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.
Siemens is recalling 177 ACUSON SC2000 ultrasound systems due to a software issue in the Stress Echo feature that may require studies to be repeated.
AGFA Corp. is recalling IMPAX CV Pediatric Echo Reporting software in South Carolina due to a known software defect in the OCR service.
Wockhardt USA LLC is recalling 8,712 bottles of Metoprolol Succinate Extended-Release Tablets, 100 mg, because they failed dissolution testing.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur TSH3 Ultra Ready Packs because samples containing fluorescein may interfere with assay results.
Siemens is recalling 257 ACUSON SC2000 ultrasound systems due to software issues that may cause incorrect color flow data display and Doppler waveform failures.
Stonyfield Farm is recalling specific lots of YoBaby Pear/Peach Organic Whole Milk Yogurt due to elevated levels of coliforms.
SigmaPharm is recalling four lots of Liothyronine Sodium Tablets 5 mcg due to potential cross-contamination with trace amounts of a previously manufactured product.
Teva Pharmaceuticals is recalling 53,452 bottles of 8 mg Buprenorphine Hydrochloride sublingual tablets because stability testing revealed high out-of-specification impurity levels.
SCM True Air Technologies is recalling 24 JK Bariatric Beds nationwide due to lack of design controls, missing Device Master Records, and unapproved vendors.
Pepsi Beverages Company is recalling specific Lipton Pure Leaf Iced Tea products due to consumer complaints about apparent mold.
Stonyfield Farm is recalling YoToddler Raspberry/Pear Cereal Organic Whole Milk Yogurt due to elevated levels of coliforms.
Fujifilm Medical System USA is recalling 14 MXR-35 Diagnostic X-ray High Voltage Generators because the labeling did not include the certification statement required by 21 CFR Part 10 10.2.
Ortho-Clinical Diagnostics is recalling VITROS TT4 Calibrators due to potential calibration failures or low quality control results.
Pepsi Beverages Company is recalling specific Lipton Pure Leaf Iced Tea products due to consumer complaints about apparent mold in the beverage.
Pepsi Beverages Company is recalling specific lots of Lipton Pure Leaf Iced Tea Unsweetened due to consumer complaints of apparent mold.
Hospira Inc. is recalling specific cystoscopy and irrigation sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.
Pepsi Beverages Company is recalling Lipton Pure Leaf Iced NTS Peach Tea 12 Packs produced in early March 2014 due to consumer complaints of apparent mold.
Stonyfield Farm is recalling 427 cases of YoBaby Vanilla Organic Whole Milk Yogurt due to elevated levels of coliforms.
Arrow International Inc. is recalling Arrowgard Blue and Blue Plus catheters because the packaging incorrectly lists an echogenic needle, which may not be present.
H:20 Innovations is recalling Meijer Baby Pediatric Electrolyte drinks due to a seal defect identified during a complaint investigation.
Forest Pharmaceuticals is voluntarily recalling one lot of Bystolic (nebivolol hydrochloride) tablets because dissolution test results failed to meet specifications.
Pepsi Beverages Company is recalling specific 12-packs of Lipton Pure Leaf Iced Tea Lemon due to consumer complaints about apparent mold in the product.
SCM True Air Technologies is recalling 83 MaXair True Low Air Loss Mattress Replacement Systems due to design control and documentation deficiencies.
Pepsi Beverages Company is recalling specific Lipton Pure Leaf Iced Tea Lemon 6-packs produced in early March 2014 due to consumer reports of apparent mold.
Hospira is recalling specific latex-free extension sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.