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Medical Device
FDA DevicesClass II

DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog ...

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

May 13, 2026Katalyst Surgical, LLC
Medical Device
FDA DevicesClass II

DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Numb...

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

May 13, 2026Katalyst Surgical, LLC
Medical Device
FDA DevicesClass II

Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; ...

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

May 13, 2026Medline Industries, LP
Food & Beverage
FDA FoodClass II

Woodstock Organic Shelled Edamame 10 oz. and 48 oz.

Foreign object: metal pieces

May 13, 2026Green Organic Vegetables
Medical Device
FDA DevicesClass II

One Step pH in vitro diagnostic test REF: 31I4P

The devices were distributed without required FDA premarket clearance or approval.

May 13, 2026DFI Co., Ltd.
Food & Beverage
FDA FoodClass II

Dark Pecan Creamed Honey/Pecan Creamed Honey 671333101407 * These product labels...

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

May 13, 2026Walker Honey Co
Medical Device
FDA DevicesClass II

Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DEL...

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

May 13, 2026Medline Industries, LP
Medical Device
FDA DevicesClass II

Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervic...

Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.

May 13, 2026Centinel Spine, Inc.
Medical Device
FDA DevicesClass II

Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0...

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

May 13, 2026Medline Industries, LP
Medical Device
FDA DevicesClass II

Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT G...

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

May 13, 2026Medline Industries, LP
Pharmaceutical
FDA DrugsClass II

TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag,...

Incorrect Product Formulation: product did not contain insulin as listed in the label.

May 13, 2026Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
Medical Device
FDA DevicesClass II

ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

Resorbable bone void filler falls outside standard specifications.

May 13, 2026Orthorebirth Co Ltd
Food & Beverage
FDA FoodClass II

Loard's Strawberry Ice Cream - 32 oz; 56 oz

Undeclared Milk, Red #40.

May 13, 2026Silver Moon LP dba Loard's Ice Cream
Medical Device
FDA DevicesClass II

BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

Contamination to in-vitro diagnostic test may result in false positives.

May 13, 2026BioFire Diagnostics, LLC
Medical Device
FDA DevicesClass II

Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B...

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

May 13, 2026Medline Industries, LP
Medical Device
FDA DevicesClass II

Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) AR...

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

May 13, 2026Medline Industries, LP
Medical Device
FDA DevicesClass II

Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; ...

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

May 13, 2026Medline Industries, LP
Medical Device
FDA DevicesClass II

Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410;...

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

May 13, 2026Medline Industries, LP
Medical Device
FDA DevicesClass II

See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVE...

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

May 13, 2026Medline Industries, LP
Medical Device
FDA DevicesClass II

ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Source...

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.

May 13, 2026Erbe Medical, LLC
Medical Device
FDA DevicesClass I

Halyard CATH LAB kit. Model Number: SACL75AM.

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

May 13, 2026AVID Medical, Inc.
Food & Beverage
FDA FoodClass II

Loard's Champagne Sherbert - 32 oz

Undeclared Milk, Red #40.

May 13, 2026Silver Moon LP dba Loard's Ice Cream
Food & Beverage
FDA FoodClass I

Costco Service Deli Department 63 MEATLOAF SEASONING MORE FLV Pack Size: 4-5lb. ...

Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.

May 13, 2026Griffith Foods Inc.
Food & Beverage
Germany BVLGeneral Alert

Vom Land Heidelbeerkonfitüre Extra, 450 Gramm

Fremdkörper

May 13, 2026Zentis GmbH & Co. KG, Jülicher Straße 177, 52070 Aachen
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