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.

10626–10650 of 21617

  • ModerateFDA (Devices)·Z-1757-2018·2018-05-16

    Tornier Aequalis Humeral Nail Drill Bit Recall for Packaging Defect

    Tornier is recalling Aequalis Humeral Nail Drill Bits because the tips may puncture sterile packaging, potentially compromising sterility.

    Product
    AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1653-2018·2018-05-16

    Siemens Creatine Kinase MB Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling the Dimension Creatine Kinase MB (MBI) assay because it may produce inaccurate results when used with certain drugs.

    Product
    Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1778-2018·2018-05-16

    Siemens Syngo.Via Software Recall for Report Functionality Defect

    Siemens Medical Solutions is recalling Syngo.Via VB20A software because corrected report values are not saved or transmitted, causing the system to use original values.

    Product
    Syngo.Via VB20A model 1049610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1771-2018·2018-05-16

    Bard Peripheral Vascular Recalls POWERPORT ClearVUE Implantable Ports

    Bard Peripheral Vascular Inc is recalling 181 POWERPORT ClearVUE Slim catheters because the included Patient ID Card has incorrect flushing instructions.

    Product
    POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0771-2018·2018-05-16

    Kroger Specialty Pharmacy Recalls Revlimid Capsules Due to Processing Controls

    Kroger Specialty Pharmacy is recalling Revlimid 10 mg oral capsules due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.

    Product
    Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1657-2018·2018-05-16

    Siemens Dimension Vista AST Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista AST assays because they may produce inaccurate results when measuring patients taking sulfasalazine or sulfapyridine.

    Product
    Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1769-2018·2018-05-16

    Bard POWERPORT ClearVUE Slim Catheter Recalled for Incorrect Patient Card Instructions

    Bard Peripheral Vascular Inc is recalling 835 units of POWERPORT ClearVUE Slim catheters because the included Patient ID Card contains incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1772-2018·2018-05-16

    Bard POWERPORT ClearVUE Implantable Port Recall for Incorrect Instructions

    Bard Peripheral Vascular Inc is recalling 15 units of POWERPORT ClearVUE isp Implantable Port kits because the included Patient ID Card contains incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1782-2018·2018-05-16

    Ondamed Biofeedback Device Recalled for Lack of Marketing Clearance

    Ondamed Inc is recalling 585 Ondamed Biofeedback Devices because they were marketed in the US without FDA clearance. Customers are advised to contact the firm for an available upgrade.

    Product
    Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1689-2018·2018-05-16

    Siemens ADVIA Centaur Folate Recalled for Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate assays because biotin interference levels are not listed in the instructions, potentially affecting test accuracy.

    Product
    ADVIA Centaur¿ Folate (FOL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1395-2018·2018-05-16

    Munk Pack Protein Cookie Recall Issued Due to Mold Growth

    Munk Pack Inc. is recalling specific lots of Double Dark Chocolate Protein Cookies due to mold growth. Consumers should check their pantry and discard affected products.

    Product
    Munk Pack PROTEIN COOKIE DOUBLE DARK CHOCOLATE NET WT 2.96oz (84g); UPC: 853787005368
    Category
    Food
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-1656-2018·2018-05-16

    Siemens Dimension Vista ALTI Assay Recalled for Drug Interference

    Siemens is recalling Dimension Vista ALTI assays because they may produce inaccurate results when patients take sulfasalazine or sulfapyridine.

    Product
    Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1773-2018·2018-05-16

    Bard POWERPORT ClearVUE Slim Implantable Port Recalled for Incorrect Instructions

    Bard Peripheral Vascular Inc is recalling 10 units of POWERPORT ClearVUE Slim Implantable Port kits because the included Patient ID Card contains incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1779-2018·2018-05-16

    MHC Medical Recalls EasyTouch Insulin Syringes Due to Lot Labeling Error

    MHC Medical Products LLC is recalling EasyTouch Insulin Syringes because retail cartons may display incorrect lot numbers.

    Product
    EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1765-2018·2018-05-16

    Bard POWERPORT ClearVUE Slim Catheter Recalled for Incorrect Patient ID Card Instructions

    Bard Peripheral Vascular Inc is recalling 383 units of POWERPORT ClearVUE Slim catheters because the packaged Patient ID Card contains incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0749-2018·2018-05-16

    Kroger Specialty Pharmacy Recalls Kitabis Pak Due to Processing Controls

    Kroger Specialty Pharmacy is recalling Kitabis Pak 300 mg/5 mL Soln due to a lack of processing controls. The product was distributed in five states.

    Product
    Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0777-2018·2018-05-16

    Kroger Specialty Pharmacy Recalls Ibrance Capsules Due to Processing Controls

    Kroger Specialty Pharmacy is recalling Ibrance 125 mg capsules due to a lack of processing controls. The recall covers units dispensed in five states between December 2017 and February 2018.

    Product
    Ibrance 125 mg cap NDC 00069-0189-21 28 days supply
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Food)·F-1309-2018·2018-05-09

    Target Chocolate Fudge Brownies Recalled Due to Temperature Control Issues

    Target is recalling 2,652 units of MP Premium I 48oz Chocolate Fudge Brownies sold in Hawaii because a shipping container was not held at the proper temperature.

    Product
    MP PREMIUM I 48OZ CHOC FUDG BRWN UPC: 85239735619 Target item number: 288-7-3561
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1584-2018·2018-05-09

    CooperSurgical Recalls 5 mm Apple-Hunt Secondary Cannulas Due to Packaging Error

    CooperSurgical, Inc. is recalling 520 units of 5 mm Apple-Hunt Secondary Cannulas because they were packaged with the wrong trocar length type.

    Product
    5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 Product Usage: The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic surgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1374-2018·2018-05-09

    Target Recalls Moose Tracks Denali Ice Cream Due to Temperature Issues

    Target is recalling Moose Tracks Denali Ice Cream sold in Hawaii because a shipping container was not held at the proper temperature, posing a risk of contamination.

    Product
    "Moose Tracks" denali Ice Cream 48 oz UPC: 85239007853 Target item number: 288-7-81
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1195-2018·2018-05-09

    Target Recalls Enlightened Mint Chip Swirl Ice Cream Bars in Hawaii

    Target is recalling Enlightened Mint Chip Swirl Ice Cream Bars in Hawaii because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    Enlightened Mint Chip Swirl Ice Cream Bar; UPC: 852109331321 Target item number 288-7-1789
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1220-2018·2018-05-09

    Target Recalls Hot Pockets Pizza Due to Temperature Control Issues

    Target is recalling 2-ct. Hot Pockets X Four Cheese Pizza in Hawaii because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    2-ct. (9-oz.) Hot Pockets X Four Cheese Pizza UPC: 43695071092 Target item number: 270-6-190
    Category
    Food
    Distribution
    1 state