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.
JMH International is recalling Chef Myron's Eurasian Fusion Sauce because it contains wheat-derived fermented soy sauce despite a gluten-free claim.
Chromsystems Instruments & Chemicals GmbH is voluntarily recalling 363 vials of MassChrom Amino Acid Analysis Plasma Control Level II due to a Class II device defect.
Becton, Dickinson and Company is recalling 619 vials of BD Multi-Check CD4 Low Control due to unexpected cell populations that may cause inaccurate flow cytometry results.
JMH International is recalling Chef Myron's Yakitori Sauce because it contains wheat-derived ingredients despite a gluten-free claim.
Canon Medical System is recalling 60 Aquilion Prime SP CT scanners due to a software defect that may prevent automatic scans, requiring rescans and contrast reinjection.
JMH International is recalling Chef Myron's Ponzu Sauce because it contains wheat-derived ingredients despite a gluten-free claim.
JMH International is recalling Chef Myron's Tangy Teriyaki Sauce because it contains wheat-derived ingredients despite a gluten-free claim.
Randox Laboratories is recalling Randox Mg R1 kits due to reduced linearity performance, which may affect the accuracy of magnesium test results.
Shilpa Medicare Limited is voluntarily recalling 2,611 bottles of Imatinib Mesylate 100 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations.
Asiaticon, SA de CV is voluntarily recalling V-Klean Hand Sanitizer Gel Alcohol 70% due to a lack of Current Good Manufacturing Practices (CGMPs).
JMH International is recalling Chef Myron's Tsukeyaki Sauce because it contains wheat-derived ingredients despite a gluten-free claim.
The Harvard Drug Group is recalling 841 cartons of Aripiprazole Tablets, 15 mg, because the product failed to meet dissolution specifications.
Ascend Laboratories LLC is recalling 1,200 bottles of Tizanidine 4mg tablets distributed in Michigan due to failed dissolution specifications.
Homestead Creamery is recalling 1,344 bottles of 10% Real Juice Lemonade due to possible contamination with chlorine sanitizer.
US Pharmaceuticals is recalling CVS Health Hydrating Healing Ointment due to low weight fill tubes identified in one lot.
Chromsystems is recalling 880 vials of MassChrom Cortisol, Cortisone Saliva Control Level I because the control lots may not meet stability criteria, potentially causing increased patient results.
ICU Medical is recalling 1,100 units of smallbore IV administration sets due to incorrect filter assemblies. The products were distributed nationwide.
Chromsystems is recalling MassChrom Cortisol, Cortisone Saliva Control Level II kits because control lots may not meet stability criteria, potentially causing increased results for patient cortisone samples.
Bausch & Lomb is recalling 31 MX60ET toric intraocular lenses because they may be missing toric axis marks, which are necessary for proper surgical placement.
Ethicon is recalling 15 units of PROCEED Surgical Mesh because a hair was found inside the primary packaging of a sterile device.
Janus Trade Group is recalling B. Braun Introcan Safety IV Catheters distributed in the US without required FDA 510(k) clearance.
Becton Dickinson is recalling 2.8 million BD Ultra-Fine Pen Needles because US cartons are missing specific compatibility information.
Chromsystems is recalling 6PLUS1 Multilevel Saliva Calibrator Sets because they may not meet stability criteria, potentially causing increased cortisone results in patient samples.
JFC International is recalling Yagumo Amanatto Gift Boxes because the imported sugar-coated sweet beans contain mold or may develop mold before the best before date.
Covidien LLC is recalling 3,217 Capnostream 35 Portable Respiratory Monitors because they may display a false 'Temperature Exceeds Limits' message and shut down without an alarm.