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.

251–275 of 21708

  • ModerateFDA (Devices)·Z-3097-2026·2026-09-09

    Cardinal Health Recalls Urinary Catheter Trays with Contaminated Wipes

    Cardinal Health is recalling 115 units of urinary catheter trays containing CliniClean Pericare Wipes that may be contaminated with manufacturing lubricant.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,ROBOTICS DH , Catalog Number: PGOCRDNHD; 2) KIT, EAS ROBOTIC , Catalog Number: PG36RPEAB; 3) KIT, VIDEO THORACOSCOPY CMC , Catalog Number: PVCGVTACF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3098-2026·2026-09-09

    Cardinal Health Recalls Urinary Catheter Trays with Potentially Contaminated Wipes

    Cardinal Health is recalling 2,448 urinary catheter trays containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant, posing a risk of localized skin irritation.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG540; 2) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG542; 3) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG55I…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1325-2026·2026-09-09

    Wonton Specialist Cooked Noodle Recalled for Undeclared Red Dye

    Wonton Specialist is recalling 700 bags of cooked noodles in New York, New Jersey, and Pennsylvania due to undeclared FD&C Red No. 40.

    Product
    Wonton Specialist Inc. Cooked Noodle, 16 oz and 5 lb - packaged in clear plastic bags
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0825-2026·2026-09-09

    Allies Group Recalls Subpotent Sunscreen Gel Due to Inadequate SPF Protection

    Allies Group Inc. is recalling specific lots of THE ONE SPF 50 Invisible Sunscreen Gel because testing showed the product may not provide the labeled SPF 50 protection.

    Product
    THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 074733
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0826-2026·2026-09-09

    Allies Group Recalls Subpotent SPF 50 Sunscreen Gel

    Allies Group Inc. is recalling 2,149 tubes of SPF 50 sunscreen gel because testing showed it may not provide the labeled sun protection.

    Product
    THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 075853
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3047-2026·2026-09-09

    Diagnostica Stago Recalls STA Staclot Protein S Reagent Due to QC Drift

    Diagnostica Stago is recalling 5,220 units of STA Staclot Protein S reagent because quality control values drifted within the stated stability period.

    Product
    STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3102-2026·2026-09-09

    Cardinal Health Recalls Urinary Catheter Trays with Contaminated Wipes

    Cardinal Health is recalling specific urinary catheter trays containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM3; 2) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM4; 3) KIT, C SECTION , Catalog Number: PLVMCS22G…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3099-2026·2026-09-09

    Cardinal Health Recalls Urinary Catheter Trays with Contaminated Wipes

    Cardinal Health is recalling 60 units of urinary catheter trays containing CliniClean Pericare Wipes that may be contaminated with manufacturing lubricant.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number: PWV2MF01D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0812-2026·2026-09-09

    Baxter Recalls Pantoprazole Sodium Infusion Bags Due to Manufacturing Deviations

    Baxter Healthcare is voluntarily recalling specific lots of Pantoprazole Sodium infusion bags due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0830-2026·2026-09-09

    Mylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures

    Mylan Pharmaceuticals is recalling Mycophenolate Mofetil for injection because it failed to meet dissolution specifications.

    Product
    MYCOPHENOLATE MOFETIL — MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1321-2026·2026-09-09

    Wonton Noodle Recalled for Undeclared FD&C Red No. 40

    Wonton Specialists is recalling 550 bags of Wonton Noodle in New York, New Jersey, and Pennsylvania due to undeclared FD&C Red No. 40.

    Product
    Wonton Specialist Inc. Wonton Noodle, 12 oz - packaged in foam tray overwrapped with clear plastic and 5lb - packaged in clear plastic bags
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-3094-2026·2026-09-09

    Cardinal Health Recalls Presource Packs with Potential Lubricant Contamination

    Cardinal Health is recalling Presource Packs containing CliniClean Pericare Wipes due to potential lubricant contamination that may cause localized skin effects.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH , Catalog Number: PBOCGLN17
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3101-2026·2026-09-09

    Cardinal Health Recalls Presource Packs with Potentially Contaminated Wipes

    Cardinal Health 200, LLC is recalling 1,398 Presource Packs containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, BLO ROBOTIC GYN , Catalog Number: PBCGRGB28; 2) KIT , GYN MAJOR BARNES JEWIS, Catalog Number: PBVMLP22G; 3) KIT, GYN OPERATIVE LAPAROSCOPY, Catalog Number: PBVM0722D…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3030-2026·2026-09-02

    Fujifilm Synapse PACS Software Recalled for Inaccurate Ruler Measurements

    Fujifilm is recalling Synapse PACS software v7.4.310 because a software issue may cause ruler measurements to be inaccurate.

    Product
    FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0789-2026·2026-09-02

    Lupin Recalls Clobetasol Propionate Cream for Content Uniformity Failures

    Lupin Pharmaceuticals is recalling Clobetasol Propionate Cream 0.05% because it failed content uniformity specifications. The recall covers 5,082 tubes distributed nationwide.

    Product
    CLOBETASOL PROPIONATE — CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3018-2026·2026-09-02

    ConMed Suture Anchor Recalled for Incorrect Patient Implant Card

    ConMed is recalling specific suture anchors because they may contain incorrect patient implant cards, which could lead to incorrect device identification and traceability.

    Product
    CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 metric) Hi-Fi Sutures Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3035-2026·2026-09-02

    Olympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling

    Olympus is recalling 335 PowerSeal 5 mm Sealer & Divider devices because the outer shelf box is incorrectly labeled as a 37-cm device.

    Product
    POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3002-2026·2026-09-02

    American Contract System Convenience Kits Recalled for Performance Failures

    American Contract Systems Inc is recalling 30 units of Convenience Kits because Medline catheters failed performance specifications.

    Product
    American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3009-2026·2026-09-02

    AVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency

    AVID Medical is recalling 120 Halyard Total Joint kits because the labeling fails to identify that the statlock component contains natural rubber latex.

    Product
    Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0831-2026·2026-09-02

    Hikma Recalls Ramipril Capsules Due to Process Impurity

    Hikma Pharmaceuticals is recalling specific lots of Ramipril 10 mg capsules because they failed impurity specifications for dicyclohexylurea.

    Product
    RAMIPRIL — RAMIPRIL (RAMIPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3011-2026·2026-09-02

    Halyard Total Joint Kits Recalled for Latex Labeling Deficiency

    AVID Medical is recalling 78 Halyard Total Joint kits because the labeling fails to identify that the statlock component contains natural rubber latex.

    Product
    Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3008-2026·2026-09-02

    AVID Medical Recalls Halyard Total Joint Kits Due to Latex Labeling Error

    AVID Medical is recalling 78 Halyard Total Joint kits because the labeling fails to identify that the statlock component contains natural rubber latex.

    Product
    Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0804-2026·2026-09-02

    Apotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing

    Apotex Corp. is recalling 6,972 bottles of Paxil CR 37.5mg tablets because the product failed dissolution specifications and 24-month stability testing.

    Product
    Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3
    Category
    Drug
    Distribution
    Distributed nationwide