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.
Prinova US LLC is recalling MRI Amintoten Strawberry Powder due to the detection of cyclamates, an artificial sweetener prohibited in the United States.
Sisel International LLC is recalling SiselRipt postWORKOUT dietary supplements because they contain Cyclamates, an unapproved artificial sweetener.
CryoLife, Inc. is recalling BioGlue Spreader Tips because incorrect labels were applied to the packaging, and some required components were missing from the boxes.
Major Pharmaceuticals is recalling specific lots of Enalapril Maleate Tablets, 2.5 mg, because the product failed impurity specifications for a degradation product.
Prinova US LLC is recalling Amino Life brand BCAA 2:1:1 Instant Sunflower due to the detection of cyclamates, an artificial sweetener prohibited in the United States.
Aidarex Pharmaceuticals is recalling specific lots of Enalapril Maleate 5mg due to out-of-specification results for a degradation product during commercial stability.
Philips Healthcare is recalling 459 UNIQ systems because the shutter position resets to open when a new procedure type is selected, potentially losing previous settings.
Prinova US LLC is recalling Amino Life brand L-Leucine Instant Sunflower because it contains cyclamates, an artificial sweetener prohibited in the United States.
Bio-Rad is recalling 153 PR4100 Microplate Readers because the power supply connector can fit incompatible components, risking irreparable damage to the system.
Philips Healthcare is recalling 459 Centron systems because shutter settings reset when procedure types change, potentially affecting imaging accuracy.
Terumo is recalling Tubing Pack Convenience Kits labeled with an incorrect expiration date of April 30, 2019.
GE Healthcare is recalling 58 Brivo XR385 digital radiographic systems because placing weight on the detector can cause image artifacts, leading to patient exam retakes.
Ethicon, Inc. is recalling 72 units of PDS II sutures because they do not meet tensile strength specifications.
Brewer Company is recalling seven Access Hi-Low Exam Tables because over-crimped wire harness connectors may affect the vertical side switches.
OMNIlife science Inc. is recalling 16 units of ApeX-LNK Acetabular Inserts due to improper labeling on internal packaging and patient labels.
Prinova US LLC is recalling Reginator NV (41825) because it contains cyclamates, an artificial sweetener prohibited in the United States.
Abbott is recalling 2,521 CardioMEMS Patient and Hospital Electronics Units because they may display a false Error 5 message due to a configuration defect.
Human Design Medical is recalling 45 Vivo 65 home ventilators because some devices have an unreleased version of the Firmware upgrade tool.
Canadian Hospital Specialties is recalling specific lots of pediatric feeding tubes because they may be packaged with the incorrect length as labeled.
The Hain Celestial Group is recalling alba BOTANICA sport mineral sunscreen because the wrong product formulation was placed in the packages.
Siemens Healthcare Diagnostics is recalling 1,446 units of Dimension Vista CTNI Sample Diluent because a defective cap septum may cause erroneously elevated test results.
Cardinal Health is recalling Presource PBDS kits because a defect in the Gatorade pouch seal caused the pouch to leak within the kit.
Sun Pharmaceutical Industries is recalling one lot of Metformin Hydrochloride Extended Release Tablets because a piece of rubber glove was detected in a tablet.
Valeris Medical is recalling 113 Apollo XT Suture Anchors because the labels incorrectly identified the material as titanium instead of PEEK.
Fx Solutions is recalling specific lots of Humelock Offset Heads due to a breach in the external blister packaging.