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.

20751–20775 of 21633

  • ModerateFDA (Devices)·Z-0910-2013·2013-03-13

    Bard Access Systems Recalls Dual Lumen Catheters Due to Wrong Introducer Size

    Bard Access Systems is recalling specific lots of Hickman and Leonard catheters because the kits included the wrong size introducer.

    Product
    Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0912-2013·2013-03-13

    Atricure Max1 Isolator Transpolar Pen Recalled for Incorrect Labeling

    Atricure Inc. is recalling five Max1 Isolator Transpolar Pens due to incorrect Instructions for Use labeling.

    Product
    Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0915-2013·2013-03-13

    Steris Recalls Amsco Steam Sterilizers Due to Erroneous Alarm Activation

    Steris Corporation is recalling Amsco C and Amsco 400 steam sterilizers because control board defects cause erroneous alarms that lock up the devices.

    Product
    AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0903-2013·2013-03-13

    Synthes Multi-Vector Distractor Body Recalled for Manufacturing Defect

    Synthes USA HQ, Inc. is recalling two units of the Multi-Vector Distractor Body because the sheer pin may not meet product specifications.

    Product
    Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0909-2013·2013-03-13

    Bard Access Systems Recalls Hickman and Leonard Catheters Due to Wrong Introducer Size

    Bard Access Systems is recalling specific lots of Hickman and Leonard catheters because the kits included the wrong size introducer.

    Product
    Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0904-2013·2013-03-13

    Synthes Multi-Vector Distractor Recalled Due to Shear Pin Specification Issues

    Synthes USA is recalling 24 Multi-Vector Distractors because the sheer pin may not meet product specifications. The devices are used for mandibular bone lengthening.

    Product
    Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1046-2013·2013-03-13

    Tortilleria Provincia Yellow Corn Tortillas Recalled for Unlabeled Dye

    Tortilleria Provincia is recalling yellow corn tortillas because they contain FD&C Yellow #5, which is not listed on the ingredient label.

    Product
    Yellow Corn Tortillas in 5 lb clear flexible plastic bags with green and yellow printing. Tortilleria Provincia 1200 B Clay Street Bowling Green, KY 42101
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-181-2013·2013-03-13

    Bristol Myers Squibb Recalls Abilify Tablets Due to Manufacturing Error

    Bristol Myers Squibb is recalling specific Abilify 30 mg tablets because rejected material was inadvertently shipped. The affected product was distributed in LA, TN, and CA.

    Product
    ABILIFY — ABILIFY (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0786-2013·2013-03-06

    Philips CT Systems Recalled for Deteriorating Image Quality Phantom Pins

    Philips Medical Systems is recalling 1,474 CT scanners because low-contrast pins in the Image Quality phantom deteriorate, preventing required daily checks.

    Product
    Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1006-2013·2013-03-06

    Whole Foods Market Panettone Chocolate Recalled for Mispackaging

    Whole Foods Market is recalling Panettone Chocolate because some units were mispackaged with Cranberry Panettone, creating a potential soy allergen discrepancy.

    Product
    Whole Foods Market Panettone Chocolate - 26.4 oz, 12 per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0873-2013·2013-03-06

    KY Sensitive Jelly Personal Lubricant Recalled for Lack of FDA Clearance

    McNeil-PPC Inc. is recalling KY Sensitive Jelly Personal Lubricant because the product is not cleared for marketing in the US.

    Product
    KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0884-2013·2013-03-06

    Philips DigitalDiagnost X-Ray System Recalled for Image Rotation Errors

    Philips Healthcare Inc. is recalling 551 DigitalDiagnost X-Ray Systems because images may rotate in the wrong direction, causing electronic side markers to be placed incorrectly.

    Product
    Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0882-2013·2013-03-06

    Philips GEMINI PET/CT Systems Recalled for Software Data Flipping Error

    Philips is recalling 30 GEMINI PET/CT systems because a software error causes Intensity Projection data to be flipped and mislabeled left-to-right.

    Product
    Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations…
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Drugs)·D-174-2013·2013-03-06

    West-ward Recalls Isoniazid Tablets for Failed Dissolution Specifications

    West-ward Pharmaceutical Corp. is recalling Isoniazid Tablets 300 mg due to failed dissolution specifications and a 36-month stability timepoint issue.

    Product
    Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-172-2013·2013-03-06

    Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Amedra Pharmaceuticals is recalling 12,948 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications over their shelf life.

    Product
    Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0879-2013·2013-03-06

    Baylis Medical Recalls Unsealed Sterile RF Cannulas for Pain Relief

    Baylis Medical is recalling 1,780 sterile RF cannulas distributed to Australia because some pouches were not sealed, risking sterility loss.

    Product
    BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-180-2013·2013-03-06

    Dr. Reddy's Recalls Citalopram Tablets Due to Chemical Odor Complaints

    Dr. Reddy's is recalling specific lots of Citalopram tablets because patients reported a strong garlic or chemical smell.

    Product
    Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-344-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0886-2013·2013-03-06

    Integra Jarit Monopolar Cable Recall for Updated Safety Warnings

    Integra LifeSciences is recalling 22,500 Jarit Monopolar Cables to distribute an addendum to the Instructions for Use. The update emphasizes existing warnings and adds new precautions for electrosurgical equipment.

    Product
    Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-173-2013·2013-03-06

    Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Amedra Pharmaceuticals is recalling 10,968 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications over the product shelf life.

    Product
    Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0898-2013·2013-03-06

    MedComp Recalls 785 PICC Kits Packaged with Incorrect Needles

    Medical Components, Inc. is recalling 785 power injectable infusion PICC insertion kits because they were packaged with non-safety needles instead of the safety needles indicated on the label.

    Product
    REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-170-2013·2013-03-06

    West-ward Recalls Belladonna Alkaloids Tablets Due to Foreign Substance

    West-ward Pharmaceutical Corp. is recalling Belladonna Alkaloids with Phenobarbital tablets because uncharacteristic black spots were found in the product.

    Product
    Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0761-2013·2013-03-06

    GE Healthcare Recalls Brivo XR385 X-Ray Systems Due to Software Issue

    GE Healthcare is recalling nine Brivo XR385 X-Ray systems in the US due to a software issue affecting visual indications required by regulations.

    Product
    GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1008-2013·2013-03-06

    Aptalis Recalls SourceCF Pediatric Multivitamin Drops Due to Shelf Life Concerns

    Aptalis Pharma is recalling SourceCF Pediatric Drops because the formulation may not support the labeled shelf life. The recall covers 14,439 units distributed in the US, Italy, Canada, and Brazil.

    Product
    SourceCF(R) Pediatric Drops, Multivitamins with A, B, D, E and K Plus Zinc, 2 FL OZ. (60ML), NDC 66212-300-60, UPC 668212300600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1022-2013·2013-03-06

    Koda Farms Recalls Sweet Rice Flour Due to Foreign Object

    Koda Farms is recalling 50 lb. bags of Mochiko Blue Star Sweet Rice Flour after a customer reported finding a hard yellow material in dough made with the product.

    Product
    Mochiko Blue Star Sweet Rice Flour; Net Wt. 50 lbs. (22.68 k) Koda Farms Milling, Inc. South Dos Palos, CA 93665
    Category
    Food
    Distribution
    2 states