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.

13651–13675 of 21617

  • ModerateFDA (Devices)·Z-0321-2017·2016-11-09

    Mindray TD60 Display Telemetry Transmitter Recalled for Bezel Cracking and Power Issues

    Mindray is recalling 1,278 TD60 Display Telemetry Transmitters because the bezel may crack or the device may fail to power on.

    Product
    TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0331-2017·2016-11-09

    Arrow Hands-Off Infusion Port Thermodilution Catheter Recalled for Labeling Inconsistency

    Arrow International Inc is recalling specific lots of Hands-Off Infusion Port Thermodilution Catheters due to a labeling inconsistency. The recall covers 330 units in the US and 1,031 units outside the US.

    Product
    HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practitioner to prepare, test, and insert the catheter without…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0343-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Softip XF Guide Catheters

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0338-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Softip XF Guide Catheters

    Stryker Neurovascular is recalling 1,478 Guider Softip XF Guide Catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40DEG XF/6FR/90CM, Model number: H965100420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0120-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess 1/20 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess 1/20 tablets because they contain subpotent levels of ethinyl estradiol. The recall covers 393,981 tablets distributed nationwide and in Puerto Rico.

    Product
    Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0123-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess 24 FE 1.5/30 Oral Contraceptives

    Par Pharmaceutical is recalling Gildess 24 FE 1.5/30 oral contraceptives because the ethinyl estradiol component is subpotent. The recall covers 44,127 tablets distributed nationwide and in Puerto Rico.

    Product
    Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0377-2017·2016-11-09

    Rikki USA Recalls Sallere Hollandaise Sauce Due to Mold Presence

    Rikki USA, Inc. is recalling Sallere Classic Sauces and Butters Hollandaise Sauce because of mold. The product was distributed in Maryland and Oregon.

    Product
    Hollandaise Sauce, sold as Sallere Classic Sauces and Butters, refrigerated product. Each plastic tub has a net wt 7 oz. The label is read in parts: "***HOLLANDAISE SAUSE***Use on chicken, seafood and vegetables***.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0117-2017·2016-11-09

    Taro Recalls Desoximetasone Cream Due to Stability Test Failures

    Taro Pharmaceuticals is recalling specific lots of Desoximetasone Cream 0.05% because they failed stability specifications for homogeneity.

    Product
    DESOXIMETASONE — DESOXIMETASONE (DESOXIMETASONE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0327-2017·2016-11-09

    B. Braun Recalls Spinal Anesthesia Trays with Lidocaine Component

    B. Braun Medical is voluntarily recalling specific lots of Custom Spinal Anesthesia Trays because the lidocaine component does not meet color specifications.

    Product
    Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional anesthesia
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0335-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters for Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF Guide Catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0345-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER STRAIGHT XF 5F 90CM, Model number: . M003100640. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0334-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/MP XF/8FR/100 cm, Model number: M003101480. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateUSDA FSIS·103-2016·2016-11-06

    OSI Industries Recalls Chicken Patties Due to Foreign Matter

    OSI Industries is recalling approximately 21,403 pounds of frozen chicken patties that may contain blue plastic fragments.

    Product
    OSI Industries, LLC — OSI Industries, LLC Recalls Chicken Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0302-2017·2016-11-02

    TEM Systems Recalls ex-TEM Assay Reagents Due to Low Vial Levels

    TEM Systems Inc is recalling ex-TEM Assay reagents for the ROTEM delta system because customers reported low or empty vials.

    Product
    ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0261-2017·2016-11-02

    Pharmatech Recalls Polyvitamin Liquid with Iron Due to Potential Contamination

    Pharmatech LLC is recalling 201,784 bottles of Polyvitamin Liquid with Iron as a precautionary measure due to potential contamination with Burkholderia cepacia.

    Product
    Polyvitamin Liquid with Iron, 50 mL, OTC Non-Sterile. Dietary supplement.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-0259-2017·2016-11-02

    Pharmatech Recalls Ferrous Sulfate Liquid Due to Potential Contamination

    Pharmatech LLC is recalling 75,972 bottles of Ferrous Sulfate Liquid as a precautionary measure due to potential contamination with Burkholderia cepacia.

    Product
    Ferrous Sulfate Liquid, 16 oz./473 mL, OTC Non-Sterile. Dietary supplement.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0320-2017·2016-11-02

    Siemens CMV IgM Assay Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 CMV IgM Assay kits due to reported increased imprecision and high coefficient of variation results.

    Product
    IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985725 (US); and REF/Catalog Number L2KCM2 - 200 tests (OUS), SMN 10371320 (OUS), UDI 00630414961163 (OUS); IVD --- Siemens Healthcare…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0318-2017·2016-11-02

    Pentax Video Gastroscope Recall for Updated Operation and Reprocessing Instructions

    Pentax of America Inc is recalling video gastroscopes to provide customers with the most recent Operation and Reprocessing Instructions (IFUs).

    Product
    Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0254-2017·2016-11-02

    Pharmatech LLC Recalls Virtrate-2 Dietary Supplement Due to Contamination Risk

    Pharmatech LLC is recalling 34,612 bottles of Virtrate-2 dietary supplement due to a potential risk of contamination with Burkholderia cepacia.

    Product
    Virtrate-2, Sodium Citrate-Citric Acid, 16oz./473 mL, OTC Non-Sterile. Dietary supplement.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-0268-2017·2016-11-02

    Pharmatech Recalls D-Vita Drops Due to Potential B. cepacia Contamination

    Pharmatech LLC is recalling 90,504 bottles of D-Vita Drops dietary supplements due to a precautionary measure regarding potential contamination with Burkholderia cepacia.

    Product
    D-Vita Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
    Category
    Food
    Distribution
    4 states