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.

9951–9975 of 21617

  • ModerateFDA (Devices)·Z-0031-2019·2018-10-10

    Oridion Capnostream20 Bedside Monitors Recalled for Settings Reset Defect

    Oridion Medical is recalling 400 Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0034-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling 48 refurbished Capnostream20 monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0042-2019·2018-10-10

    Oridion Medical CAPNOSTREAM 20P Monitors Recalled for Settings Reset

    Oridion Medical is recalling CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0046-2019·2018-10-10

    Oridion Capnostream20 M NICU Monitors Recalled for Settings Reset

    Oridion Medical is recalling 262 Capnostream20 M NICU monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 M NICU (CPM), CS08654RN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0050-2019·2018-10-10

    Oridion Capnostream20 N Bedside Monitors Recalled for Settings Reset

    Oridion Medical is recalling Capnostream20 N bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 N CYVITAL, CS08799
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0033-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling 43 refurbished Capnostream20 monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US)M REFURBISHED, Part Number CS78653
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0001-2019·2018-10-10

    Teva Recalls Clozapine Tablets Due to Failed Disintegration Testing

    Teva Pharmaceuticals is recalling 313 bottles of Clozapine 12.5 mg tablets because routine stability testing showed the tablets failed to disintegrate as required.

    Product
    CLOZAPINE — CLOZAPINE (CLOZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0027-2019·2018-10-10

    Oridion Capnostream 20P Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling 696 Capnostream 20P patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0045-2019·2018-10-10

    Oridion Capnostream20 M Adult ICU Monitors Recalled for Settings Reset

    Oridion Medical is recalling five Capnostream20 M Adult ICU monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 M ADULT ICU (CPM), CS08654RA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0012-2019·2018-10-10

    Exactech Equinoxe Reverse Drill Bit Kit Recalled for Incorrect Components

    Exactech is recalling Equinoxe Reverse Drill Bit Kits because they may contain two 2mm drill bits instead of the intended 2mm and 3.2mm combination.

    Product
    Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0047-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling 23 Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (INTL) M W/PRINTER, CS08660
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0030-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) M TO MASIMO, Part Number CS08750
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0054-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling eight refurbished Capnostream20 monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1992-2018·2018-10-10

    Trader Darwin's Chewable Melatonin Recalled for Misbranding and Wrong Product Contents

    Church & Dwight is recalling Trader Darwin's Chewable Peppermint Flavored Melatonin because bottles contain GABA Calm Sublingual Orange tablets instead.

    Product
    Trader Darwin s Chewable Peppermint Flavored Melatonin Dietary Supplement Number of units per package: 100 tablets Package type: Bottle Units per case: 36
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0007-2019·2018-10-10

    Dr. Reddy's Recalls Nystatin and Triamcinolone Cream for Stability Failures

    Dr. Reddy's Laboratories is recalling Nystatin and Triamcinolone Acetonide Cream because stability testing showed out-of-specification results for Nystatin composition.

    Product
    Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ -
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0006-2019·2018-10-10

    Sichuan Friendly Pharmaceutical Recalls Thyroid Powder Due to CGMP Deviations

    Sichuan Friendly Pharmaceutical Co., Ltd. is recalling Thyroid Powder 25kg/drum because the product has inconsistent levels of active ingredients.

    Product
    Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298. NDC 7807-0170-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0035-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling 22 refurbished Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0061-2019·2018-10-10

    Ortho VITROS TSH Reagent Packs Recalled for Potential Biotin Interference

    Ortho Clinical Diagnostics is recalling VITROS TSH Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated in the instructions.

    Product
    VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0052-2019·2018-10-10

    Oridion Capnostream20 Bedside Patient Monitor Recall for Settings Reset

    Oridion Medical is recalling 11 refurbished Capnostream20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (INTL) M REFURBISHED, CS78654
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0053-2019·2018-10-10

    Oridion Capnostream20 Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling six refurbished Capnostream20 patient monitors because alarm and time settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0010-2019·2018-10-10

    Radiometer ABL90 FLEX Analyzers Recalled for Fluid Aspiration Error

    Radiometer America Inc. is recalling ABL90 FLEX analyzers with software version 3.3MR1 or below because they may aspirate calibration solution instead of rinse solution.

    Product
    ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near
    Category
    Medical Device
    Distribution
    0 states