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.

9751–9775 of 21595

  • ModerateFDA (Devices)·Z-0318-2019·2018-11-07

    Zilver 518 Biliary Stent recall issued due to incorrect instruction for use details

    The FDA is recalling the Zilver 518 Biliary Stent because its instruction for use details were incorrect, requiring updated deployment guidance.

    Product
    Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0342-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0110-2019·2018-11-07

    Sprayology Recalls Bone Builder Homeopathic Oral Spray Due to CGMP Deviations

    Sprayology is recalling Bone Builder Homeopathic Oral Spray because it was manufactured under conditions that could result in possible microbial contamination.

    Product
    Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0012-1 and Tester NDC 61096-1012-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0343-2019·2018-11-07

    Wegmans Recalls Hummus Due to Potential Plastic Foreign Material

    Wegmans is recalling specific lots of hummus because they may contain plastic. Consumers should check their pantry and stop eating the product.

    Product
    Wegmans Hummus, NET WT 32 OZ (2 LB) 908g, UPC: 77890-26221 and NET WT 8 OZ (227g), UPC: 77890-26213
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0116-2019·2018-11-07

    Sprayology Recalls Party Relief Homeopathic Oral Spray Due to CGMP Deviations

    Sprayology is recalling 2,956 bottles of Party Relief Homeopathic Oral Spray due to manufacturing conditions that could result in possible microbial contamination.

    Product
    Party Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0030-1 and Tester NDC 61096-1030-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0331-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0108-2019·2018-11-07

    Sprayology Recalls Woman Power Homeopathic Oral Spray Due to CGMP Deviations

    Sprayology is recalling 1,284 bottles of Woman Power Homeopathic Oral Spray due to manufacturing conditions that could result in microbial contamination.

    Product
    Woman Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-0034-1 and Tester NDC 61096-1034-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0345-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-80-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0326-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-125-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0319-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 5mm x 20mm, Catalog Number: ZIB5-125-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0348-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent for Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-80-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0339-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0322-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent for Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0071-2019·2018-10-31

    Cedar's Mediterranean Foods Recalls HEB Select Ingredients Roasted Garlic Hummus

    Cedar's Mediterranean Foods is recalling HEB Select Ingredients Roasted Garlic Hummus due to the presence of foreign material.

    Product
    HEB Select Ingredients ROASTED GARLIC HUMMUS PREMIUM QUALITY NET WT 8 OZ (227g) UPC 0 41220 33495 7 and NET WT. 16 OZ (1 LB) 454g), UPC 0 41220 67250 9
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0219-2019·2018-10-31

    Nakanishi Surgical Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 12 SGS-E surgical handpieces to replace operation manuals with updated reprocessing instructions for manual cleaning and autoclave sterilization.

    Product
    Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0100-2019·2018-10-31

    Teva Recalls Metformin Hydrochloride Extended Release Tablets Due to Defective Delivery System

    Teva Pharmaceuticals USA is recalling 82,291 bottles of Metformin Hydrochloride Extended Release Tablets 1000 mg because some tablets may be missing laser drilling, which could affect drug release.

    Product
    Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0275-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D an
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0228-2019·2018-10-31

    bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue

    bioMerieux is recalling 516 BACT/ALERT VIRTUO systems with R2.0 firmware because a service feature may leave calibration standards in incorrect locations, potentially causing anomalies.

    Product
    BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0101-2019·2018-10-31

    Teva Recalls Metformin Hydrochloride Extended Release Tablets Due to Defective Delivery System

    Teva Pharmaceuticals USA is recalling specific lots of Metformin Hydrochloride Extended Release Tablets 1000 mg because some tablets may be missing laser drilling, which could affect drug release.

    Product
    Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0057-2019·2018-10-31

    Lutosa Plain Mashed Potato Recall for Potential Foreign Objects

    Lutosa S.A. is recalling specific lots of Plain Mashed Potato due to potential plastic and rubber pieces.

    Product
    Lutosa Foodservice Quality Plain Mashed Produced in Belgium 2.5 kg/5.5 lb
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0231-2019·2018-10-31

    Ecolab recalls sterile instrument arm drapes due to potential seal defects

    Ecolab is recalling specific lots of sterile instrument arm drapes for the Da Vinci Si system because seal wrinkles may compromise sterility.

    Product
    Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system Distribute by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap vari
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0238-2019·2018-10-31

    Synthes 3.0mm Headless Compression Screws Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 20 units of 3.0mm Headless Compression Screws because the product inside the package does not match the label.

    Product
    3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0239-2019·2018-10-31

    Philips DigitalDiagnost Software Recall for X-ray System Stitching Defects

    Philips is recalling DigitalDiagnost software for stationary X-ray systems due to intermittent stitching interruptions and incorrect baseline data on the system CD.

    Product
    Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0130-2019·2018-10-31

    RXQ Compounding Recalls Subpotent Lidocaine and Epinephrine Injection Vials

    RXQ Compounding LLC is recalling 395 vials of Lidocaine 1% + Epinephrine 1:100,000 injection solution because testing revealed the product was subpotent.

    Product
    Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC 7073197450
    Category
    Drug
    Distribution
    Distributed nationwide