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.
Gentherm Medical is recalling 182 Blanketrol II Model 222S thermal regulating systems because overheating of the 115V CPU board may cause the device to shut down.
Spectral Instruments Inc is recalling 35 Ami HTX units because the 'X-Ray On' banner may briefly disappear during the run readiness check.
Golden State Medical Supply is recalling 1,200 bottles of Carbamazepine 200mg tablets due to tablets containing black specks.
Prospector Popcorn is recalling Chocolate Mocha Gourmet Popcorn because the label understated carbohydrate and cholesterol levels.
Paragon 28, Inc. is recalling a custom-made foot implant due to elevated oxygen levels that may reduce material ductility.
Kico Knee Innovation is recalling 78 ARVIS Surgical Navigation System Gen 2 units because an internal sensor issue may cause the eyepiece image to appear tilted.
Prospector Popcorn is recalling Fudge Brownie Gourmet Popcorn because the packaging incorrectly lists higher amounts of potassium and calcium than the product actually contains.
FDA is recalling 327 EndoFLIP Systems because a software error incorrectly flags catheters as expired, making them unavailable for clinical procedures.
Novartis is recalling specific lots of Diovan (valsartan) 160 mg tablets because they failed to meet required dissolution specifications.
Shoolin Pharma Chem LLP is recalling Tadalafil USP 0.100 KG bags due to Current Good Manufacturing Practice (CGMP) deviations noted during an FDA inspection.
Ventana Medical Systems is recalling navify Digital Pathology software versions 2.5 due to reported discrepancies between images and metadata in the viewer.
Spacelabs Healthcare is recalling 6,074 Xhibit Central Station units because an off-the-shelf DisplayPort audio/video splitter component may fail.
Heritage Pharmaceuticals is recalling Clindamycin Palmitate Hydrochloride oral solution due to the presence of particles and white flakes in reconstituted bottles.
Terumo Medical Corporation is recalling 7,490 units of Glidesheath Slender A-Kits because they were packaged with a 0.025 guidewire instead of the specified 0.021 guidewire.
Shoolin Pharma Chem LLP is recalling Sildenafil Citrate USP due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection.
W L Gore & Associates is recalling 13 GORE VIABIL Short Wire Biliary Endoprostheses because they were incorrectly labeled with the wrong model number and dimensions.
Straumann USA LLC is recalling 417 GM Helix dental implants because the implant inside the packaging may not match the outer carton label, potentially causing installation issues.
Remel Europe Ltd. is recalling specific lots of Neisseria meningitidis Gp C in vitro diagnostics that fail to meet performance criteria.
Galt Medical Corporation is recalling 114,260 Boston Scientific Enhance Transcarotid/Peripheral Access Kits because black depth markings may detach from the outer sheath.
W L Gore & Associates is recalling 13 GORE VIABIL Short Wire Biliary Endoprostheses because they were incorrectly labeled with the wrong model number and dimensions.
The FDA is recalling procedure kits containing MEDICOM Ritmed Neurological Sponges because of unexpected variability in endotoxin levels. This affects consumers who have received or plan to receive these kits.
Straumann USA LLC is recalling 175 units of BLT dental implants that may be 12mm instead of the labeled 14mm length.
Shoolin Pharma Chem LLP is recalling Sildenafil Citrate USP 1.00KG bags due to CGMP deviations noted during an FDA inspection.
Freudenberg Medical recalls 40 Blom-Singer Classic Indwelling Voice Prostheses due to labeling errors that could cause confusion about product contents.
Boston Scientific Corporation is recalling specific Radial Jaw 4 Standard Capacity Biopsy Forceps because there is a potential for a breach in the sterile barrier of the device packaging.