Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.

Bridgewater, NJ, US · Updated 9/16/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · device

Wilson-Cook Medical Inc. — Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Des

Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).

Winston Salem, NC, US · Updated 9/16/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · drug

B BRAUN MEDICAL INC — 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.

Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene

Allentown, PA, US · Updated 9/16/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · food

International Sprout Holdings, Inc — Alfalfa, Net Weight 50 lbs. bag, Product of USA, International Specialty Supply 1011 Volunteer Dr. Cookeville, TN 38506

Potential E. coli and Salmonella contamination

Cookeville, TN, US · Updated 9/16/2026, 12:00:00 AM UTC

Source: FDA — food enforcement reference

Reference notice · drug

OurPharma LLC — fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.

Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).

Fayetteville, AR, US · Updated 9/16/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · device

NOXBOX LTD — NOxBOXi Nitric Oxide Delivery System.

Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.

Sittingbourne, US · Updated 9/15/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Straumann USA LLC — GM Helix Implant, REF: 109.984;

There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.

Andover, MA, US · Updated 9/15/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

BD SWITZERLAND SARL — BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015861A 10885403232626 5

Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.

Eysins, US · Updated 9/15/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Medline Industries, LP — Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences…