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.
Philips is recalling 11 Ingenuity TF PET/MR systems because the PET Reconstruction Server database may lock up between scans, though no field issues have been reported.
Customed, Inc. is recalling 32 laparoscopy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
HoneyCombs Industries is recalling 133 units of Formula KB droppers because the powdered golden seal ingredient contained coliform bacteria levels above the specified limit.
Limacorporate S.p.A is recalling 93 units of SMR Shoulder Trial Heads because dimensions are out of specification, making assembly difficult.
HoneyCombs Industries is recalling 161 bottles of Formula C&F droppers because the powdered golden seal ingredient contained coliform bacteria levels exceeding specifications.
Transonic Systems Inc is recalling 2 mm Flow Probes due to programming errors causing incorrect meter readings.
Customed, Inc. is recalling Minor Laceration Trays because the sterilization processes and package integrity were not adequately validated.
Customed, Inc. is recalling 24 units of Breast Packs due to inadequate validation of sterilization processes and package integrity.
Neuro Kinetics is recalling 45 I-Portal NOTC systems because the OVAR research test was sold with an incorrect investigational label.
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because a software anomaly may reset user-configured parameters to defaults during installation.
Beckman Coulter is recalling Access Thyroglobulin Assay reagent packs because some may exhibit greater than 10% imprecision at low concentrations.
Transonic Systems Inc is recalling 3 mm Flow Probes due to a software defect that causes flow meters to display incorrect status messages.
HoneyCombs Industries is recalling 262 bottles of Expello-C because the powdered golden seal ingredient contained coliform bacteria levels exceeding specifications.
Customed, Inc. is recalling 960 Universal Drainage Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Vintage Pharmaceuticals is recalling 8,705 bottles of Lisinopril 40 mg tablets because they failed dissolution specifications. The affected lots were distributed nationwide and in Puerto Rico.
Physician Engineered Products, Inc. is recalling 97 Bright Embrace Single Bili Lights because the upper limit for ambient temperature was printed incorrectly in the instructions.
Transonic Systems Inc is recalling 2 mm Flow Probes due to programming errors causing incorrect meter readings.
Transonic Systems Inc is recalling 6 mm Flow Probes due to programming errors causing incorrect meter readings.
Transonic Systems Inc is recalling 2 mm Flow Probes due to programming errors causing incorrect meter readings.
Transonic Systems Inc is recalling 4 mm Flow Probes due to software defects causing incorrect meter readings.
Transonic Systems Inc is recalling 3 mm Flow Probes due to software defects causing incorrect readings on flow meters.
HoneyCombs Industries is recalling 68 units of Formula L droppers due to coliform counts exceeding specifications.
Bayer is recalling 5 million bottles of Contour Next Control Solution because improper shaking may cause inaccurate blood glucose meter readings.
HoneyCombs Industries is recalling 432 bottles of Golden Seal Extract because the product contained higher levels of coliform bacteria than allowed by specifications.
Biomet, Inc. is recalling five units of the Vision RingLoc Shell 50 mm hip prosthesis because they were assembled without screw hole plugs.