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.
Roche Diagnostics is recalling two cobas c513 Analyzers due to a quality issue with high pressure solenoid valves.
Vitony Bakery is recalling 2,354 units of Cheese-Guava Pudding Cake because the product fails to declare FD&C Yellow #5 and FD&C Yellow #6.
LeMaitre Vascular is recalling 62 units of Aortic Occlusion Catheters because the packaging lists the incorrect device size.
Helena Laboratories is recalling 65 kits of Titan Gel Serum Protein Control due to customer complaints about a narrow assay range.
Boston Scientific is recalling AMS 800 Artificial Urinary Sphincter belt cuffs labeled as 4.5 cm but measuring 4.0 cm due to mislabeling.
Fujifilm is recalling 174 FDR Go Plus mobile X-ray systems because a graphics driver issue may cause the device to display a Blue Screen of Death.
Karl Storz Endoscopy is recalling 14 Flexible Intubation Fiberscopes because they were improperly manufactured with a double port luer instead of a single port luer.
Stryker GmbH is recalling 28 Endotrac ECTR Hook Blade kits because the sterile bag seal integrity may be compromised.
Roche Diagnostics is recalling specific lots of the Elecsys Anti-CCP Immunoassay due to performance issues when used with plasma samples on certain analyzers.
Stryker GmbH is recalling 1,533 Endotrac EPF/EGR Triangle Blades because the sterile bag seal integrity may be compromised, potentially affecting sterility.
DRG Instruments GmbH is recalling 8 kits of Salivary Progesterone HS ELISA due to significantly lower results in low measuring ranges.
Stryker GmbH is recalling 1,959 Endotrac ECTR Hook Blades because the sterile bag seal may be compromised, potentially affecting sterility.
Ad-Tech Medical Instrument Corporation is recalling 18 Spencer Probe Depth Electrodes because two units labeled as 8-contact were actually 6-contact. No patient impact was reported.
Stryker GmbH is recalling 35 Endotrig ETF Hook Blades because the sterile bag seal integrity may be compromised, potentially affecting sterility.
Phadia Ab is recalling 387 Phadia 1000 immunodiagnostic instruments due to a liquid sensor error. The recall affects facilities in 27 US states.
Bausch & Lomb is recalling specific Laseredge Knives used in ophthalmic surgery because they may have dull edges.
Stryker GmbH is recalling 251 Endotrac EPF/EGR Push Blades because the sterile bag seal integrity may be compromised.
Stryker GmbH is recalling 2,248 Endotrac EPF/EGR Hook Blades because the sterile bag seal may be compromised, potentially affecting sterility.
PepsiCo is recalling 1,000 units of Diet Mountain Dew promotional bottles in Michigan because the label states 'Diet' but the product is actually full-calorie Mountain Dew.
Karl Storz Endoscopy is recalling 22 flexible neuro-fiberscopes because they were manufactured with the incorrect channel port.
Medline Industries is recalling 11,962 sterile piston irrigation syringe trays because samples showed incomplete or open packaging seals.
Stryker GmbH is recalling 53 Endotrac ECTR Triangle Blades because the sterile bag seal may be compromised, potentially affecting sterility.
Agilent Technologies is recalling MassHunter Quantitative Analysis Software versions B.07 or below due to a defect that causes sample name mismatches and prevents saving changes.
Baxter Healthcare is recalling Exactamed 5 mL Oral Dispensers because pharmacy packs may contain 10 mL dispensers.
Ad-Tech Medical Instrument Corporation is recalling Skull Anchor Bolts because supplemental information incorrectly indicated they were approved for use in the MR environment.