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.

10901–10925 of 21617

  • ModerateFDA (Devices)·Z-1140-2018·2018-03-28

    BD Vacutainer Tubes Recalled for Lead Test Inaccuracy

    Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead levels in blood samples when used with certain assays.

    Product
    BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-1078-2018·2018-03-28

    Centurion Medical Products Recalls Skin Staple Remover Convenience Kits

    Centurion Medical Products is recalling Skin Staple Remover Convenience Kits because the included PVP Prep Pad does not meet required iodine levels for its stated shelf life.

    Product
    SKIN STAPLE REMOVER
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0932-2018·2018-03-28

    IKEA Recalls Marshmallow Candy Due to Possible Pest Contamination

    IKEA is recalling Godis Paskkyckling Marshmallow Candy due to possible pest contamination at the production facility.

    Product
    Pink flexible, plastic package: Godis Paskkyckling Marshmallow Candy; IKEA; Net Wt. 3.5 oz.; date codes: 10/23/2018 - 01/26/2019; Produced in Sweden for: by IKEA Food Services AB, Almhultsgatan 2, SE-125 86 Malmo, Sweden. Best Before: 10/23/2018 thru 01/26/2019.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1159-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Clinical Guidance Documents

    Arrow International is recalling 18,124 central venous catheterization kits because they are missing the Central Venous Catheter Placement Procedures Note and Central Line Insertion Checklist.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1167-2018·2018-03-28

    Implant Direct Recalls Swish Tapered Implants Due to Packaging Error

    Implant Direct Sybron Manufacturing is recalling 1,117 Swish Tapered Implants because the packaged extender may be positioned upside down in the plastic retainer.

    Product
    SwishTapered Implant Intended for use in support for fixed bridgework.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1158-2018·2018-03-28

    Arrow International Recalls Percutaneous Sheath Introducer Kits Missing Safety Checklists

    Arrow International is recalling 18,124 percutaneous sheath introducer kits because they lack required central line insertion checklists and procedure notes.

    Product
    Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1164-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Clinical Documentation

    Arrow International is recalling 18,124 central venous catheter kits because they lack required clinical guidance documents. The recall is nationwide.

    Product
    Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1128-2018·2018-03-28

    United Orthopedic Recalls U2 Total Knee System Tibial Inserts Due to Labeling Mismatch

    United Orthopedic Corporation is recalling 69 U2 Total Knee System Tibial Inserts because the package contents did not match the product labeling.

    Product
    U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1166-2018·2018-03-28

    Arrow International Recalls Central Venous Catheter Kits Missing Safety Checklists

    Arrow International is recalling 18,124 central venous catheter kits because they lack required safety checklists and procedure notes.

    Product
    ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1152-2018·2018-03-28

    Arrow International Recalls ARROWg+ard Blue PLUS Catheters Due to Missing Lid Information

    Arrow International Inc is recalling 420 ARROWg+ard Blue PLUS catheters because certain lots may be missing lot numbers, expiration dates, and UDI information on the lid.

    Product
    ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against cat
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1163-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Safety Checklists

    Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required procedural notes and insertion checklists.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access to central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1079-2018·2018-03-28

    Centurion Medical Recalls Suture Removal Kits with Low Iodine Prep Pads

    Centurion Medical Products is recalling suture removal kits because the included PVP prep pads do not meet required iodine levels for their 36-month shelf life.

    Product
    SUTURE REMOVAL TRAY, SET or KIT
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1077-2018·2018-03-28

    Epigenomics Recalls Epi proColon Plasma Quick Kit Due to Invalid Test Runs

    Epigenomics Ag is recalling 200 units of the Epi proColon Plasma Quick Kit because the diagnostic test may produce invalid runs, potentially delaying results.

    Product
    Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1131-2018·2018-03-28

    CooperSurgical 2 MHz Waterproof OB Probe Recalled for Mislabeling

    CooperSurgical is recalling 13 units of 2 MHz Waterproof OB probes because they were incorrectly labeled as 3 MHz probes.

    Product
    Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determinin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1147-2018·2018-03-28

    Ethicon Recalls DERMABOND PRINEO Skin Closure System Lots

    Ethicon is recalling specific lots of the DERMABOND PRINEO Skin Closure System because the adhesive may not dry within the specified time and may fall off.

    Product
    DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0607-2018·2018-03-28

    Pine Pharmaceuticals Recalls Brilliant Blue G Intraocular Injection Due to Labeling Error

    Pine Pharmaceuticals is recalling 136 units of Brilliant Blue G for Intraocular Injection because the vial label contains incorrect active and inactive ingredient information.

    Product
    Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1080-2018·2018-03-28

    Centurion Medical Products Recalls General Purpose Instrument Trays

    Centurion Medical Products is recalling General Purpose Instrument Trays because a PVP Prep Pad in the kit does not meet required iodine levels for shelf life.

    Product
    GENERAL PURPOSE INSTRUMENT TRAY
    Category
    Medical Device
    Distribution
    0 states