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.

20051–20075 of 21633

  • ModerateFDA (Devices)·Z-1983-2013·2013-08-28

    Gyrus Medical Recalls Sterile Bipolar Dissecting Forceps Due to Seal Failure

    Gyrus Medical is recalling 1,140 sterile bipolar dissecting forceps units because accelerated aging tests showed a compromised sterile packaging seal.

    Product
    GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1839-2013·2013-08-28

    Galveston Shrimp Company Recalls Frozen Shrimp Due to Foreign Material

    Galveston Shrimp Company is recalling specific lots of frozen shrimp due to the presence of foreign material. The product was distributed in Texas.

    Product
    Texas Wild UPC, 26/30 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, Texas 77550
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-898-2013·2013-08-28

    Stayma Recalls Duet DHA 430 Vitamins for Subpotent Beta Carotene

    Stayma Consulting Service is recalling Duet DHA 430 vitamin and Omega-3 products because the beta carotene (Vitamin A) content is subpotent.

    Product
    Duet DHA 430, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE --- NDC 76331-808-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1820-2013·2013-08-28

    Plum Organics Mighty 4 Nutrition Blend Recalled for Seal Defects

    Plum Inc. is recalling Mighty 4 Essential nutrition blend pouches due to intermittent ineffective hermetic seals that may allow spoilage.

    Product
    Plum Organics Mighty 4 Essential nutrition blend; Spinach, Kiwi, Barley, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003447; Case UPC: 00846675003560 Distributed by Plum Inc., Emeryville, CA.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1841-2013·2013-08-28

    Galveston Shrimp Company Recalls Shrimp Due to Foreign Material

    Galveston Shrimp Company is recalling specific lots of frozen shrimp in Texas due to the presence of foreign material.

    Product
    Texas Wild UPC, 16/20 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-894-2013·2013-08-28

    Duet DHA Balanced Recalled for Subpotent Beta Carotene Content

    Stayma Consulting Service is recalling Duet DHA Balanced tablets and softgels because the beta carotene (Vitamin A) content is subpotent.

    Product
    Duet DHA Balanced, 1) 30 count tablet blister cards and 5 count softgels blister cards combination pack (NDC 44118-775-30 and NDC 44118-800-30) 2) physician samples (carton contain 7 envelopes each with one 5 count tablet blister card and 5 softgels (NDC 44118-800-05) Rx only…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1987-2013·2013-08-28

    Atrium Medical Recalls PleuraGuide Chest Tube Kits Due to Missing Instructions

    Atrium Medical Corporation is recalling 6,516 PleuraGuide Disposable Chest Tube Kits because individual component instructions for use are missing.

    Product
    PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1819-2013·2013-08-28

    Plum Organics Mighty 4 Nutrition Blend Recalled for Packaging Seal Defects

    Plum Inc. is recalling Mighty 4 Essential nutrition blend pouches due to intermittent ineffective hermetic seals that may allow spoilage.

    Product
    Plum Organics Mighty 4 Essential nutrition blend; Kale, Strawberry, Amaranth, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003409; Case USPC: 00846675003522 Distributed by Plum Inc., Emery ville, CA.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1837-2013·2013-08-28

    Galveston Shrimp Company Recalls Shrimp Due to Foreign Material

    Galveston Shrimp Company is recalling specific lots of wild-caught shrimp due to the presence of foreign material. The product was distributed in Texas.

    Product
    Texas Wild UPC 41/50 BSO, Shrimp Headless Shell-on, IQF Wild Caught, Product of the USA 20# Net Weight, Galveston Shrimp Co., Galveston, Texas 77550
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1835-2013·2013-08-28

    Grove Grow Notes Dried Mushrooms Recalled for Undeclared Sulfites

    S & M International Inc is recalling Grove Grow Notes Dried Mushrooms due to undeclared sulfites. The product was distributed in New York.

    Product
    Grove Grow Notes Dried Mushroom, Net Wt. 200g/7 oz. packaged in plastic tray in plastic bag. UPC 6949682800734 Product of China Product label is in Chinese
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1996-2013·2013-08-28

    Smith & Nephew Recalls Genesis II Knee Trial Inserts Due to Color Error

    Smith & Nephew is recalling nine Genesis II Cruciate Retaining Articular Insert trial units because they were produced with the wrong color material.

