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.

15651–15675 of 21645

  • ModerateFDA (Food)·F-0111-2016·2015-11-04

    Sobisk Orange Cream Cookies Recalled for Undeclared Food Dyes

    Sobisk Foods LLC is recalling Orange Cream Cookies imported from India because they contain undeclared food dyes, including FD & C Red #3, Yellow #5, and #6.

    Product
    Sobisk Orange Cream Cookies; Imported Exclusively by: Sobisk Foods, LLC, 110 W Baltimore Ave, Clifton heights, PA 19018; Product of India;;; BEST BY: 03/31/2017 Net Wt: 11.04 oz package 10 Packs and/or Net Wt: 9.1 oz. 8 Packs.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0167-2016·2015-11-04

    Synthes 2.7 mm Locking Screws Recalled for Mislabeling as 2.4 mm

    Synthes (USA) Products LLC is recalling 98 units of 2.7 mm locking screws that were mislabeled as 2.4 mm. The units were distributed to Tennessee.

    Product
    2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0164-2016·2015-11-04

    Sentinel Ammonia Reagent Recalled for Inaccurate Results in Heparin Tubes

    Sentinel CH SpA is recalling 765 kits of Sentinel MULTIGENT Ammonia Ultra Reagent because results may be below the linear range for samples collected in heparin tubes.

    Product
    Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0110-2016·2015-11-04

    Sobisk Lemon Cream Cookies Recalled for Undeclared Color Additive

    Sobisk Foods LLC is recalling Lemon Cream Cookies imported from India because they contain undeclared FD & C Yellow #5.

    Product
    Sobisk Lemon Cream Cookies; Imported Exclusively by: Sobisk Foods, LLC, 110 W Baltimore Ave, Clifton heights, PA 19018; Product of India;;; BEST BY: 1/31/2017 Net Wt: 11.04 oz package 10 Packs and/or Net Wt: 9.1 oz. 8 Packs.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0174-2016·2015-11-04

    Philips Recalls Brilliance 64 CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 108 Brilliance 64 CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts.

    Product
    Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0175-2016·2015-11-04

    Philips Ingenuity Core CT Systems Recalled for X-ray Measurement Error

    Philips is recalling 36 Ingenuity Core CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts in images.

    Product
    Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2016·2015-11-04

    Philips Recalls Brilliance 16-Slice CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 323 Brilliance 16-Slice CT systems worldwide due to X-ray measurement errors causing Ring/Dot artifacts.

    Product
    Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0170-2016·2015-11-04

    Varian ARIA Radiation Oncology Software Recall for Printing Anomaly

    Varian Medical Systems is recalling ARIA Radiation Oncology software versions 10, 11, 13.0, and 13.5 because admin instructions may fail to print or transmit.

    Product
    ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0178-2016·2015-11-04

    Philips Recalls Ingenuity Flex CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 67 Ingenuity Flex CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts in images.

    Product
    Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0161-2016·2015-11-04

    Nipro Safe Touch TULIP Safety Fistula Needle Packaging Error Recall

    Nipro Medical Corporation is recalling 50,000 fistula needles because some 1 1/4-inch needles were packaged in 1-inch blister packs.

    Product
    Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0172-2016·2015-11-04

    Spacelabs CardioCall ECG Event Recorders Recalled for Battery Defect

    Spacelabs Healthcare is recalling CardioCall ECG Event Recorders because a battery defect causes continuous ringing and prevents normal operation.

    Product
    Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0165-2016·2015-11-04

    Encore Medical Recalls Exprt Precision System Knee Implants for Missing Labeling

    Encore Medical is recalling 209 Exprt Precision System Revision Knee implants because the labeling is missing size and diameter information.

    Product
    Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Drugs)·D-0054-2016·2015-10-28

    Hospira Recalls Amidate Etomidate Injection Due to Degradation Impurities

    Hospira Inc. is recalling 24,100 syringes of Amidate (Etomidate Injection) because stability testing confirmed out-of-specification degradation products.

    Product
    Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0131-2016·2015-10-28

    Encore Medical Recalls AltiVate Humeral Socket Shell Trial Due to Assembly Issues

    Encore Medical is recalling 20 units of the AltiVate Humeral Socket Shell Trial because the shell trial has difficulty assembling to the broach and the retaining ring disassembles from the screw.

