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.

8151–8175 of 21595

  • ModerateFDA (Devices)·Z-2340-2019·2019-08-28

    Pro-Dex Surgical Driver Battery Packs Recalled for Visual Particulates

    Pro-Dex Inc is recalling sterile surgical driver battery packs due to visual particulates found within the Tyvek pouches.

    Product
    PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1826-2019·2019-08-28

    Medtech Recalls Clear Eyes Assorted Displays Due to Quality Control Concerns

    Medtech Products is recalling Clear Eyes Assorted IRC Displays due to concerns about quality assurance controls in the manufacturing facility.

    Product
    Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochlorid
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1823-2019·2019-08-28

    Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues

    Medtech Products is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls in the manufacturing facility.

    Product
    Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Dist. by Lil' Drug Store Products Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402; Medtech Products Inc., Tarrytown, NY 10591, UPC 7 92554
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2327-2019·2019-08-28

    BD Max ExK TNA 2 Extraction Tube Kit Recall for Sealing Defects

    Becton Dickinson is recalling BD Max ExK TNA 2 kits because foil bags containing extraction tubes may not have been sealed properly.

    Product
    Kit BD Max ExK TNA 2; Catalog # 442825
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2335-2019·2019-08-28

    BD Max GC RT PCR Assay Recalled for Improperly Sealed Foil Bags

    Becton Dickinson is recalling BD Max GC RT PCR Assay kits because foil bags containing extraction tubes may not be sealed properly.

    Product
    Kit BD Max GC RT PCR Assay; Catalog # 443486
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2342-2019·2019-08-28

    Siemens MAGNETOM Aera MRI Devices Recalled for Quench Venting System Port Issue

    Siemens Medical Solutions USA is recalling 143 MAGNETOM Aera MRI devices due to a potential open port in the quench venting system when using the optional horizontal outlet.

    Product
    MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Drugs)·D-1835-2019·2019-08-28

    Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues

    Medtech Products, Inc. is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls in the manufacturing facility.

    Product
    Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 78112 25418 7) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by M
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2323-2019·2019-08-28

    BD Max ExK DNA 1 USA Extraction Tube Sealing Defect Recall

    Becton Dickinson is recalling 115 units of BD Max ExK DNA 1 USA kits because foil bags containing extraction tubes may not be sealed properly.

    Product
    Kit BD Max ExK DNA 1 USA; Catalog # 442817
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2326-2019·2019-08-28

    BD MAX Reagent Extraction Tubes Recalled for Improper Sealing

    Becton Dickinson is recalling BD MAX Reagent extraction tubes because foil bags may not be sealed properly, potentially compromising product integrity.

    Product
    Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Drugs)·D-1829-2019·2019-08-28

    Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues

    Medtech Products is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls in the manufacturing facility.

    Product
    Clear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10552 6) of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (individual bottle UPC 6 78112 25415 6); Distributed by Me
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2347-2019·2019-08-28

    Aniara Diagnostica Recalls ZYMUTEST HIA MonoStrip ELISA Kits

    Aniara Diagnostica LLC is recalling 46 units of ZYMUTEST HIA MonoStrip ELISA kits due to residual crystallization and out-of-range negative controls.

    Product
    ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1824-2019·2019-08-28

    Medtech Recalls Clear Eyes Maximum Itchy Eye Relief Drops

    Medtech Products is recalling Clear Eyes Maximum Itchy Eye Relief drops due to quality assurance concerns at the manufacturing facility.

    Product
    Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 65920 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2330-2019·2019-08-28

    BD MAX Enteric Bacterial Panel Extraction Tube Sealing Defect Recall

    Becton Dickinson is recalling BD MAX Enteric Bacterial Panel kits because foil bags containing extraction tubes may not have been sealed properly.

    Product
    Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2329-2019·2019-08-28

    BD Max Enteric Parasite Panel EU Extraction Tube Sealing Defect

    Becton Dickinson is recalling BD Max Enteric Parasite Panel EU kits because foil bags containing extraction tubes may not be sealed properly.

    Product
    Kit BD Max Enteric Parasite Panel EU; Catalog # 442960
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2351-2019·2019-08-28

    Siemens ACUSON NX2 Ultrasound Systems Recalled for Acoustic Output Defect

    Siemens is recalling 70 ACUSON NX2 ultrasound systems because internal testing found transducers may exceed defined acoustic output power values.

    Product
    ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2328-2019·2019-08-28

    BD MAX MRSA Reagent Kit Recall Due to Improperly Sealed Foil Bags

    Becton Dickinson is recalling 176 units of BD MAX MRSA Reagent Kits because foil bags containing extraction tubes may not have been sealed properly.

    Product
    Kit BD Max MRSA; Catalog # 442953
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2339-2019·2019-08-28

    BD Max Enteric Viral Panel EU Extraction Tube Sealing Defect

    Becton Dickinson is recalling BD Max Enteric Viral Panel EU kits because foil bags containing extraction tubes may not have been sealed properly.

    Product
    Kit BD Max Enteric Viral Panel EU Catalog # 443985
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2346-2019·2019-08-28

    Aniara ZYMUTEST HIA MonoStrip IgG ELISA kit recalled for quality issues

    Aniara Diagnostica LLC is recalling 51 units of the ZYMUTEST HIA MonoStrip IgG ELISA kit due to residual crystallization and out-of-range negative controls.

    Product
    ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2357-2019·2019-08-28

    Cambridge Sensors Recalls Microdot Xtra Blood Glucose Test Strips

    Cambridge Sensors Limited is recalling Microdot Xtra blood glucose test strips in Illinois because faulty manufacturing equipment prevented the strips from fitting into the meter.

    Product
    Microdot Xtra blood glucose test strips
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2325-2019·2019-08-28

    BD Max ExK DNA 2 USA Extraction Tube Sealing Defect Recall

    Becton Dickinson is recalling BD Max ExK DNA 2 USA kits because foil bags containing extraction tubes may not have been sealed properly.

    Product
    Kit BD Max ExK DNA 2 USA; Catalog # 442819
    Category
    Medical Device
    Distribution
    38 states