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.

8876–8900 of 21595

  • ModerateFDA (Devices)·Z-1798-2019·2019-06-26

    Arrowg+ard Blue Advance JACC Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 77 units of Arrowg+ard Blue Advance JACC products because they were labeled with an incorrect expiration date.

    Product
    Arrowg+ard Blue Advance JACC Product Code: CDC 41552 JX1A
    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 (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-1807-2019·2019-06-26

    Arrow International Recalls PICC Catheters Due to Incorrect Expiration Date

    Arrow International Inc is recalling 48 units of Arrowg+ard Blue Advance PICC catheters because the product has an incorrect expiration date.

    Product
    Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 44063 VPS2
    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-1818-2019·2019-06-26

    Arrowg+ard Blue Advance Midline Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling Arrowg+ard Blue Advance Midline devices due to an incorrect expiration date printed on the product.

    Product
    Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
    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 (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 (Drugs)·D-1390-2019·2019-06-26

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

    Sun Pharmaceutical is recalling Wal-Fex D allergy and congestion 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, 20-count box.Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India UPC 3 11917 19453 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1789-2019·2019-06-26

    Arrow PICC Kit Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc is recalling 100 units of Arrow PICC Kits due to an incorrect expiration date printed on the product.

    Product
    Arrow PICC Kit Product Code: ASK 45541 RWJ4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1824-2019·2019-06-26

    Mako Surgical Recalls 2.7 Degree Straight Sagittal Saw Attachments

    Mako Surgical Corporation is recalling 2.7 Degree Straight Sagittal Saw attachments because the bearings were ungreased. The devices were distributed to facilities in 13 US states and three international countries.

    Product
    2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
    Category
    Medical Device
    Distribution
    13 states
  • 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 (Drugs)·D-1450-2019·2019-06-26

    Zydus Recalls Methylprednisolone Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling specific lots of Methylprednisolone tablets due to cross-contamination caused by cleaning failures.

    Product
    METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1806-2019·2019-06-26

    Arrow PICC Catheter Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc. is recalling 162 units of Arrowg+ard Blue Advance PICC catheters due to an incorrect expiration date printed on the product.

    Product
    Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 44052 VPS2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1446-2019·2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 0.5 mg due to cross-contamination caused by a cleaning failure.

    Product
    Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-198-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1453-2019·2019-06-26

    Zydus Recalls Methylprednisolone Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling specific lots of Methylprednisolone tablets due to cross-contamination caused by cleaning failures.

    Product
    METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
    Category
    Drug
    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-1817-2019·2019-06-26

    Arrowg+ard Blue Advance JACC Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 52 units of Arrowg+ard Blue Advance JACC products due to an incorrect expiration date.

    Product
    Arrowg+ard Blue Advance JACC Product Code: JRT 43552 HPHNM
    Category
    Medical Device
    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 (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-1788-2019·2019-06-26

    Arrow PICC Kit Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc. is recalling 105 units of Arrow PICC Kits due to incorrect expiration dates on the packaging.

    Product
    Arrow¿ PICC Kit Product Code: ASK 45541 LVH1
    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 (Drugs)·D-1447-2019·2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling Pramipexole Dihydrochloride Tablets 1 mg due to cross-contamination caused by a cleaning failure.

    Product
    Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16
    Category
    Drug
    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