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.

16176–16200 of 21645

  • ModerateFDA (Devices)·Z-2074-2015·2015-07-22

    Nobel Biocare Recalls Zirconia Abutment Retrieval Instruments Due to Dimensional Error

    Nobel Biocare is recalling 149 units of Zirconia Abutment Retrieval Instruments and Kits because a dimensional error prevents the instruments from removing metal adapters as intended.

    Product
    Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2844-2015·2015-07-22

    Sysco Mandarin Oranges Recalled for Carbendazim Residue

    Sysco Corporation is recalling 292 cases of Whole Segments Mandarin Oranges in Light Syrup because the product tested positive for Carbendazim.

    Product
    Sysco International Whole Segments Mandarin Oranges In Light Syrup Net Wt. 6 LB 10 OZ (3.01 kg) NDC: 074865629065; 6 cans per case
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2087-2015·2015-07-22

    Eizo RadiForce GX540 Monitors Recalled for Display Abnormalities

    Eizo is recalling 19 RadiForce GX540 monitors that may display abnormally when connected to specific graphics boards with DisplayPort.

    Product
    RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2091-2015·2015-07-22

    Synthes Recalls Helical Blade Inserter for TFNA Due to Sizing Defect

    Synthes (USA) Products LLC is recalling 32 units of the Helical Blade Inserter for TFNA because an oversized pin prevents the tool from passing through the guide sleeve.

    Product
    Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2023-2015·2015-07-15

    Stradis Healthcare Recalls Eye Packs Containing Recalled Devon Light Gloves

    Stradis Healthcare is recalling Eye Packs containing Devon Light Gloves due to a manufacturer recall of the glove component by Medtronic.

    Product
    Eye Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2789-2015·2015-07-15

    DASANI Purified Water Recalled for Potential Plastic Fragments

    World of Coca-Cola is recalling DASANI Purified Water because some bottles may contain linear pieces of plastic from the production process.

    Product
    DASANI Purified Water, 24/20 fl. oz. (1.25 pt) 591 mL, pack, Desani, The Coca Cola Company, Atlanta, GA 30313.
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-2021-2015·2015-07-15

    Stradis Gyn Pack Recalled Due to Medtronic Component Recall

    Stradis Healthcare is recalling Gyn Packs containing Devon Light Gloves because the manufacturer, Medtronic, recalled the glove component.

    Product
    Gyn Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2019-2015·2015-07-15

    Stradis Healthcare Recalls Abdominal Packs Containing Recalled Devon Light Gloves

    Stradis Healthcare is recalling Abdominal Packs and Abdom Packs because they contain Devon Light Gloves, a component recalled by Medtronic.

    Product
    Abdominal Pack and Abdom Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2012-2015·2015-07-15

    Stradis ACL Pack Recalled Due to Component Glove Recall

    Stradis Healthcare is recalling ACL Packs containing Devon Light Gloves because the manufacturer, Medtronic, is recalling the glove component.

    Product
    ACL Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2017-2015·2015-07-15

    Stradis Healthcare Recalls Bariatric Packs Containing Recalled Devon Light Gloves

    Stradis Healthcare is recalling Bariatric Packs because they contain Devon Light Gloves that are subject to a separate manufacturer recall by Medtronic.

    Product
    Bariatric Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1995-2015·2015-07-15

    Stradis Vein Surgery Packs Recalled Due to Component Issue

    Stradis Healthcare is recalling 55 vein surgery packs because they contain a Devon Light Glove component subject to a separate recall by Medtronic.

    Product
    Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1230-2015·2015-07-15

    Zonisamide capsules recalled for inadequate complaint investigation

    American Health Packaging is recalling Zonisamide capsules due to current good manufacturing practice deviations involving inadequate investigation of customer complaints.

    Product
    Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11); 5 blister packs per carton (NDC 68084-008-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2008-2015·2015-07-15

    Stradis Mississippi Pack Recalled Due to Medtronic Component Recall

    Stradis Healthcare is recalling Mississippi Packs containing Devon Light Gloves due to a manufacturer recall of the glove component.

    Product
    Mississippi Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2015-2015·2015-07-15

    Stradis Healthcare Recalls Skin and Vein Packs Containing Recalled Gloves

    Stradis Healthcare is recalling Skin and Vein Packs because they contain Devon Light Gloves that Medtronic is recalling.

    Product
    Skin and Vein Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2044-2015·2015-07-15

    Volcano Intravascular Ultrasound System Recalled for Interoperability Limitation

    Volcano Corp is recalling 227 Intravascular Ultrasound Imaging and Pressure Systems due to a limitation in interoperability with the Philips Xper Flex Cardia system that may impact Fraction Flow Reserve calculations.

    Product
    Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1226-2015·2015-07-15

    American Health Packaging Recalls Lisinopril Tablets Due to CGMP Deviations

    American Health Packaging is recalling 4,718 cartons of Lisinopril 5mg tablets due to inadequate investigation of customer complaints.

    Product
    Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11); 10 blister packs per carton (NDC 68084-060-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2053-2015·2015-07-15

    RTI Surgical Recalls Songer Spinal Cable System Due to Labeling Error

    RTI Surgical is recalling 25 units of the Songer Spinal Cable System because the box end label incorrectly identifies the material as Titanium instead of Stainless Steel.

    Product
    Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2043-2015·2015-07-15

    Volcano Intravascular Ultrasound System Recalled for Interoperability Limitation

    Volcano Corp is recalling 227 intravascular ultrasound systems due to a limitation that may affect Fraction Flow Reserve calculations when connected to specific Philips monitors.

    Product
    Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2025-2015·2015-07-15

    Stradis Healthcare Recalls Shoulder Packs Containing Recalled Devon Light Gloves

    Stradis Healthcare is recalling surgical shoulder packs because they contain Devon Light Gloves that are subject to a separate manufacturer recall by Medtronic.

    Product
    Shoulder Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1225-2015·2015-07-15

    Famotidine tablets recalled for inadequate complaint investigation

    American Health Packaging is recalling 97,837 cartons of Famotidine tablets 20mg due to CGMP deviations involving inadequate investigation of customer complaints.

    Product
    Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11); 10 blister packs per carton (NDC 68084-172-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2007-2015·2015-07-15

    Stradis Surgical Packs Recalled Due to Medtronic Glove Component Issue

    Stradis Healthcare is recalling surgical and general surgery packs because they contain Devon Light Gloves, a component being recalled by Medtronic.

    Product
    Surgical Pack and General Surgery Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1217-2015·2015-07-15

    Mylan Recalls Capecitabine Tablets Due to Dissolution Failures

    Mylan Pharmaceuticals is recalling 1,068 bottles of Capecitabine Tablets, 500 mg, because the product failed to meet dissolution specifications.

    Product
    Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6.
    Category
    Drug
    Distribution
    Distributed nationwide