Severity 1 of 5
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.
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 is recalling 1,648,273 dental implant devices because pouches may not have been sealed during packing.
Biomet 3i is recalling Locator Abutment dental implants because pouches may not have been sealed during packing.
Teleflex Medical is recalling 45 units of the Weck EFx Classic Fascial Closure System because incorrect expiration dates were printed on the labels.
Biomet 3i is recalling Conical EP Pick-Up Coping 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.
Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutment dental implants because pouches may not have been sealed during packing.
Ortho-Clinical Diagnostics is recalling VITROS TSH Reagent Packs because calibration curves frequently fall outside quality parameters, potentially delaying test results.
Biomet 3i is recalling certain Gingihue Post Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Locator Abutment dental implants because pouches may not have been sealed during packing.
Becton, Dickinson and Company is recalling 14,089 vials of BD Tritest CD3 FITC/CD4 PE/CD45 PerCP because the label incorrectly states the product contains gelatin.
C.R. Bard is recalling 64 Medivance ArcticGel Neonatal Pads because the included instructions were missing required languages for CE-marked products.
Teva North America is recalling Children's Qnasl nasal aerosol canisters due to failed spray content uniformity tests. The FDA classified this as a Class III recall.
C.R. Bard is recalling 530 SureStep urine collection systems due to a labeling problem. The recall is voluntary and nationwide.
Teleflex Medical is recalling Horizon 24 Large Titanium Clips because manufacturing and expiration dates are missing from the blister pack labels.
Branan Medical is recalling AmediCheck Instant Test Cups because they may erroneously contain 12-panel cups due to a packaging error.
Alere San Diego is recalling Henry Schein One Step + Mono Rapid Test Devices because the product labeling incorrectly identifies the positive control material as human plasma.
Alere San Diego, Inc. is recalling the Cardinal Health Mono Rapid Test because the product labeling incorrectly identifies the positive control material as human plasma.
Alere San Diego, Inc. is recalling Proadvantage Mono Rapid Test Cassettes because the product labeling incorrectly identifies the positive control material as human plasma.
Teva North America is recalling 2,506 vials of MitoXANTRONE Injection USP because high levels of Impurity D were detected.
Alere San Diego is recalling the Stanbio Rely Mono Rapid Test because the product labeling incorrectly identifies the positive control material as human plasma.
Alere San Diego is recalling Signify Mono tests because the product labeling incorrectly identifies the positive control material as human plasma.
Alere San Diego is recalling Clearview MONO tests because the product labeling incorrectly identifies the positive control material as human plasma.
Alere San Diego is recalling Acceava Mono II Rapid Test Strips because the product labeling incorrectly identifies the positive control material as human plasma.
Tosoh Bioscience is recalling 41 sets of Progesterone 3 Calibrators because the included Instructions for Use (IFU) listed the incorrect lot number.
Sun Pharmaceutical Industries is recalling 16,085 bottles of Bupropion Hydrochloride Extended Release Tablets because they failed dissolution specifications.