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.
Sweets & Desserts, Inc. is recalling 200 units of Tres Leches Chocolate in Puerto Rico due to undeclared food dyes.
Amerisource Health Services is recalling specific lots of Glipizide Extended-Release tablets because they failed to meet dissolution specifications.
LeMaitre Vascular is recalling 46 units of Reddick Scoop Tip Cholangiogram Stiffer Catheters because the latex warning symbol was missing from the packaging.
Siemens is recalling Axiom Artis fluoroscopic x-ray systems because a gap in the wireless foot switch housing could allow liquids to penetrate the interior, potentially causing the switch to fail.
Synergy Rx is recalling Hydroquinone 28% Solution because it may not be sterile. The recall covers all lots distributed nationwide.
Synergy Rx is recalling Tretinoin 0.02% in Oil Free Cream because of a lack of assurance of sterility and CGMP deviations.
Ortho-Clinical Diagnostics is recalling specific lots of VITROS Lithium Slides due to intermittent imprecision in test results.
Synergy Rx is recalling specific glycolic acid prescription products due to a lack of assurance of sterility and CGMP deviations.
LeMaitre Vascular is recalling Reddick Scoop Tip Cholangiogram Catheters because the latex symbol was not printed on the packaging.
Radiometer America Inc. is recalling ABL90 Flex analyzers because the 'cord blood' sample type was changed to 'cord blood arterial' and 'cord blood venous.'
LeMaitre Vascular is recalling Reddick Scoop Tip Cholangiogram Catheters because the latex warning symbol was missing from the packaging.
LeMaitre Vascular is recalling 340 Reddick Cholangiogram Stiffer Catheters because the latex symbol was not printed on the packaging.
REV Recreation Group is recalling 2017 Fleetwood Bounder and Holiday Rambler Vacationer RVs because Federal Placards list the wrong tire size.
MicroAire Surgical Instruments is recalling 362 K-Wires due to mislabeling that incorrectly identified them as dual trocar instead of single trocar.
Mako Surgical Corporation is recalling 777 MAKO RIO THA Application User Guides because five AFMEA Risk Control Measures are missing from the documents.
Merge Healthcare is recalling Unity PACS software version 11.0 because reports faxed to referring physicians were missing demographic header information.
Encore Medical is recalling 297 Turon Impaction Fixtures because polymer material wore off during assembly, potentially affecting the humeral stem coating.
Remel Inc is recalling Haemophilus Test Medium agar plates because poor organism growth may result in incorrect susceptibility test results.
Actavis Inc is recalling specific lots of Levofloxacin Ophthalmic Solution because the product failed impurity specifications for a related compound.
Teva Pharmaceuticals is recalling Risedronate Sodium Delayed-release Tablets because stability testing revealed low out-of-specification dissolution results.
Metrex Research is recalling CaviWipes Extra Large surface disinfectants because they may have been contaminated during the packaging process.
LEO Pharma is recalling 272,062 tubes of Calcipotriene Cream because the label omitted a required excipient and a warning about contact dermatitis.
Merge Healthcare is recalling Merge Cardio software versions 9.0 and 10.0 because measurements from images or US carts do not transfer to reports in the correct unit of measure.
Siemens is recalling nine Biograph Mobile PET/CT systems because mobile-specific instructions were not shipped to a limited population of devices.
Merge Healthcare is recalling specific versions of Merge PACS software because studies may fail to propagate or import via the telmed protocol.