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.
Confidence Inc. is recalling Prenatal Multi-V + DHA tablets because they contain undeclared ingredients, including HPMC and several food dyes.
Siemens Medical Solutions USA is recalling 605 ARTIS Pheno interventional fluoroscopic X-ray systems due to a potential hardware issue that may cause thermal effects and damage to system parts.
Arrow International Inc. is recalling 7,024 units of Hands-Off Multi-Lumen Central Venous Catheters because packaging may not be sealed, potentially compromising sterility.
Terumo is recalling 128 CDI Blood Parameter Monitoring System 500 H/SAT units because a hybrid intensity shift causes the automated Color Chip Test to fail, disabling the H/Sat module.
Zimmer Biomet is recalling 12 Echo Bi-Metric Hip Stems because they may have been mixed with a different model. The error could extend surgery time.
Apollo Endosurgery Inc. is recalling 54 units of the Apollo Lap-Band AP System Small with RapidPort EZ because a component was missing from the package.
Nico Corp. is recalling 204 sterile Shepherd's Hook accessories because they were shipped with incorrect transport labels instead of product labels.
Dr. Reddy's is recalling 40 mg Atorvastatin Calcium tablets because stability testing showed impurity levels exceeding specifications.
Terumo is recalling 128 CDI System 500 monitors because a subset of devices fail the automated H/Sat Color Chip Test. This failure disables the H/Sat module but does not cause device inaccuracy.
Super Store Industries is recalling Sunny Side Farms Peanut Butter Cup Ice Cream because some containers are filled with Butter Pecan ice cream.
Confidence Inc. is recalling Nitro-Cross 60s supplements due to undeclared ingredients including HPMC and Titanium Dioxide.
KZRV is recalling 2017-2019 Durango, Venom, and Sidewinder trailers because the Federal Certification label lists the wrong tire size, which could lead to incorrect tire installation.
ICU Medical is recalling 160,016 blood sets because some were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
ICU Medical is recalling 160,016 Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Baxter Healthcare is recalling 191,256 bags of Levofloxacin Injection in 5% Dextrose due to high out-of-specification potency results.
ICU Medical is recalling 160,016 blood administration sets labeled as DEHP-free, though they may contain small amounts of DEHP.
PharMEDium Services, LLC is recalling 575 syringes of 10 mg/mL Rocuronium Bromide because the product was released while a hood certification discrepancy was under investigation.
Seroyal International is recalling Genestra AFA-gen capsules because microcystin levels exceeded the specified limit of 1 ppm.
ICU Medical is recalling 85-inch Y-Type Blood Sets because some units are labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
ICU Medical is recalling 160,016 Y-Type Blood Sets because some were labeled as not containing DEHP, though they may contain small amounts.
ICU Medical is recalling 160,016 blood sets labeled as DEHP-free because they may contain small amounts of DEHP.
ICU Medical is recalling Lopez Valve, Sterile blood tubing accessories because some units were incorrectly labeled as not containing DEHP, though they may contain small amounts.
ICU Medical is recalling specific blood tubing sets because they were labeled as not containing DEHP, even though they may contain small amounts of the chemical.
ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP.
ICU Medical is recalling 160,016 blood sets because some were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.