Severity 1 of 5
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.
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.
Arrow International Inc is recalling Pneumothorax Kits because the product packaging may not be completely sealed.
Arrow International is recalling Large Volume Abdominal Paracentesis Kits because the packaging may not be completely sealed.
Arrow International Inc. is recalling PleuraSeal Thoracentesis Kits because product packaging may not be completely sealed.
Mindray DS USA is recalling 1,719 Gas Module 3 monitoring spirometers because the firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
Keystone Dental Inc is recalling 55 units of plastic abutment sleeves that were packed as non-locking but are actually locking.
PepsiCo is recalling 1,296 cases of Diet Pepsi 12-packs in Arizona due to mislabeling. No illnesses have been reported.
Akorn, Inc. is recalling 24-HOUR Oral Care q4 Kits containing subpotent Chlorhexidine Gluconate Oral Rinse due to product crystallization.
Glenmark Pharmaceuticals is recalling Indomethacin Capsules 50 mg because the bottles display incorrect adult dosage instructions.
PepsiCo is recalling 194 cases of Diet Pepsi Caffeine Free because the outer packaging incorrectly states 'Aspartame Free' while the product contains aspartame.
Renaissance Lakewood, LLC is recalling 1,277 bags of Flucanazole Injection due to superpotent and failed stability specifications.
Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required clinical safety checklists.
OMNIlife science Inc. is recalling 32 Apex Knee System Tibial Baseplates due to an incorrect expiration date on the external packaging.
Akorn, Inc. is recalling 4,128 bottles of Triamcinolone Acetonide Lotion, USP 0.1% due to high impurity levels. The product was distributed nationwide and in Puerto Rico.
Randox Laboratories is recalling 117 kits of Immunoassay Premium Controls because the ACTH component does not meet the stated reconstituted stability claim in the product instructions for use.
Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.
Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.
Medtronic is recalling 58,954 units of Argyle Suction Tubing because some pouches may be incorrectly labeled as Salem Sump Dual Lumen Stomach Tubes.
Stryker is recalling T/Pump temperature therapy pumps because the operations and maintenance manuals incorrectly added a sentence to the Indications for Use statement.
Arrow International Inc is recalling 23,904 AGB+ Pressure Injectable Quad-Lumen CVC Kits because some units are missing stickers containing lot number, expiration date, and UDI information.
Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot number, expiration date, and UDI information.
Arrow International is recalling 23,904 central venous access kits because some units may be missing stickers with lot numbers, expiration dates, and UDI information.
Dr. Reddy's Laboratories is recalling Clocortolone Pivalate Cream, 0.1%, 90-gram tubes because viscosity failed stability specifications.
Arrow International Inc. is recalling 23,904 Arrowg+ard Blue central venous catheters because some units are missing stickers with lot, expiration, and UDI information.
Alva-Amco Pharmacal Companies is recalling Psoriasin Daytime Relief Cream because it failed to maintain its label claim of coal tar throughout its expiry period.
Philips is recalling 4,315 HeartStart XL+ defibrillators in China to update software that improves device readiness information.