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.

15851–15875 of 21645

  • ModerateFDA (Devices)·Z-2471-2015·2015-09-02

    Baxter Recalls MiniCap Peritoneal Dialysis Transfer Sets for Labeling Updates

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets to update labeling with new safety instructions and warnings.

    Product
    MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2476-2015·2015-09-02

    AMUSA Recalls 0.9% Sodium Chloride Injection Due to Process Control Issues

    MRP, LLC dba AMUSA is recalling 0.9% Sodium Chloride Injection because procedures for product acceptance and control were not adequately established.

    Product
    0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-1369-2015·2015-09-02

    Mucinex Fast-Max DM Max Recalled for Missing Drug Facts Labeling

    Reckitt Benckiser is recalling Mucinex Fast-Max DM Max bottles because the back label is missing active ingredients and safety warnings.

    Product
    MUCINEX FAST-MAX DM MAX AND MUCINEX NIGHTTIME COLD AND FLU — MUCINEX FAST-MAX DM MAX AND MUCINEX NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·115-2015·2015-08-27

    Swanson Recalls Boneless Beef Tender Tips Due to Undeclared Allergens

    Swanson Meats is recalling approximately 20,063 pounds of boneless beef tender tips because the labels failed to declare soybean oil, MSG, and papain.

    Product
    Swanson Meat Co. — Recall Notification Report 115-2015 (Boneless Beef Tender Tips)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2388-2015·2015-08-26

    C.R. Bard Recalls Magic3 Female Intermittent Urinary Catheters for Sterile Breach

    C.R. Bard is recalling 534,972 Magic3 Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2343-2015·2015-08-26

    Draeger Evita Infinity V500 Ventilator Battery Recall

    Draeger Medical is recalling 2,081 Evita Infinity V500 ventilators because the optional PS500 battery capacity did not last as long as expected.

    Product
    PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2428-2015·2015-08-26

    Stryker Recalls Radio-Capitellum Implants Due to Packaging Integrity Concerns

    Stryker Howmedica Osteonics Corp. is recalling specific Radio-Capitellum implants because transportation may have compromised the sterile barrier of the packaging.

    Product
    Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1347-2015·2015-08-26

    Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigations

    Wockhardt USA LLC is recalling 3,378 bottles of Lisinopril 20 mg tablets because an FDA inspection found inadequate investigations of past market complaints.

    Product
    Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 94106 5, NDC 64679-941-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2406-2015·2015-08-26

    Veridex Recalls Cell Search Circulating Tumor Kits Due to Artifacts

    Veridex, LLC is recalling 1,560 Cell Search Circulating Tumor Kits due to the presence of artifacts and control failures.

    Product
    Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2970-2015·2015-08-26

    HEB Wheat Buns Recalled for Potential Cotton Fiber Contamination

    H E B Grocery Company is recalling specific wheat buns that may contain cotton fibers. Consumers in Texas should check their pantries.

    Product
    Good Bread 16 Wheat Buns, Net Wt. 29.4 oz (832g); HEB Bake Shop 8 Wheat Hamburger Buns, Net Wt. 18 OZ (1 LB 2 OZ), UPC: 041220191642
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2404-2015·2015-08-26

    Siemens Artis zee/zeego Systems Recalled for X-ray Locking Function Defect

    Siemens Medical Solutions is recalling 586 Artis zee/zeego angiography systems because a system error could prevent users from exiting the X-ray locking function without a restart.

    Product
    Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2396-2015·2015-08-26

    Winco Drop Arm Care Cliner Chairs Recalled for Fire Retardant Mislabeling

    Winco Mfg., LLC is recalling Drop Arm Care Cliner chairs because the foam was mislabeled as fire retardant but is actually standard foam.

    Product
    Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2385-2015·2015-08-26

    C.R. Bard Recalls Magic3 Intermittent Urinary Catheters Due to Sterile Breach

    C.R. Bard is recalling 91,140 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2384-2015·2015-08-26

    C.R. Bard Recalls Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters

    C.R. Bard is recalling 14,310 units of Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2389-2015·2015-08-26

    Stryker Triathlon X3 Tibial Bearing Insert Recall Due to Labeling Error

    Stryker is recalling 10 units of Triathlon X3 Tibial Bearing Inserts because one unit was found in a pack labeled for a different model.

    Product
    Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2420-2015·2015-08-26

    Medtronic EOPA Arterial Cannula Recalled for Missing Guidewire

    Medtronic is recalling EOPA Arterial Cannulas (Lot 2015060544) because they were shipped without the required guidewire.

    Product
    Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2974-2015·2015-08-26

    HEB Wheat Hot Dog Buns Recalled for Potential Cotton Fiber Contamination

    H E B Grocery Company is recalling HEB Bake Shop 8 Wheat Hot Dog Buns because they may contain cotton fibers. The recall covers 1,727 units distributed in Texas.

    Product
    HEB Bake Shop 8 Wheat Hot Dog Buns, Net Wt. 12 OZ, UPC: 041220191659
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2971-2015·2015-08-26

    HEB Bake Shop Whole Wheat Hamburger Buns Recalled for Cotton Fibers

    H E B Grocery Company is recalling 653 units of HEB Bake Shop 100% Whole Wheat Hamburger Buns because they may contain cotton fibers.

    Product
    HEB Bake Shop 100% Whole Wheat 8 Hamburger Buns, Net Wt. 17.75 OZ (1 LB 1.75 OZ), UPC: 041220830565
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2422-2015·2015-08-26

    International Biophysics Recalls IBC Suction Wands Due to Seal Defects

    International Biophysics Corp. is recalling 100 IBC Suction Wands because heat seals on sterile pouches may not meet strength criteria.

    Product
    IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2968-2015·2015-08-26

    HEB Bake Shop Hamburger Buns Recalled for Potential Cotton Fiber Contamination

    H E B Grocery Company, LP is recalling specific HEB Bake Shop hamburger buns because they may contain cotton fibers. The recall covers 4,540 units distributed in Texas.

    Product
    HEB Bake Shop 8 Hamburger, Enriched Buns, Net Wt. 17.75 OZ (1 LB 1.75 OZ), UPC: 04122041461; HEB Bake Shop 6 Texas Sized Hamburger Buns Enriched Buns, Net Wt. 17.75 OZ (1 LB 1.75 OZ), UPC: 041220742264; Kurz Texas Size Plain Buns (no label)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2973-2015·2015-08-26

    H E B Recalls Good Bread Hot Dog Buns for Cotton Fiber Contamination

    H E B Grocery Company is recalling specific Good Bread hot dog buns because they may contain cotton fibers. The affected products were distributed in Texas.

    Product
    Good Bread 10" Coney, Net Wt. 18.2 OZ (516g), UPC: 041220181506; Good Bread 16 Hot Dog Enriched Buns Net Wt. 24 oz (680g) UPC: 04122018147
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2421-2015·2015-08-26

    Trilliant Surgical Recalls Non-Sterile Cannulated Screw Countersinks

    Trilliant Surgical Ltd. is recalling 102 units of non-sterile cannulated screw countersinks because their cutting efficiency was out of specification.

    Product
    2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis…
    Category
    Medical Device
    Distribution
    Distributed nationwide