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.
The Anspach Effort, Inc. is recalling 63 G1 Dissection Tools because several product codes were inadvertently left off of Hold 1503.
Abbott Medical Optics is recalling 84 SENSAR Foldable Intraocular Lenses because they were not checked prior to release, which may result in the release of mislabeled units.
Carefusion 2200 Inc is recalling Broselow Pediatric Emergency System pouches because the PINK/RED Oxygen Delivery Module contains an 8 cm airway instead of the labeled 5 cm size.
Invivo Corporation is recalling 639 Philips Expression Information Portal (IP5) units because display numerics may freeze and menu keys may disable after extended run time.
McKesson Medical Imaging Group is recalling McKesson Radiology software versions 12.1.1 and 12.2 because the STAT priority icon was not displayed in the Study List when a study was opened.
Lupin Pharmaceuticals is recalling 5,880 bottles of 40 mg Lisinopril tablets because they were manufactured using active pharmaceutical ingredients that failed specifications.
Abbott Medical Optics is recalling 131 TECNIS OptiBlue intraocular lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Abbott Medical Optics is recalling 10 TECNIS Symfony intraocular lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Sun Pharmaceutical Industries is recalling specific lots of Carvediol Tablets because they failed impurity and degradation specifications.
Abbott Medical Optics is recalling SENSAR 1-Piece Intraocular Lenses because they were not checked prior to release, which may result in the release of mislabeled units.
Old World Spices & Seasonings Inc is recalling EAT Barbeque Zero to Hero Sweet Rub because some bottles lack a statement noting the product contains MSG.
Integra LifeSciences is recalling 320 packages of Spinal Tray 24G Gertie Marx kits because one lot was shipped without the required needle introducer.
Siemens Medical Solutions is recalling 338 Syngo.x PACS systems because a software error caused volume calculations for prostate and liver to be too high.
Abbott Medical Optics is recalling 70 units of TECNIS OptiBlue Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.
POPSALOT, LLC is recalling Popsalot Moroccan Mystique 3.5 oz because gluten levels were found above the regulatory threshold.
Sun Pharmaceutical Industries is recalling Carvediol Tablets, USP, 25 mg, because the product failed impurities and degradation specifications.
Abbott Medical Optics is recalling 77 TECNIS Multifocal Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Hologic is recalling 570 units of the Sertera Biopsy Device due to incorrect labeling on the sterile kit.
Shearer's Snacks is recalling Keebler Sugar Wafers, Vanilla, because the refined granulated sugar ingredient contains extraneous foreign matter.
Siemens Medical Solutions is recalling 338 Syngo.via systems because a software error caused volume calculations for prostate and liver to be too high.
Siemens Healthcare Diagnostics is recalling IGF-I reagents because the required incubation time for pretreatment solution equilibration is 24 minutes, not as previously indicated.
Abbott Medical Optics is recalling 217 TECNIS 1-Piece Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Pentax of America Inc. is recalling 1,719 video bronchoscopes because they contain an incorrect Operation and Reprocessing IFUS.
Sun Pharmaceutical Industries is recalling specific lots of Carvediol Tablets, USP, 6.25 mg, because they failed impurities and degradation specifications.
Zatarains Scampi Pasta Dinner is being recalled because it was made with flour from a General Mills recall.