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All recalls7,869 total

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SUN PHARMACEUTICAL INDUSTRIES INC — Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmac

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.

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Agebox — Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027

Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren

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Agebox — Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0

Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren

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Baxter Healthcare Corporation — Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.

Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.

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Illumina, Inc. — Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5,

An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.

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WFM Purchasing, LP — Whatcom Blue Sliced cheese; Sliced and packaged in deli plastic wrap with Whole Foods Scale labels.

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.

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Pacific International Marketing — Carton Label: PACIFIC FRESH VEGETABLES PACIFIC INTERNATIONAL MARKETING SALINAS, CA 93912 Carton Sticker Label: Conv Italian Parsley 60 Ct Ctn Pacific Product of USA

Potential contamination with Salmonella.

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MAMTAKIM, Inc. — Belevini BICHKI, Dried Salted Whole Smelts, Net. Weight, 5.29 oz (150 g) VACUUM PACK,20 PACKAGES PER CASE, FROZEN, REFRIGERATE AFTER OPENING

Clostridium botulinum (uneviscerated fish)

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Pacific International Marketing — Carton Label: PACIFIC STRAIGHT FROM THE FIELDS FRESH HERBS 4/24 BUNCH ITALIAN PARSLEY BAGS PRODUCE OF U.S.A. PACIFIC INTERNATIONAL MARKETING SALINAS, CA 93912 Carton

Potential contamination with Salmonella.

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Pacific International Marketing — Carton Label: PACIFIC FRESH VEGETABLES PACIFIC INTERNATIONAL MARKETING SALINAS, CA 93912 PRODUCE OF U.S.A. Sticker Label: Conv Italian Parsley 30 Ct Iceless Pacific

Potential contamination with Salmonella.

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MAMTAKIM, Inc. — Belevini KORUSHKA, Dried Salted Whole Smelts, Net. Weight, 5.29 oz (150 g) VACUUM PACK, 20 PACKAGES PER CASE, FROZEN, REFRIGERATE AFTER OPENING

Clostridium botulinum (uneviscerated fish)

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WFM Purchasing, LP — Whatcom Farmhouse- Sliced and packaged in deli plastic wrap with Whole Foods Scale labels.

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.

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Pacific International Marketing — Carton Label: PACIFIC FRESH VEGETABLES PACIFIC INTERNATIONAL MARKETING SALINAS, CA 93912 Carton Sticker Label: Conv Italian Parsley 60 Ct Iceless Pacific Product of

Potential contamination with Salmonella.

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Winder Laboratories, LLC — Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS UPC 3 15826 16910 2; NDC 75826-171-10 1mg 100 TABLETS UPC 3 15826 17110 5 Ma

Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.

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Otsuka ICU Medical LLC — 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

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

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Medline Industries, LP — Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS

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.

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Medline Industries, LP — Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QS

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.

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Medline Industries, LP — Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25500QS

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.

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Medline Industries, LP — Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON256133QS

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.

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Philips North America — Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM

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.

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Medline Industries, LP — CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930F

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.

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Medline Industries, LP — Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3", Medline Item Number CUR1930P

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.

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Medline Industries, LP — MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C

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.

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Nipro Medical Corporation — Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only

Screw may loosen or fallout of Hemodialysis system

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Medline Industries, LP — Quick Strip Plastic Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25600QS

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.

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Peterson Company Inc — Item# 29608 Farmhouse White, Twin Sisters Creamery brand, product is packed in Cryovac and each package weighs 5oz-6oz. This cheese is made from raw milk. Ingredients: cultured

Item #29608 Farmhouse White is recalled due to E. coli O103:H2.

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Peterson Company Inc — Item# 28855 Whatcom Blue, Twin Sisters Creamery brand, product is packed in Cryovac and each package weighs 5oz-6oz. There are 16 pieces per case. This cheese is made from raw

Item #28855 Whatcom Blue is recalled due to E. coli O103:H2

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Fresenius Medical Care Holdings, Inc. — 5008X CAREsystem +CLiC +CDX;

Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.

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Twin Sisters Creamery, LLC — Twin Sisters Creamery Whatcom Blue cheese, 2.5lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: cultured raw cow's milk, salt, enzyme

Raw milk Whatcom Blue cheese is recalled due to E. coli O103:H2.

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Twin Sisters Creamery, LLC — Twin Sisters Creamery Mustard Seed cheese, 3lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: Cultured raw cow's milk, salt, whole ye

Raw milk Mustard Seed cheese is recalled due to E. coli O103:H2 and E. coli O74:H25.

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Water Pure, Inc. — My Bladder; Supports normal bladder tone & control; Dietary Supplement; packaged in white HDPE bottle with a white cap; bottle size is 150 CC; the net contents in 60 clear capsules

Product may be contaminated with E. coli O7:K1 (IAI39/ExPEC) and E. coli 1303

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MeriCal, LLC — Member's Mark Super Greens Dietary Supplement; 48 servings; Net Weight 18.28 oz (518.4g) UPC: 193968490775

Potential contamination of Salmonella Richmond

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Twin Sisters Creamery, LLC — Twin Sisters Creamery Farmhouse Cheese, 3lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: cultured raw cow's milk, salt, and enzymes

Raw milk Farmhouse cheeses are recalled due to E. coli O103:H2 and E. coli O74:H25.

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E.A. Sween Co. — Deli Express BBQ Pulled Pork on a sesame bun. Net Wt 5.5oz (156g) UPC 0 41433-03087 5. EA Sween Company, Eden Prairie, MN 55344.

Potential foreign material (plastic)

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Good Way Trading Group Inc — BaiLiFeng Dried Cinnamon Powder; Net Wt 4 oz/114G; Good Way Trading Group Inc 58-51 Maspeth Avenue Maspeth NY 11378; Product of China; Ingredients: Dried Cinnamon; UPC cod

contains high levels of lead (10.7 mg/kg)

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Twin Sisters Creamery, LLC — Twin Sisters Creamery Peppercorn cheese, 3lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: cultured raw cow's milk, whole peppercorn

Raw milk Peppercorn cheese is recalled due to E.coli O26:H11

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Cipla USA, Inc. — Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for :

Failed stability specifications: Out of specification for hardness test

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Cipla USA, Inc. — Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY

Failed stability specifications: Out of specification for hardness test

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Edan Diagnostics — Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform lo

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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Siemens Medical Solutions USA, Inc — MAMMOMAT Inspiration;

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

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Edan Diagnostics — Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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Siemens Medical Solutions USA, Inc — MAMMOMAT Fusion;

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

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Edan Diagnostics — Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time con

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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Edan Diagnostics — Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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Edan Diagnostics — Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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Edan Diagnostics — Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monit

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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GE Medical Systems, LLC — Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).

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Edan Diagnostics — Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care prof

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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Siemens Medical Solutions USA, Inc — MAMMOMAT Revelation;

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

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Edan Diagnostics — Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

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