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.
Baxter is recalling certain Novum IQ Syringe Pumps manufactured or repaired after July 4, 2023, due to a design issue that may falsely detect a syringe flange when none is loaded, causing the pump interface to become stuck or display a System Error 21502.
Turncare has recalled certain Guardian 2 System controllers because a software issue prevented "low" and "terminal" battery alerts from displaying on the screen in specific circumstances when the device was not running patient therapy.
Remel, Inc. is recalling one lot of Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth due to off-color that may affect performance of this in-vitro diagnostic device.
BD BBL CultureSwab EZ Collection and Transport System (REF 220144) is being recalled because swabs may break during use. The recall affects units distributed nationwide in Maryland.
Zydus Pharmaceuticals is recalling Icosapent Ethyl Capsules due to burnt or melted capsules caused by oxidation from leakage of capsule contents. The recall affects 11,616 bottles distributed in Illinois, Pennsylvania, and Mississippi.
Comvita Manuka Honey + Reishi is recalled due to a leaking induction seal on the packaging. The product may not be properly sealed.
Comvita Manuka Honey + Lion's Mane for Focus is recalled due to a leaking induction seal on the packaging. Approximately 2,730 units distributed across multiple U.S. states are affected.
Civco Medical Instruments is recalling BX2 Needle Guide, Part Number 644-094, because tight tolerance during attachment to the transducer can cause a pinhole breach in the transducer cover.
Foundation Medicine is recalling the FoundationOne Companion Diagnostic (F1CDx) due to an incorrect negative claim displayed on the claims page, though device variant information was correctly shown in the tumor profiling section of the approved test report.
Pepsi Beverages Company is recalling Dr. Pepper Zero Sugar aluminum cans because the product contains full sugar despite being labeled as zero sugar. Affected 12 and 24 pack cases were distributed to Florida, Georgia, and South Carolina.
Foundation Medicine is recalling two FoundationOne Companion Diagnostic (F1CDx) test reports that contained an incorrect negative claim on the claims page, though the device variant information displayed correctly in the tumor profiling section.
Treehouse Foods is recalling Sysco Classic and Bay Valley Foods Thank You chocolate pudding in 7lb cans due to post-process container damage that could allow microbial growth and cause containers to swell or explode.
Spectrum Advanced Gel Hand Sanitizer (70% ethyl alcohol, 8 FL OZ) has been recalled nationwide because affected batches contain cloudy appearance and test below the claimed 70% alcohol concentration, making them less effective.
Apotex Corp. is recalling Lacosamide Oral Solution because certain bottles may leak when stored horizontally. Patients taking this seizure medication should contact their pharmacy or healthcare provider.
Beckman Coulter is recalling DxI 9000 Access Immunoassay Analyzers running software version 1.20 because the update introduces error codes that prevent assays from being performed and may delay result generation.
Flux Technology Inc. is recalling the Lazervida 10W diode laser cutter and engraver because it does not fully meet current Federal performance standards for laser device safety features and labeling.
Amerisource Health Services LLC is recalling Indomethacin Extended-Release Capsules 75 mg due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 21 cartons distributed nationwide.
Healthmark Industries is recalling Pre-filled Water Syringes (Model SW-010-100 and SW-010) after duodenoscope contamination was linked to improper use of the syringes outside their intended purpose.
Virtual Incision Corporation is recalling MIRA Surgical System units with Software Version 4.0.3 due to potential interrupted motion on the surgeon control console display caused by software latency.
Beckman Coulter Mishima is recalling sample probes due to a manufacturing defect where rounded and chamfered corners prevent proper air layer formation, causing sample dilution and inaccurate test results.
Lutron-branded power interfaces for LED tape lights can fail during power surges like lightning strikes, creating a shock hazard. About 1,944 units are affected; no injuries have been reported.
Abbott Diagnostics Alinity I Free PSA reagent units may have been stored outside recommended conditions due to transit delays from severe thunderstorms, potentially affecting test accuracy or timing.
HemoCue Inc HemoTrol High Level 3 control product (Catalog No. 171003002) is being recalled because transit delays and severe thunderstorms may have caused it to be stored outside recommended temperature ranges, potentially resulting in incorrect or delayed test results.
BD Microbiology MacConkey II Agar media may have been stored outside recommended temperature conditions due to transit delays from severe thunderstorms, potentially resulting in incorrect or delayed test results.
Abbott Diagnostics Alinity I Anti-CCPS Reagent is being recalled due to transit delays from severe thunderstorms that may have exposed the product to storage conditions outside the manufacturer's recommendations, potentially causing incorrect or delayed test results.