Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

Class IIModerate

FDAOct 28, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Medline Perfusion Syringe (Unknown) – BD Luer Tip Cap Issue (2025)

Laceration Risk

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe.

Low

FDAOct 27, 2025Nationwide

CURAD Germ-Shield Bandages (Medline) – Packaging Seal Compromise (2025)

Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

Low

FDAOct 27, 2025Nationwide

Azurion R3.0 (Philips) – SSD Spacer Omission (2025)

Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.

Moderate

FDAOct 27, 2025Nationwide• Philips North America

Hemodialysis System Surdial DX (Nipro) – Screw Loosening Risk (2025)

Screw may loosen or fallout of Hemodialysis system

Moderate

FDAOct 27, 2025Nationwide• Nipro Medical Corporation

Quick Strip Fabric Bandages (Medline) – Packaging Seal Compromise (2025)

Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

Low

FDAOct 27, 2025Nationwide

Quick Strip Adhesive Bandages (Medline) – Packaging Seal Compromise (2025)

Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

Low

FDAOct 27, 2025Nationwide

Fur Friends Adhesive Bandages (Medline) – Packaging Seal Compromise (2025)

Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

Low

FDAOct 27, 2025Nationwide

Belevini Korushka Smelts (MAMTAKIM) – Botulinum Risk (2025)

Clostridium botulinum (uneviscerated fish)

Class IHigh

FDAOct 27, 2025FL, NJ, NY +2 more• MAMTAKIM, Inc.

Belevini Bichki Smelts (MAMTAKIM) – Botulinum Risk (2025)

Clostridium botulinum (uneviscerated fish)

Class IHigh

FDAOct 27, 2025FL, NJ, NY +2 more• MAMTAKIM, Inc.

Vegetable Carton Label (Pacific International) – Salmonella Risk (2025)

Salmonella

Potential contamination with Salmonella.

Class IHigh

FDAOct 27, 2025AZ, CA, FL +5 more• Pacific International Marketing

Vegetable Carton Label (Pacific International) – Salmonella Risk (2025)

Salmonella

Potential contamination with Salmonella.

Class IHigh

FDAOct 27, 2025AZ, CA, FL +5 more• Pacific International Marketing

Fresh Herbs (Pacific International) – Salmonella Risk (2025)

Salmonella

Potential contamination with Salmonella.

Class IHigh

FDAOct 27, 2025AZ, CA, FL +5 more• Pacific International Marketing

Whatcom Blue Cheese (WFM Purchasing) – E. coli Contamination (2025)

E. coli

Twin Sisters Creamery's recall of cheese products due to WSDA testing that identified potential STEC and E. coli O103 contamination. Whole Foods Market received affected products through distributor Peterson Company and sold them by weight with store-generated labels.

Class IHigh

FDAOct 27, 2025OR, WA• WFM Purchasing, LP

Sodium Chloride Injection (Otsuka) - Sterility Risk (2025)

Lack of Assurance of Sterility: Potential for flexible container leaks.

Class IIModerate

FDAOct 27, 2025Nationwide• Otsuka ICU Medical LLC

Whatcom Farmhouse Cheese (WFM Purchasing) – E. coli Contamination (2025)

E. coli

Class IHigh

FDAOct 27, 2025OR, WA• WFM Purchasing, LP

Curad Quick Strip Bandages (Medline) – Packaging Seal Compromise (2025)

Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

Low

FDAOct 27, 2025Nationwide

Vegetable Carton Label (Pacific International) – Salmonella Risk (2025)

Salmonella

Potential contamination with Salmonella.

Class IHigh

FDAOct 27, 2025AZ, CA, FL +5 more• Pacific International Marketing

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