    Product
    GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-916-2013·2013-08-28

    Medicis Recalls CLENZIderm Pore Therapy Due to CLENZIderm Cleanser Mislabeling

    Medicis Pharmaceutical Corp is recalling CLENZIderm M.D. Pore Therapy kits because some bottles were incorrectly filled with Daily Foam Cleanser. The recall covers specific lots distributed in the US and internationally.

    Product
    CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Daily Care Foaming Cleanser (Salicylic Acid 2%) NDC 62032-111; Pore Therapy (Salicylic Acid 2%) NDC 62032-110 and Therapeutic Lotion (Benzoyl…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-893-2013·2013-08-21

    REEVA Antibacterial Hand Soap Recalled for Bacterial Contamination

    Showline Automotive Products is recalling REEVA Antibacterial Hand Soap and Dishwashing Liquid due to contamination with Sarcina Lutea bacteria.

    Product
    REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple, 0.10%, 24 fl oz. bottle, Distributed by Aldi Inc,. Batavia, IL 60510; UPC 0 4198 1525 8.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1948-2013·2013-08-21

    Ortho-Clinical Diagnostics Recalls Worn CM/RT Incubator Wear Pads

    Ortho-Clinical Diagnostics is recalling Colorimetric (CM)/ Rate (RT) incubator wear pads because they may become worn before their scheduled replacement.

    Product
    Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITROS 5,1 FS Chemistry System, 2) VITROS 5,1 FS Chemistry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1938-2013·2013-08-21

    Atrium Medical Recalls C-QUR V-Patch Mesh Due to Adhesion Issues

    Atrium Medical Corporation is recalling C-QUR V-Patch Mesh units because the coated mesh may adhere to the inner packaging liner when exposed to high humidity.

    Product
    C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1958-2013·2013-08-21

    SpineFrontier Recalls Surgical Case Lids and Bases Due to Ink Delamination

    SpineFrontier, Inc. is recalling specific surgical case lids and bases because non-toxic inks used on the graphics are delaminating or running off after repeated washing and sterilization cycles.

    Product
    Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D, 11-72014D…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-890-2013·2013-08-21

    Medi-First First Aid Kits Recalled Due to Stability Testing Failures

    Total Resources International is voluntarily recalling Medi-First 61 Piece First Aid Kits because Benzalkonium Chloride failed stability testing.

    Product
    Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Travel, Sport, Total Resources International, Walnut, CA 91789
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1975-2013·2013-08-21

    Siemens syngo.plaza Mammography Software Recall for Image Alignment Issues

    Siemens is recalling syngo.plaza software due to potential issues with mammography image laterality and alignment.

    Product
    Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1937-2013·2013-08-21

    Atrium Medical Recalls C-QUR Edge Mesh Due to Packaging Adhesion

    Atrium Medical is recalling C-QUR Edge Mesh products because the coated mesh can adhere to the inner packaging liner when exposed to high humidity.

    Product
    C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1968-2013·2013-08-21

    Terumo Advanced Perfusion System 1 Recalled for Incomplete Operator Manual Instructions

    Terumo is recalling 1,657 Advanced Perfusion System 1 units because the operator manual does not fully describe pump behavior during specific alarm conditions.

    Product
    Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-889-2013·2013-08-21

    3M Tekk First Aid Kits Recalled for Stability Testing Failures

    Total Resources Int'l is voluntarily recalling 3M Tekk Industrial/Construction First Aid Kits due to stability testing failures of Benzalkonium Chloride.

    Product
    3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Walnut, CA 91789
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1977-2013·2013-08-21

    Terumo Advanced Perfusion System 1 Recalled for False Pressure Alarm

    Terumo is recalling 1,657 Advanced Perfusion System 1 units because a false high-pressure alarm can stop the pump. The company is updating manuals and issuing labeling addenda.

    Product
    100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1934-2013·2013-08-21

    Medtronic Xomed Recalls ENT Surgical Instrument Trays for Labeling Defects

    Medtronic Xomed is recalling 3,562 ENT surgical instrument trays to replace them with units featuring improved 'PREVACUUM ONLY' labeling.

    Product
    Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide