Recall Firm Index

A no-JavaScript index of recalling firms found in the latest Recall Radar openFDA snapshot. Use it when the firm name is the clue you remember from a label, bottle, notice, or device paperwork. When product or brand text is the stronger clue, use the product clue index. When lot, model, serial, UPC, or expiration text is the stronger clue, use the code clue index. When the FDA problem description is the stronger clue, use the reason clue index. When distribution text is the stronger clue, use the location clue index.

GeneratedSep 7, 2026, 6:36 PM EDT
Firms19
Loaded Records36
Class I Firms3
1 loaded record 1 Class I 0 ongoing Food

H & U Inc. dba Sun Noodle

Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net wt. 15...

  • Food: Soba sauce packet, which contains bonito, sardine, and mackerel (fish), was packed into Sura Tanmen Hot and Sour Flavor ramen noodle package... openFDA source
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8 loaded records 0 Class I 8 ongoing Drugs

ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured... | Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured... | Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured... | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufacture... | Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 167... | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured... | Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729... | Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured fo...

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6 loaded records 0 Class I 6 ongoing Devices

Medline Industries, LP

Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Pr... | Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATI... | Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, M... | Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2)... | Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR... | Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2...

  • Devices: Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier ma... openFDA source
  • Devices: Kits contain a potentially contaminated component which were recalled by the manufacturer openFDA source
  • Devices: Kits contain a potentially contaminated component which were recalled by the manufacturer openFDA source
  • Devices: Kits contain a potentially contaminated component which were recalled by the manufacturer openFDA source
  • Devices: Kits contain a potentially contaminated component which were recalled by the manufacturer openFDA source
  • Devices: Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled d... openFDA source
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4 loaded records 0 Class I 4 ongoing Food

Dreyer's Grand Ice Cream Inc.

Outshine Fruit Bars Strawberry, 6-Count 2.5 ounce, with UPC 041548610047, packaged in paper out... | Outshine Fruit Bar Watermelon, 6-Count 2.5 ounce with UPC 041548413624, packaged in paper outer... | Outshine Fruit Bars Grape, 6-Count 2.5 ounce, with UPC 041548244044, packaged in paper outer ca... | Outshine Fruit Bars Black Cherry, 6 Bars, 2.5 ounce, with UPC 041548000121, packaged in paper o...

  • Food: Foreign object: products may contain glass pieces openFDA source
  • Food: Foreign object: products may contain glass pieces openFDA source
  • Food: Foreign object: products may contain glass pieces openFDA source
  • Food: Foreign object: products may contain glass pieces openFDA source
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2 loaded records 0 Class I 2 ongoing Devices

IMRIS Imaging Inc

ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part... | ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 1...

  • Devices: The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning... openFDA source
  • Devices: The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning... openFDA source
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2 loaded records 0 Class I 2 ongoing Food

Lidl US TRADING

ERIDANOUS GREEK STYLE Shortbread Cookies with Chocolate Truffle Coating & Apricot Filling. Prod... | ERIDANOUS GREEK STYLE Shortbread Cookies with apricot filling and cocoa topping with coconut sp...

  • Food: The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared w... openFDA source
  • Food: The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared w... openFDA source
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1 loaded record 0 Class I 1 ongoing Food

Africando Foods LLC

Clear glass bottle with black screw lid with multi label which reads in part as "***AFRICANDO F...

  • Food: Labeling, wheat not listed as sub ingredient of chicken bouillon (minor ingredient), and soybean oil missing from ingredient list openFDA source
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1 loaded record 0 Class I 1 ongoing Devices

Canon Medical System, USA, INC.

Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluorosco...

  • Devices: Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loos... openFDA source
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1 loaded record 0 Class I 1 ongoing Drugs

Church & Dwight Co., Inc.

Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swa...

  • Drugs: CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing openFDA source
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1 loaded record 0 Class I 1 ongoing Devices

Fresenius Medical Care Renal Therapies Group, LLC

Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.

  • Devices: Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms... openFDA source
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1 loaded record 0 Class I 1 ongoing Drugs

Hikma Pharmaceuticals USA INC.

Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsule...

  • Drugs: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). openFDA source
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1 loaded record 0 Class I 1 ongoing Devices

Olympus Corporation of the Americas

POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / El...

  • Devices: Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. openFDA source
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