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.

15451–15475 of 21645

  • ModerateFDA (Devices)·Z-0554-2016·2016-01-06

    Merge Hemo Software Recalled Due to Incomplete Validation

    Merge Healthcare is recalling Merge Hemo software version 10.0 LA because it was distributed to three customers before being fully validated in-house.

    Product
    Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0565-2016·2016-01-06

    RenovoCath RC 120 Catheter Recalled for Incorrect Instructions for Use

    RenovoRx, Inc. is recalling 11 units of the RenovoCath RC 120 Temporary Intravascular Occluding Catheter because incorrect Instructions for Use were shipped to customers.

    Product
    RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: The RenovoCath RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateUSDA FSIS·001-2016·2016-01-04

    Huisken Meat Company Recalls Beef Patties Due to Wood Contamination

    Huisken Meat Company is recalling Sams Choice Black Angus Beef Patties with Vidalia Onion due to possible wood contamination. No illnesses have been reported.

    Product
    Branding Iron Holdings — Huisken Meat Company Recalls Beef Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0545-2016·2015-12-30

    Philips Brilliance iCT CT System Recalled for Perfusion Software Issue

    Philips is recalling 51 Brilliance iCT CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Brilliance iCT Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0550-2016·2015-12-30

    Siemens Syngo Imaging XS PACS Recall for Incorrect Print Sizes

    Siemens is recalling 42 units of Syngo Imaging XS software because printouts may be in incorrect anatomical size when using unsupported printers.

    Product
    Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0508-2016·2015-12-30

    Ameditech Immutest 11 Pnl Drug Screen Cup Recall for Reduced Reactivity

    Ameditech is recalling Immutest 11 Pnl Drug Screen Cups because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0439-2016·2015-12-30

    Biomerieux Recalls Etest Piperacillin/Tazobactam Tests Due to False Results

    Biomerieux is recalling Etest Piperacillin/Tazobactam tests because they may report false susceptible results for bacteria.

    Product
    Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0491-2016·2015-12-30

    Ameditech CLIA RDTC 12-Panel Cup Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling 10,320 CLIA RDTC 12-Panel Cup kits nationwide because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0462-2016·2015-12-30

    Boston Scientific Recalls IntellaTip MiFi XP Catheters Due to Tip Bends

    Boston Scientific is recalling IntellaTip MiFi XP catheters because the rate of distal tip bends and kinks exceeded anticipated levels during routine monitoring.

    Product
    IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0449-2016·2015-12-30

    Zimmer NexGen Knee Implant Recalled for Missing Inner Package Seal

    Zimmer Manufacturing B.V. is recalling 179 NexGen System tibial components due to missing Tyvek seals on inner packaging, reported from Thailand.

    Product
    Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0464-2016·2015-12-30

    Boston Scientific Recalls IntellaTip MiFi XP Catheters Due to Tip Bends

    Boston Scientific is recalling IntellaTip MiFi XP catheters because the rate of distal tip bends and kinks exceeded anticipated levels during routine monitoring.

    Product
    IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40; Catalog number: PM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0473-2016·2015-12-30

    Becton Dickinson Recalls Vancomycin Screen Agar Due to Growth Issues

    Becton Dickinson is recalling specific lots of Vancomycin Screen Agar because expired and in-date products may show breakthrough growth of vancomycin-susceptible Enterococcus faecalis near the end of shelf life.

    Product
    Vancomycin Screen Agar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0547-2016·2015-12-30

    Philips Ingenuity Core CT System Recalled for Perfusion Software Access Issue

    Philips Medical Systems is recalling 135 Ingenuity Core CT systems because a software upgrade may have restricted access to the basic axial perfusion feature for some users.

    Product
    Ingenuity Core Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0465-2016·2015-12-30

    Boston Scientific Recalls IntellaTip MiFi XP Catheters Due to Tip Bends

    Boston Scientific is recalling IntellaTip MiFi XP catheters because the rate of distal tip bends and kinks exceeded anticipated levels during routine monitoring.

    Product
    IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog number: PM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0480-2016·2015-12-30

    Synaptive Medical BrightMatter Navigator System Recalled for RF Emission Exceedance

    Synaptive Medical is recalling eight BrightMatter Navigator Systems because they exceeded radio frequency emission limits. The devices were distributed to facilities in five US states.

    Product
    Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0498-2016·2015-12-30

    Ameditech DrugSmart Cup Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling DrugSmart Cup drug tests because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D
    Category
    Medical Device
    Distribution
    Distributed nationwide