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.
K C Pharmaceuticals is recalling Sunmark Eye Drops because the active ingredient was stored in a non-GMP compliant warehouse in Italy.
Siemens Healthcare Diagnostics is recalling Dimension Vista 500 and 1500 systems due to reagent probe performance decline that may affect patient and QC results.
Baxter Corporation is recalling two lots of sterile syringe tip caps because they were distributed before the completion of a required validation process.
Unistrip Technologies LLC is recalling 7,175 units of UniStrip1 Blood Glucose Test Strips because the company failed to submit a 510(k) for device labeling changes.
Zimmer Manufacturing B.V. is recalling 68 units of Trilogy Fiber Metal Acetabular Shells because the polar-hole threads were found to be undersized, preventing proper attachment to surgical instruments.
Advanced Sterilization Products is recalling STERRAD 100S cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.
Advanced Sterilization Products is recalling STERRAD 50 cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.
Getinge Disinfection AB is recalling 46-Series Medical Washer-Disinfector models 46-4 and 46-5 due to sediment residuals in the manifold caused by air pockets.
Willy's Inc is recalling 1,944 containers of Just Peachy Salsa because the label failed to list FD & C Yellow #5, a food color additive.
Intuitive Surgical is recalling Fluorescence Imaging Procedure Kits because storage conditions for indocyanine green are missing from the packaging.
Sessions Co. Inc. is recalling 2,200 lbs of shelled peanuts found to contain 26 ppb of aflatoxin. The product was distributed in Alabama.
The Coca-Cola Company is recalling 600 bottles of Coca-Cola Zero due to an equipment malfunction that caused ingredients to be blended at levels inconsistent with approved formulations.
Intuitive Surgical is recalling Fluorescence Imaging Procedure Kits because storage conditions for indocyanine green are missing from the packaging.
GE Healthcare is recalling Centricity Enterprise Archive software versions 4.0.x due to a potential data loss issue associated with HL-7 updates.
Siemens Healthcare Diagnostics is recalling 10,515 ADVIA Centaur XP Immunoassay Systems because a slight crack may occur in the tubing at the reservoir connector assembly due to mechanical stress.
KC Pharmaceuticals is recalling 302,976 bottles of Eye Drops A.C. because the active ingredient was stored in a non-GMP compliant warehouse in Italy.
Advanced Sterilization Products is recalling STERRAD System cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.
Advanced Sterilization Products is recalling STERRAD 200 cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.
Advanced Sterilization Products is recalling STERRAD 100NX cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.
Stryker Endoscopy is recalling 180,573 Cobra Grasper instruments because the instructions for use do not support specific sterilization methods.
Stryker Endoscopy is recalling 180,573 units of Schertel Forceps because the instructions for use do not support specific sterilization methods.
Stryker Endoscopy is recalling 180,573 units of Debaney Forceps because the instructions for use do not support specific sterilization methods.
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Stryker Endoscopy is recalling 180,573 Hasson Cannula units because the instructions for use do not support specific sterilization methods.
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.