    Product
    AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemented or cementless use. This device may also be indicated in the salvage of…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0143-2016·2015-10-28

    ConForMIS iDuo Knee Replacement Recalled for Ethylene Glycol Residue

    ConforMIS, Inc. is recalling 12 units of the iDuo Knee Bicompartmental Knee Replacement System because they may contain small amounts of ethylene glycol residue.

    Product
    ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0152-2016·2015-10-28

    Smiths Medical Recalls Port-A-Cath Needles Due to Incorrect Labeling

    Smiths Medical ASD, Inc. is recalling Port-A-Cath Plastic Hub Needles from Lot 46262 because the lid stock labels contain incorrect part numbers, descriptions, and images.

    Product
    PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal system for the purpose of infusion or withdrawal of fluids. These PAC needles can be used with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0147-2016·2015-10-28

    ConFormis iTotal Knee Replacement System Recalled for Ethylene Glycol Residue

    ConforMIS is recalling 110 units of the iTotal Posterior Stabilized Knee Replacement System because they may contain small amounts of ethylene glycol residue.

    Product
    ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0028-2016·2015-10-28

    Wismettac Asian Food Recalls Seasoned Beanthread Salad for Regulatory Filing Issues

    Wismettac Asian Food is recalling Seasoned Beanthread Salad (Chuka Zensai) due to a lack of required acidified food filing and registration.

    Product
    Seasoned Beanthread Salad (CHUKA ZENSAI), net wt. 2.2 lbs (1kg), Item No. 82021. Chinese style appetizer labeled as SEASONED BEANTHREAD SALAD (CHUKA ZENSAI) packed in 1 kg clear plastic bags and placed in cardboard cartons containing twelve (12) bags per carton. The bags…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0137-2016·2015-10-28

    Biomet Thinflap System Cases Recalled Due to Lid Opening Difficulty

    Biomet Microfixation is recalling 5 Thinflap System Cases because the lids require excessive force to open.

    Product
    Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0134-2016·2015-10-28

    Synthes Recalls Spinal Pedicle Fixation Rods Due to Finishing Process Error

    Synthes (USA) Products LLC is recalling 492 spinal pedicle fixation rods because they were produced using a bead blast process not identified in the manufacturing specification.

    Product
    5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, 5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation Intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0144-2016·2015-10-28

    ConFormis iTotal CR Knee Replacement System Recalled for Ethylene Glycol Residue

    ConforMIS, Inc. is recalling 3 units of the iTotal CR Knee Replacement System because they may contain small amounts of ethylene glycol residue.

    Product
    ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0035-2016·2015-10-28

    JBN Chocolate Whey Protein Powder Recalled for Missing Milk Labeling

    Nutrition Resource Services is recalling JBN Chocolate Confidence Nutritional Support for Bariatric Surgery because the whey protein product is not labeled as containing milk.

    Product
    JBN (Just Be Natural) Chocolate Confidence Nutritional Support for Bariatric Surgery 25G 100% WHEY ISOLATE; NET WT. 43.4 oz. (2.7 lb) 1,230g - packaged in plastic bottles, UPC code: 655455018225, DIETARY SUPPLEMENT MANUFACTURED BY NRS -Nutrition Resource Services, Inc.…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0150-2016·2015-10-28

    B. Braun Recalls Perifix Epidural Anesthesia Trays Due to Discoloration

    B. Braun Medical is recalling 433 Perifix Continuous Epidural Anesthesia Pain Control Trays because the DuraPrep solution may be discolored from unintended sterilant exposure.

    Product
    Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0146-2016·2015-10-28

    ConFormis iTotal CR Knee Replacement System Recalled for Ethylene Glycol Residue

    ConforMIS, Inc. is recalling 348 units of the iTotal CR Knee Replacement System because they may contain small amounts of ethylene glycol residue.

    Product
    ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0153-2016·2015-10-28

    OneTray Sealed Sterilization Containers Recalled for Incorrect Labeling

    Innovative Sterilization Technologies LLC is recalling OneTray Sealed Sterilization Containers because the labels list the wrong steam sterilization time.

    Product
    OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
    Category
    Medical Device
    Distribution
    Distributed nationwide