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.
Herbal Doctor Remedies is recalling Lump Shrinker capsules because the products are misbranded as unapproved new drugs.
Herbal Doctor Remedies is recalling Max Slim 500mg capsules because the products are misbranded as unapproved new drugs.
Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Conformis is recalling two iTotal PS Knee Replacement System kits because tibial trays were labeled with incorrect serial numbers and delivered to the wrong customers.
Trilliant Surgical, LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for two cannulated screw systems to update dry time parameters.
The Binding Site Group is recalling C-Reactive Protein Kits because a reagent is not performing to specification, potentially affecting low-concentration samples.
Butterfly Network, Inc. is recalling 11,183 Butterfly iQ Ultrasound Systems because they were distributed without an approved 510(k).
Qiagen Sciences LLC is recalling AmniSure ROM Test kits because the packaging displays an incorrect rinse time of 30 seconds instead of the correct 1 minute.
NutraBlend Foods is recalling Russian Bear 10000 Weight Gainer Formula Cookies and Cream flavor due to undeclared soy protein isolate.
Haemonetics is recalling TEG Manager software versions 1.1.0 through 4.1.1 because a defect causes incorrect out-of-range alerts for coagulation test results.
Lupin Pharmaceuticals is recalling 25,944 bottles of Lisinopril 30 mg tablets because a 5 mg tablet was found mixed into a 30 mg bottle.
NutraBlend Foods is recalling Russian Bear 10000 Weight Gainer Formula Vanilla due to undeclared soy protein isolate. The product was distributed to one customer in Canada.
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for the Gridlock Plating System to update dry time parameters.
Butterfly Network, Inc. is recalling the Butterfly iQ Ultrasound System Auto Bladder Volume Tool because it was distributed without an approved 510(k).
Philips is recalling 2,214 MRI Patient Monitoring Systems because the instructions for oxygen sensor calibration are incorrect for specific software versions.
Biomet is recalling 21 units of Comprehensive Reverse Shoulder Glenosphere Mini Baseplates because some packages contained two baseplates and no taper adapters.
Trilliant Surgical, LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for the Twist Sublatar Implant System to update dry time parameters.
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for Tiger Screw Systems to update dry time parameters.
Trilliant Surgical is recalling 117 units of 8mm HTR Sterile Hammer Toe Reaming Kits because they may contain two identical reamers instead of one concave and one convex reamer.
Conformis, Inc. is recalling four iTotal CR Knee Replacement System kits because they were labeled with incorrect serial numbers and delivered to the wrong customers.
NutraBlend Foods is recalling Russian Bear 10000 Weight Gainer Formula Banana flavor due to undeclared soy protein isolate.
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for its Two-Step Hammertoe Implant System to update dry time parameters.
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for Tiger Cannulated Screw Systems to update dry time parameters.
Natus Neurology is recalling 40 Olympic Brainz Monitors because required functional tests were not performed before release, meaning the manufacturer cannot verify system functionality.
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for the 3S Hemi Toe Implant System to update dry time parameters.