The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

8851–8875 of 21595

  • ModerateFDA (Drugs)·D-1389-2019·2019-06-26

    Sun Pharmaceutical Recalls Wal-Fex D Tablets Due to Impurity Testing Failures

    Sun Pharmaceutical is recalling Wal-Fex D tablets because testing showed impurity levels above or near specification limits.

    Product
    Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, USP, Allergy & Congestion, 30-count box. Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India. UPC 3 11917 19454 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1791-2019·2019-06-26

    Arrow PICC Kit Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc is recalling 1,840 units of Arrow PICC Kits because the product labels display an incorrect expiration date.

    Product
    Arrow PICC Kit Product Code: ASK 45552 RWJ4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1840-2019·2019-06-26

    LEEP Precision Integrated System Recalled for Incorrect Fuse Installation

    CooperSurgical is recalling 19 LEEP Precision Integrated Systems because incorrect fuses may have been installed in the generator.

    Product
    LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1793-2019·2019-06-26

    Arrow PICC Recall Due to Incorrect Expiration Date Labeling

    Arrow International Inc is recalling 108 units of Arrow PICC with Chloraguard Technology because the product was labeled with an incorrect expiration date.

    Product
    Arrow PICC with Chlorag+ard Technology Product Code: CDA 45041 HPK1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1801-2019·2019-06-26

    Arrowg+ard Blue Advance JACC Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling Arrowg+ard Blue Advance JACC products due to an incorrect expiration date. The recall involves 174 units distributed nationwide.

    Product
    Arrowg+ard Blue Advance JACC Product Code: CDC 42063 JX1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1809-2019·2019-06-26

    Arrow International Recalls PICC Catheters Due to Incorrect Expiration Date

    Arrow International is recalling 350 units of Arrowg+ard Blue Advance PICC catheters because the product labels display an incorrect expiration date.

    Product
    Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45063 HPK1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1790-2019·2019-06-26

    Arrow PICC Kit Recall Issued for Incorrect Expiration Date Labeling

    Arrow International Inc. is recalling 190 units of Arrow PICC Kits due to incorrect expiration dates printed on the product.

    Product
    Arrow PICC Kit pre loaded with Arrow¿ VPS Precision Stylet Product Code: ASK 45552 CRM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1820-2019·2019-06-26

    Arrow PICC Catheters Recalled for Incorrect Expiration Date Labeling

    Arrow International is recalling 991 units of Arrow PICC with Chloraguard Technology due to incorrect expiration dates on the product.

    Product
    Arrow¿ PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1388-2019·2019-06-26

    Sun Pharmaceutical Recalls Allergy Relief D Tablets Due to Impurities

    Sun Pharmaceutical is recalling Allergy Relief D tablets because testing showed impurities above or near specification limits.

    Product
    Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 43023 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1795-2019·2019-06-26

    Arrow PICC Recall Issued for Incorrect Expiration Date Labeling

    Arrow International Inc is recalling 20 units of Arrow PICC with Chlorag+ard Technology due to an incorrect expiration date on the label.

    Product
    Arrow PICC with Chlorag+ard Technology Product Code: CDA 45541 HPK1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1449-2019·2019-06-26

    Zydus Recalls Methylprednisolone Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling Methylprednisolone tablets due to cross-contamination caused by cleaning failures. The affected lots are distributed nationwide.

    Product
    METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1845-2019·2019-06-26

    Zimmer Biomet Recalls Mobi-C Distraction Screws Due to Labeling Error

    Zimmer Biomet is recalling 313 Mobi-C 14mm Distraction Screws because they were incorrectly labeled as 12mm length screws.

    Product
    Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The device is intende
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1812-2019·2019-06-26

    Arrow JACC Medical Device Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc is recalling 2 units of Arrow JACC with Chloraguard Technology due to an incorrect expiration date on the product label.

    Product
    Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1849-2019·2019-06-26

    Stryker Endotrac Hook/Triangle Blade Kit Recall Due to Seal Integrity

    Stryker GmbH is recalling 1,600 Endotrac EPF/EGR Hook/Triangle Blade Kits because the sterile bag seal integrity may be compromised.

    Product
    Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1799-2019·2019-06-26

    Arrowg+ard Blue Advance JACC Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling Arrowg+ard Blue Advance JACC products due to an incorrect expiration date listed by Lidstock.

    Product
    Arrowg+ard Blue Advance JACC Product Code: CDC 42041 JX1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1800-2019·2019-06-26

    Arrowg+ard Blue Advance JACC recalled for incorrect expiration date

    Arrow International Inc is recalling 84 units of Arrowg+ard Blue Advance JACC due to incorrect expiration dates.

    Product
    Arrowg+ard Blue Advance JACC Product Code:CDC 42052 JX1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1811-2019·2019-06-26

    Arrowg+ard Blue Advance PICC Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling 450 units of Arrowg+ard Blue Advance PICC devices due to incorrect expiration dates.

    Product
    Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1803-2019·2019-06-26

    Arrow JACC Central Catheter Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling 191 units of JACC central catheters because the expiration date printed on the product is incorrect.

    Product
    Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillo subclavian Central Catheter Product Code: CDC 42563 JX1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1810-2019·2019-06-26

    Arrow International Recalls PICC Catheters Due to Incorrect Expiration Date

    Arrow International Inc is recalling 279 units of Arrowg+ard Blue Advance PICC catheters because the products display an incorrect expiration date.

    Product
    Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45063 VPS2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1792-2019·2019-06-26

    Arrow PICC Recall Due to Incorrect Expiration Date Labeling

    Arrow International Inc is recalling 180 units of Arrow PICC with Chlorag+ard Technology because the products bear an incorrect expiration date.

    Product
    Arrow PICC with Chlorag+ard Technology Product Code: CDA 44052 HPK1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1814-2019·2019-06-26

    Arrow JACC Medical Device Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling Arrow JACC devices with Chloraguard Technology due to an incorrect expiration date on the packaging.

    Product
    Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42541 HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1765-2019·2019-06-26

    Teleflex Recalls Sheridan/CF Novaplus Tracheal Tubes Due to Connector Issues

    Teleflex Medical is voluntarily recalling specific lots of Sheridan/CF Novaplus 7.0 mm tracheal tubes because the 15 mm Sheridan connector may disconnect from the tube.

    Product
    Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1764-2019·2019-06-26

    Teleflex Recalls Sheridan Tracheal Tubes Due to Connector Disconnection

    Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan tracheal tubes because the 15 mm connector may disconnect from the tube.

    Product
    Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0 mm, Product Code 5-10316 6) HVT 8.5 mm, Product Code 5-10317 Product Usage: Tracheal tube/airw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1805-2019·2019-06-26

    Arrow PICC with Chloraguard Technology Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 135 units of Arrow PICC with Chloraguard Technology due to an incorrect expiration date.

    Product
    Arrow¿ PICC with Chlorag+ard Technology Product Code: CDC 44052 HPK1A
    Category
    Medical Device
    Distribution
    Distributed nationwide