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.
Zimmer Biomet is recalling Lateral Troch Plate Full Crimp units because the internal patient label may be incorrect, though the product itself is correct.
Randox Laboratories is recalling 90 kits of HbA1c reagent (Batch 414553) due to low calibration absorbance that may affect performance.
SSM St. Clare Health Center is recalling specific lots of compounded succinylcholine chloride syringes because microbial growth was detected during a routine manufacturing simulation.
SSM St. Clare Health Center is recalling specific lots of compounded Hydromorphone PCA cartridges due to a lack of sterility assurance. No distributed product has been confirmed to contain microorganisms.
SSM St. Clare Health Center is recalling a specific lot of compounded Amiodarone injectable bags due to a lack of sterility assurance. No distributed product has been confirmed to contain microorganisms.
SSM St. Clare Health Center is recalling Fentanyl 10 mcg vials because microbial growth was detected during a routine manufacturing simulation. No distributed product has been identified as containing microorganisms.
SSM St. Clare Health Center is recalling specific lots of compounded Morphine PCA cartridges due to a lack of sterility assurance detected during routine testing.
Remel Inc is recalling Shigella sonnei Agglutinating Serum because it may fail to agglutinate within the specified minimum reaction time.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides because they may produce biased results when used with citrate plasma specimens.
Bayer HealthCare Pharmaceuticals is recalling 104,128 bottles of Chewable Low Dose Aspirin 81 mg due to failed stability specifications.
C.R. Bard is recalling I-125 QuickLink Cartridges because the quantity of seeds sent in shipments was incorrect.
Implant Direct is recalling 560 Spectra System/Legacy Guided Surgery Handle Kits because some guide inserts do not meet specifications, preventing proper drill passage.
Stryker Neurovascular is recalling 2 units of Stroke Fast Packs and Trevo Procedure Packs because the carton sleeve labels did not match the physical contents inside.
Stryker Neurovascular is recalling specific Stroke Fast Packs and Trevo Procedure Packs because the carton sleeve labels did not match the physical contents inside the packs.
Advanced Pharma Inc. is recalling NitroGlycerin 1 mg/10 mL syringes because stability data does not support the expiry dates. The recall affects 4,800 syringes distributed nationwide to hospitals.
Zimmer Biomet is recalling the ExploR Radial Head Replacement System because a complaint alleged the modular lock screw was missing from the package.
Invivo Corporation is recalling 4,535 Xper Flex Cardio Physiomonitoring systems because of intermittent communication between the host system and the device.
Philips is recalling 157 medical imaging systems because a software option prevents correct export of measurement data to external destinations.
Claris Lifesciences Inc. is recalling Ciprofloxacin in Dextrose Injection because the product is superpotent. The recall is voluntary and nationwide.
Philips is recalling 20 HeartStart MRx defibrillators because EtCO2 module contamination may prevent the device from displaying the CO2 waveform.
Osmotica Pharmaceutical Corp is voluntarily recalling 9,919 bottles of subpotent Methylphenidate Hydrochloride Extended-Release Tablets distributed nationwide.
B. Braun Medical Inc. is recalling 2,576 containers of 0.25% Acetic Acid Irrigation USP due to the presence of polyethylene particulate matter.
Gonzalez Wholesale Distributor is recalling Primera Negra Artificial Vanilla Flavoring because the product contains Coumarin.
John Zidian Co is recalling Gia Russa Spaghetti Dinner Sauce due to mold contamination and popped lids. The product was distributed in New York, Ohio, and Pennsylvania.
Teva Pharmaceuticals is recalling Amethyst oral contraceptive tablets because the packaging incorrectly states that Week 4 tablets are inactive, when all tablets are active.