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.
Boston Scientific is recalling eight Model 3300 LATITUDE Programming Systems because a software defect may cause EGM trace channels to display as a flat line during specific tests.
Blue Ortho is recalling 3,471 GPS Tracker Instructions For Use documents because some low-temperature sterilization conditions were approved based on rational documents.
Becton Dickinson is recalling 45 Bard 3F SL PowerMidline kits in Italy, Spain, and the UK because they lack the stylet/T-lock assembly listed on the label.
Exactech is recalling 12 Equinoxe Platform Fracture Stems because they may be incorrectly laser marked as right stems when they are left stems.
Microbiologics Inc is recalling KWIK-STIK Klebsiella pneumoniae units because the product was confirmed to be NDM-1 negative instead of the required NDM-1 positive strain.
Capital Seaboard is recalling Gracie's Pointe frozen raw shrimp because it was inadvertently released for distribution while under an FDA import alert.
Nurture Inc. is recalling Happy Tot Superfoods Gluten Free Oat Bars due to mold growth. The product is intended for toddler consumption.
Microbiologics Inc is recalling KWIK-STIK 2 Pack units where the NDM-1 positive strain was confirmed to be negative.
Boehringer Ingelheim is recalling Catapres tablets because an extraneous peak was observed during dissolution testing. The affected lots were distributed nationwide and in Puerto Rico.
Thread Counsel Inc is recalling LOM Disposable Surgical Gowns due to missing labeling and potential non-compliance with FDA standards.
Nurture Inc. is recalling Happy Tot Superfoods Gluten Free Oat Bars because mold growth was observed. The affected bars are intended for toddler consumption.
Nurture Inc. is recalling Happy Kid Gluten Free Fruit & Oat Bars due to mold growth. Consumers should stop eating the product and return it to the store.
Boehringer Ingelheim is recalling specific lots of Catapres tablets because an extraneous peak was observed during dissolution testing.
Medline Industries is recalling 26 Quidel Triage BNP Calibrators because the product was compromised during shipment. The recall affects domestic distribution in CA, NY, TX, and VA.
Boston Scientific is recalling one unit of the Visual-ICE MRI Cryoablation System Mobile Connection Panel due to an incorrectly installed base.
Jarrow Formulas is recalling 533 units of N-A-C 500 mg capsules because they were mislabeled as a different product.
RTI Surgical is recalling 420 units of Streamline TL Navigation System taps because they have experienced binding with other devices.
Siemens Medical Solutions is recalling 22 Artis one systems because the examination room monitor may become intermittently dysfunctional, causing display issues.
Becton Dickinson is recalling Bard 3F SL PowerMidline Full Kits because they may lack the stylet/T-lock assembly, potentially causing procedural delays.
Microbiologics Inc is recalling KWIK-STIK Klebsiella pneumoniae units that were confirmed to be NDM-1 negative instead of the required NDM-1 positive strain.
Boehringer Ingelheim is recalling specific Catapres tablets because an extraneous peak was observed during dissolution testing. The recall covers products distributed nationwide and in Puerto Rico.
Exactech is recalling 25 Equinoxe Platform Fracture Stems because they may be incorrectly laser marked as right stems instead of left stems.
Smith & Nephew is recalling TWINFIX ULTRA HA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.
Smith & Nephew is recalling HEALICOIL RSB SA absorbable suture anchors because improper packaging seals may breach the sterile barrier.
Genesis Partnership Company SA is recalling Killz Germz Hand Sanitizer because testing showed ethanol levels as low as 62%, below the labeled 70% claim.