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.

15501–15525 of 21645

  • ModerateFDA (Devices)·Z-0512-2016·2015-12-30

    Ameditech ImmuTest Cup 7-panel Drug Test Recall for Reduced Reactivity

    Ameditech is recalling ImmuTest Cup 7-panel drug tests because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0466-2016·2015-12-30

    Synvasive Oscillating Saw Blades Recalled for Incorrect Cutting Width Labeling

    Synvasive Technology Inc is recalling 14 oscillating saw blades that incorrectly identify the cutting width as 25mm instead of 19mm.

    Product
    Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No. 19075127YT1; Lot No. 45104 and 43054 Description: STRYK_76542K_19X75X1.27T General and Plastic Surgery: The oscillating surgical saw blade is intended for use with…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0454-2016·2015-12-30

    DePuy Spine Recalls Aegis Torque Handles Due to Assembly Defect

    DePuy Spine is recalling 16 Aegis Torque Handles because a manufacturing error may prevent them from fully assembling with the tightener shaft.

    Product
    Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0525-2016·2015-12-30

    Perrigo Recalls Equaline All Day Allergy Tablets Due to Impurity

    Perrigo is recalling Equaline All Day Allergy tablets because they contain an impurity called cetirizine monosaccharide ester.

    Product
    EQUALINE ALL DAY ALLERGY — EQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0267-2016·2015-12-23

    H E B Recalls Basil Pesto for Pesticide Residue

    H E B is recalling 225 units of HCC Basil Pesto in Texas due to violative pesticide residue.

    Product
    HCC Basil Pesto FS and S; Houston Culinary Center Basil Pesto
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0435-2016·2015-12-23

    Summit Medical Recalls AbsorbENT Nasal Packs Due to Missing Split

    Summit Medical is recalling specific lots of AbsorbENT nasal packs because the product lacks a required split in the packing.

    Product
    AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0269-2016·2015-12-23

    H E B Recalls Greek Pasta Salad Due to Pesticide Residue

    H E B is recalling Greek Pasta Salad products in Texas because they contain an ingredient with violative pesticide residue.

    Product
    HCC Greek Pasta Salad Small SS and FS
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0271-2016·2015-12-23

    HEB Shrimp Salad Recalled for Pesticide Residue

    H E B is recalling specific lots of HEB Shrimp Salad in Texas due to violative pesticide residue.

    Product
    HEB Shrimp Salad SS and FS By Lb; HEB Shrimp Salad 8 oz
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0418-2016·2015-12-23

    Fujifilm Medical Systems Recalls Duodenoscopes for Reprocessing Design Changes

    Fujifilm Medical Systems is recalling specific duodenoscope models as a precautionary measure because the devices have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.

    Product
    Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0405-2016·2015-12-23

    Philips Brilliance 64 CT System Software Error Recall

    Philips is recalling seven Brilliance 64 CT systems because software may set the scan length differently than planned.

    Product
    Philips Healthcare Brilliance 64 Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0432-2016·2015-12-23

    Beckman Coulter Recalls DxH 800 and 600 Hematology Analyzer Software

    Beckman Coulter is recalling specific software versions for its DxH 800 and DxH 600 hematology analyzers because the software allows the creation of multiple orders with the same specimen ID but different patient IDs.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0433-2016·2015-12-23

    Beckman Coulter Recalls DxH 800 and DxH 600 Software Versions

    Beckman Coulter is recalling specific software versions for its DxH 800 and DxH 600 hematology analyzers because the systems allow multiple orders to share the same specimen ID with different patient IDs.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0283-2016·2015-12-23

    H E B Recalls Shrimp Salad Kits Due to Pesticide Residue

    H E B is recalling 208 units of Houston Culinary Center Shrimp Salad Kits sold in Texas because of violative pesticide residue.

    Product
    Houston Culinary Center Shrimp Salad Kit
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0268-2016·2015-12-23

    HEB Sandwich Tuna Salad Recalled for Pesticide Residue

    H E B is recalling 80 units of HEB Sandwich Tuna Salad 12 Grain in Texas due to violative pesticide residue.

    Product
    HEB Sandwich Tuna Salad 12 Grain
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0280-2016·2015-12-23

    H E B Recalls Yellowfin Tuna Salad Kits for Pesticide Residue

    H E B is recalling 157 units of Houston Culinary Center Yellowfin Tuna Salad Kits sold in Texas due to violative pesticide residue.

    Product
    Houston Culinary Center Yellowfin Tuna Salad Kit
    Category
    Food
    Distribution
    1 state