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Recall archive

95,388 stored notices, from Jun 20, 2012 to Nov 11, 2026.

32,343 recalls · page 1 of 1348

Medical devices

In the agency's Nov 11, 2026 enforcement report

Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Accriva Diagnostics, Inc.

FDA (weekly enforcement report)

Medical devices

In the agency's Nov 11, 2026 enforcement report

CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Artivion, Inc.

FDA (weekly enforcement report)

Drugs

In the agency's Nov 11, 2026 enforcement report

Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 50 Tablets (5 x 10) Unit Dose AVPAK, Manufactured for: AvKARE,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

AvKARE

FDA (weekly enforcement report)

Drugs

In the agency's Nov 11, 2026 enforcement report

Tychasis Coats Aloe Lotion (Allantoin 0.5%) packaged in a)0.5 oz, b)8 oz (NDC 70211-704-08), and c)33 oz (NDC…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

BioMed Laboratories, LLC.

FDA (weekly enforcement report)

Medical devices

In the agency's Nov 11, 2026 enforcement report

Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Cardinal Health 200, LLC

6 more products in this recall

FDA (weekly enforcement report)

Medical devices

In the agency's Nov 11, 2026 enforcement report

Generic Name: Edwards Commander M Delivery System Generic Name: Edwards Commander M Delivery System Model/Catalog…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Edwards Lifesciences, LLC

FDA (weekly enforcement report)

Food

In the agency's Nov 11, 2026 enforcement report

Bulk packaged Seitan Cubes; 2/ 5-pound vacuumed seal packages per case. Case is generic brown cardboard with product…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

House Foods America Corporation

FDA (weekly enforcement report)

Medical devices

In the agency's Nov 11, 2026 enforcement report

Nextseq 550Dx Instrument REF: 20005715, FOR IN VITRO DIAGNOSTIC USE

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Illumina, Inc.

2 more products in this recall

FDA (weekly enforcement report)

Medical devices

In the agency's Nov 11, 2026 enforcement report

Embletta MPR PG Multi Parameter Recorder Sleep Monitor, Model/Catalog Number: 2003011

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Natus Medical Incorporated

FDA (weekly enforcement report)

Drugs

In the agency's Nov 11, 2026 enforcement report

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low Magnesium/ Low Calcium and Attached stay safe Exchange…

Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.

NxStage Medical Inc.

FDA (weekly enforcement report)

Food

In the agency's Nov 11, 2026 enforcement report

ParaBien Al Grano with UPC: 0 21425 01513 4

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Pan Pepin, Inc.

FDA (weekly enforcement report)

Drugs

In the agency's Nov 11, 2026 enforcement report

Artificial Tears Lubricant Eye Drops, Visine, Pkg Size: 15, Mfg: Geri-Care: Brooklyn, NY. NDC: 68788-7266-0

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Preferred Pharmaceuticals, Inc.

FDA (weekly enforcement report)

Drugs

In the agency's Nov 11, 2026 enforcement report

Glutathione 200mg/mL (pf) Injection Solution, Rx Only, This is a compounded product by: Premium Health Care Pharmacy…

Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.

Premium Health Care LLC

FDA (weekly enforcement report)

Medical devices

In the agency's Nov 11, 2026 enforcement report

EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM REF72463106

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Smith & Nephew, Inc.

FDA (weekly enforcement report)

Medical devices

In the agency's Nov 11, 2026 enforcement report

Tandem Mobi Insulin Pump, Models: 1004004, 1010750, 1012676, 1012719, 1013655, 1013656, 1013501, 1013700, 1014081,…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Tandem Diabetes Care, Inc.

FDA (weekly enforcement report)

Drugs

In the agency's Nov 11, 2026 enforcement report

Red Blood Cells, Leukocytes Reduced

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Versiti Michigan Inc.

FDA (weekly enforcement report)

Drugs

In the agency's Nov 11, 2026 enforcement report

ALPHA LIPOIC ACID (MDV) 25MG/ML **30ML**, VMC, Victory Medical Center Pharmacy, Austin Texas

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Victory Medical Center Pharmacy

FDA (weekly enforcement report)

Drugs

In the agency's Nov 4, 2026 enforcement report

Palm Antiseptic Hand Soap Net Contents: 1 Gallon (3.8 L). Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr.,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

ABC Compounding Co., Inc.

10 more products in this recall

FDA (weekly enforcement report)

Medical devices

In the agency's Nov 4, 2026 enforcement report

Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Abiomed, Inc.

FDA (weekly enforcement report)

Drugs

In the agency's Nov 4, 2026 enforcement report

Red Blood Cells, Leukocytes Reduced

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

American Red Cross Blood Svcs

FDA (weekly enforcement report)

Drugs

In the agency's Nov 4, 2026 enforcement report

Cyanocobalamin Injection, USP, 1000 mcg/mL, 25 x 1 mL multi-dose vials, Rx only, American Regent INC, Shirley, NY,…

Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.

American Regent, Inc.

FDA (weekly enforcement report)

Medical devices

In the agency's Nov 4, 2026 enforcement report

Carevo, Height-adjustable shower trolley, Model Number BAC1111-01

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

ARJOHUNTLEIGH POLSKA Sp. z.o.o.

FDA (weekly enforcement report)

Medical devices

In the agency's Nov 4, 2026 enforcement report

EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

BioMerieux SA

FDA (weekly enforcement report)

Medical devices

In the agency's Nov 4, 2026 enforcement report

Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Boston Scientific Neuromodulation Corporation

FDA (weekly enforcement report)

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