15-degree angled post dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Locator Extra Light Retention Males dental implant pouches because they may not have been sealed during packing.
Biomet 3i is recalling Preformance Post Dental implants because pouches may not have been sealed during packing. The recall covers 1,648,273 devices distributed worldwide.
Biomet 3i, LLC is recalling Hex Try-in Screws because pouches may not have been sealed during packing, potentially compromising sterility.
Danville Materials is recalling Perioscopy Sheaths because validation data to support the 3-year shelf-life claim on the label is unavailable.
Straumann Manufacturing is recalling 70 Bone Level Implants because misalignment with the Loxim transfer piece may result in incorrect implant positioning.
Zydus Pharmaceuticals USA Inc. is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Capsules because retained samples failed dissolution specifications.
Biomet 3i, LLC is recalling 1,648,273 Provide Impression Coping dental implant devices because pouches may not have been sealed during packing.
Biomet 3i is recalling 1.6 million Temporary Non-Hexed Cylinder Dental Implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 IOL Abutment Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling specific dental implants because their pouches may not have been sealed during packing.
Resmed is recalling 42 Quattro Air FFM masks labeled as Medium vented but containing Large non-vented masks.
Biomet 3i is recalling specific Gingihue dental implants because pouches may not have been sealed during packing.