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.
Guerbet LLC is recalling 3,860 Optiray syringes because an RFID formatting error causes the injector to read the product as expired, preventing injection.
Sonora Mills Foods is recalling specific batches of PopChips Sour Cream & Onion Potato Popped Chips because they may contain gluten levels exceeding the firm's specification.
Helena Laboratories is recalling 24 SPIFE ImmunoFix-6 kits because the plates lack control wells in the patient 1 area.
GE Healthcare is recalling 599 Achilles Insight Bone Sonometers because they were shipped with European power cords that do not meet local safety requirements for protective earth connection.
Mylan Laboratories is recalling 19,165 vials of Rifampin for Injection due to elevated unknown impurities that may reduce product effectiveness.
Unipharma, LLC is recalling DrKids Children's Natural Cough Syrup due to a precautionary measure regarding potential contamination with B. cepacia bacteria.
Ethicon, Inc. is recalling 852 units of STRATAFIX Spiral PDS Plus Violet 27 sutures because they do not meet internal strength testing specifications.
Repro-Med Systems is recalling 1,990 pouches of 26-gauge subcutaneous safety needle sets due to mislabeled needle lengths.
Stryker Neurovascular is recalling 190 8F Balloon Guide Catheters because they were incorrectly packaged in 9F Balloon Guide Catheter packaging. The affected lot was distributed only outside the United States.
Becton Dickinson is recalling specific lots of BD Microtainer SST- Amber tubes because damaged reservoirs may cause insufficient sample volumes and erroneous test results.
Becton Dickinson is recalling BD Microtainer PST Tubes with Lithium Heparin because damaged reservoirs may cause insufficient sample volume and erroneous test results.
Ethicon, Inc. is recalling 416 units of STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle sutures because the product does not meet internal strength testing specifications.
Fetting's Frozen Foods LLC is recalling specific lots of Fetting's Family Breads White Bread in Minnesota due to the potential presence of a foreign object.
PopChips Variety Pack is being recalled because some batches may contain gluten levels exceeding the firm's specification.
Abbott Laboratories is recalling 2,922 cans of Calcilo XD infant formula due to off color, odor, and compromised can seams that may allow air entry.
Sonora Mills Foods is recalling PopChips Sea Salt & Vinegar Potato Popped Chips because some batches may contain gluten levels exceeding the firm's specification.
Becton Dickinson is recalling specific lots of BD Microtainer Tubes with FE Glycolytic Inhibitor because damaged reservoirs may cause insufficient sample volumes and erroneous test results.
Wismettac Asian Foods is recalling Nori Ajitsuke because the label incorrectly lists seafood species. The product contains skipjack tuna and krill.
Conformis, Inc. is recalling two iTotal Hip Replacement femoral stems (sizes 13 and 15) because they were packed in each other's packaging.
GE Healthcare is recalling 241 Achilles Express Bone Sonometers because they were shipped with power cords that do not meet local safety requirements for protective earth connection.
Roche Diagnostics is recalling Tina-quant Soluble Transferrin Receptor (sTfR) assays due to updated claims regarding rheumatoid factor interference.
K2M, Inc. is recalling 503 Special Connector Instruments because they were developed without adequate consideration for a new regulatory filing.
Baxter Healthcare is recalling Exactamed 5 mL Oral Dispensers because pharmacy packs may contain 3 mL dispensers, risking inaccurate dosing.
K2M, Inc. is recalling Yukon Polyaxial Screws because a manufacturing error may prevent them from mating with the screw inserter or set screw as intended.
Leica Biosystems is recalling three Aperio CS2 CE IVD scanners due to incorrect sensors that may affect image quality and analysis results.