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.

20376–20400 of 21633

  • ModerateFDA (Devices)·Z-1407-2013·2013-06-05

    Alpine Biomed Recalls Natus Dantec KEYPOINT.NET Software Due to Bug

    Alpine Biomed Aps is recalling Natus neurology Dantec KEYPOINT.NET version 2.20 software due to a software bug. The recall affects 871 installed licenses distributed worldwide.

    Product
    Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA, 9033A071101, 9031A070101, 9031A006401, 9031A006501, 9033A004701, 9031A0032…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1377-2013·2013-06-05

    Anspach Effort 3mm Diamond Ball Burrs Recalled for Grit Size Defect

    The Anspach Effort, Inc. is recalling 1,827 3mm Diamond Ball burrs because three batches may have diamond grit larger than intended.

    Product
    ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1396-2013·2013-06-05

    Stryker Orthobiologics Aliquot Reamer Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 7 units of the Aliquot Reamer, 6" (Part Number 2110-0504) because the catheter may break during removal from the needle.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1411-2013·2013-06-05

    Spinal Solutions Recalls Set Screws Due to Missing Surgical Instructions

    Spinal Solutions is recalling 106 Set Screws (Item #BG3010) because directions for use and surgical techniques were not provided to every physician.

    Product
    Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1423-2013·2013-06-05

    Becton Dickinson Recalls BBL DrySlide Oxidase Kits Due to Packaging Error

    Becton Dickinson is recalling BBL DrySlide Oxidase Kits because they were placed in incorrect packaging for distribution to laboratories.

    Product
    BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1390-2013·2013-06-05

    Stryker Orthobiologics Aliquot Delivery System Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 155 units of the Aliquot Syringe Delivery System because the catheter may break during removal from the needle.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1400-2013·2013-06-05

    Beckman Coulter Recalls Lactate Reagent Due to Error Messages

    Beckman Coulter is recalling Lactate Reagent Lot M206209 because it may fail to report numerical values for high lactate concentrations.

    Product
    Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1428-2013·2013-06-05

    Intuitive Surgical Recalls da Vinci Flush Ports for Labeling Clarification

    Intuitive Surgical is recalling da Vinci instrument flush ports to clarify existing labeling and operating procedures.

    Product
    Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1413-2013·2013-06-05

    Spinal Solutions Recalls 50 mm Rods Due to Missing Surgical Instructions

    Spinal Solutions is recalling 55 units of 50 mm Rods because directions for use and surgical techniques were not provided to every physician.

    Product
    50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1463-2013·2013-06-05

    Red Bone Alley Wasabi Sauce Recalled for Undeclared Metabisulfite

    National Food & Beverage, Inc. is recalling Red Bone Alley Wasabi Sauce due to undeclared metabisulfite. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    Red Bone Alley Restaurant Wasabi All Natural Sauce for all Seafood & Chicken, Net Wt. 12 fl oz. Distributed by: Red Bone Alley Foods, LLC, 1903 W. Palmetto Street, Florence, SC 29501. Clear Plastic (Pet) Ring Neck Round bottle with neck band with white screw top cap. 6/12oz…
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1375-2013·2013-06-05

    Intel-GE QuietCare Recall Issued for Duplicate Alert Functionality

    Intel-GE Care Innovations LLC is recalling QuietCare monitoring systems because customers reported receiving duplicate alerts. The recall affects 1,722 units distributed in the US and Great Britain.

    Product
    QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-486-2013·2013-06-05

    Nora Apothecary Recalls Methylcobalamin Injections Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Methylcobalamin Inj 2.5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1382-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions

    Orthopedic Alliance LLC is recalling 21 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.

    Product
    Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral head, long, ¿26mm, +6mm Femoral head, X-long, ¿26mm, +9mm Femoral head, ¿28mm, -3mm Femoral head, ¿28mm, +0mm Femoral head, ¿28mm, +5mm Femoral head, ¿28mm, +10mm Femoral head, ¿32mm, -3mm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1417-2013·2013-06-05

    Spinal Solutions Recalls Copperhead IBFD Loaner Bins Due to Missing Instructions

    Spinal Solutions is recalling Copperhead IBFD loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.

    Product
    Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead IBFD, Large Neutral, 9mm Copperhead IBFD, Large Neutral, 10mm Copperhead IBFD, Large Neutral, 11mm Product Usage: Spinal Solutions distributes a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1386-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions

    Orthopedic Alliance LLC is recalling 26 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician for every surgery.

    Product
    Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball Head, 32 Long CERAMIC Ball Head, 28 Short CoCr Ball Head, 28 Medium CoCr Ball Head, 28 Long CoCr Ball Head, 28 X-Long CoCr…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1414-2013·2013-06-05

    Spinal Solutions Recalls 60 mm Rods Due to Missing Surgical Instructions

    Spinal Solutions is recalling 72 units of 60 mm Rods because directions for use and surgical techniques were not provided to every physician.

    Product
    60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1425-2013·2013-05-29

    Full Circle Organic Cranberry Juice Blend Recalled for Patulin

    Clement Pappas & Co. is recalling Full Circle Organic 100% Cranberry Juice Blend because an ingredient contained patulin levels between 57.4 and 100 ppb.

    Product
    Full Circle Organic 100 % Cranberry Juice Blend 64 FL OZ (2 QT) 1.89 L UPC 03600079045 Distributed by Topco Associates LLC 7711 Gross Point Road, Skokie, Illinois 60077 www.fullcirclefoods.com
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1360-2013·2013-05-29

    Progressive Medical Recalls PTFE Coated Laparoscopic Electrosurgical Electrodes

    Progressive Medical is recalling PTFE coated laparoscopic electrosurgical electrodes because the product coatings require 510K approval.

    Product
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J Hook 33cm Length, Product number P0021, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-430-2013·2013-05-29

    Levoxyl Levothyroxine Sodium Tablets Recalled for Low Potency

    King Legacy is recalling Levoxyl (levothyroxine sodium) 175 mcg tablets because they were below specification for potency at the expiry stability point.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1422-2013·2013-05-29

    Wegmans Organic Apple Juice Recalled for Patulin Contamination

    Clement Pappas & Co. is recalling Wegmans Organic Apple Juice because it contains patulin levels between 57.4 and 100 ppb.

    Product
    Wegmans Organic Apple Juice 64 FL OZ (2 QT) 1.89 L UPC 077890206058 Distributed by: Wegmans Food Markets, Inc. Rochester, NY 14603
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-425-2013·2013-05-29

    Levoxyl Levothyroxine Sodium Tablets Recalled for Low Potency

    King Legacy is recalling Levoxyl tablets because they were below specification for potency at the expiry stability point.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-445-2013·2013-05-29

    Lloyd Inc. of Iowa Recalls Levothroid Tablets Due to Quality Deviations

    Lloyd Inc. of Iowa is recalling Levothroid tablets due to cGMP deviations and insufficient stability data. The recall covers 142,103 bottles distributed nationwide and to Puerto Rico.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 100 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1323-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1354-2013·2013-05-29

    Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes

    Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.

    Product
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Blade 2.50" (6.40cm) Length, Product number P0012M Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-440-2013·2013-05-29

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to Quality Deviations

    Lloyd Inc. of Iowa is recalling bulk Thyro-Tab 0.125 mg tablets due to cGMP deviations and insufficient stability data.

    Product
    Lloyd Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-427-2013·2013-05-29

    Levoxyl tablets recalled for subpotent levothyroxine sodium

    King Legacy is recalling Levoxyl tablets because they were below specification for potency at the expiry stability point.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide