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.
Sage Products Inc. is recalling Toothette Oral Care Antiseptic Oral Rinse because it was manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling the Toothette Oral Care Suction Swab System because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
OrthoPediatrics Corp is recalling 24 units of 7.0mm x 40mm pedicle screws because they were color anodized with the same color used for 5mm screws.
Sage Products Inc. is recalling Toothette Oral Care Suction Swabs because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Medtronic is recalling two units of the ANGLED DRILL (REF 6630902) because the drill tip extension is longer than the printed specification indicates.
Sage Products Inc is recalling Q.CARE Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling the Toothette Oral Care Short Term Oral Swab System because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Hetero Labs Limited is recalling 8,436 bottles of Famciclovir 500 mg tablets because high temperatures during distribution caused the tablets to become wet, stuck together, and disintegrated.
Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling QCare Rx Oral Cleansing and Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
General Mills is recalling Larabar Chocolate Chip Cookie Dough bars because they may contain individually wrapped Coconut Cream Pie Bars.
Synthes USA is recalling 5 units of Norian Drillable Inject because kit expiration dates do not align with the earliest component expiration dates.
Aesculap Implant Systems LLC is recalling ELAN 4 drill accessories because they were marketed without required FDA premarket notification clearance.
Sage Products Inc. is recalling Toothette Oral Care Suction Swabs because they were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling the Toothette Short Term Oral Swab System because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Cook Inc. is recalling 75 central venous catheter sets because they may not fit over a guide wire, potentially causing procedure delays.
B. Braun Medical is recalling Spinal & Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter above release specifications.
American Health Packaging is recalling 270 cartons of Aripiprazole Tablets, USP, 10 mg, because the active pharmaceutical ingredient did not meet all intended specifications.
Sage Products Inc. is recalling Toothette Oral Care Perox-A-Mint solution because it was manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Zimmer Surgical Inc is recalling 8,231 A.T.S. 4000TS Tourniquet Systems to update on-device labels and operator manuals, and to reduce the required separation distance from RF communication equipment.
Sage Products is recalling Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution due to potential cross-contamination with non-pharmaceutical products.
Sage Products Inc. is recalling Toothette Oral Care Daily Oral Cleansing Kits because they were manufactured on equipment shared with non-pharmaceutical products.
Cook Inc. is recalling specific lots of Central Venous Tray Triple Lumen Polyurethane Catheters because they may not fit over a guide wire, potentially causing procedure delays.
Siemens is recalling Artis one fluoroscopic X-ray systems because the monitor display may blink or show a blue/black screen.