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.

9776–9800 of 21595

  • 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-0223-2019·2018-10-31

    Nakanishi SGS-ES Micro Surgery Handpiece Recall for Updated Instructions

    Nakanishi Inc. is recalling 2,419 SGS-ES Micro Surgery Handpieces to replace operation manuals with updated reprocessing and sterilization instructions.

    Product
    Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: 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 (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
  • ModerateFDA (Devices)·Z-0196-2019·2018-10-31

    Medacta MiniMAX Cementless Hip Stem Recalled for Packaging Breach

    Medacta USA Inc. is recalling 837 units of MiniMAX Cementless Anatomical Stems because complaint monitoring identified a trend of packaging breaches.

    Product
    Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0233-2019·2018-10-31

    Ecolab Recalls Disposable Accessory Kits for Da Vinci Robotic System

    Ecolab Inc is recalling specific lots of Disposable Accessory Kits, 3-Arm, due to potential pouch seal defects that could compromise sterility.

    Product
    Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0069-2019·2018-10-31

    Cedar's Mediterranean Foods Recalls Hummus Due to Foreign Material

    Cedar's Mediterranean Foods is recalling Central Market All Natural Mediterranean Hummus because it contains foreign material. The product was distributed directly to Texas.

    Product
    Central Market All Natural Mediterranean Hummus, NET WT 10 OZ (284g), UPC: 0 41220 91513 2
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0237-2019·2018-10-31

    Micro-Tech Recalls Single-Use Biopsy Forceps Due to Incorrect Product Contents

    Micro-Tech (Nanjing) Co., Ltd. is recalling 1,360 units of Single-Use Biopsy Forceps because the boxes contained Grasping Forceps instead of the labeled product.

    Product
    Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF40182 (Carton box level) - BF40183(Over shipper level), STERILE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0089-2019·2018-10-31

    Westlab Pharmacy Recalls Alprostadil Injectable Vials Due to Incorrect Formulation

    Westlab Pharmacy is recalling 80 vials of Alprostadil 500 mcg/mL Injectable due to an incorrect product formulation. The recall covers nationwide distribution.

    Product
    Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0085-2019·2018-10-31

    Valeant Recalls Cortaid Maximum Strength Cream Due to cGMP Deviations

    Valeant Pharmaceuticals is recalling specific lots of Cortaid Maximum Strength Cream due to current Good Manufacturing Practice (cGMP) deviations identified during a supplier review.

    Product
    Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875521011
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0224-2019·2018-10-31

    Nakanishi SGS Surgical Handpieces Recalled for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 1,662 SGS-E2S surgical handpieces because reprocessing instructions were updated to include manual cleaning and specific autoclave parameters.

    Product
    Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: 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 (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 (Drugs)·D-0084-2019·2018-10-31

    Valeant Recalls Cortaid Intensive Therapy Cooling Spray Due to cGMP Deviations

    Valeant Pharmaceuticals is recalling specific lots of Cortaid Intensive Therapy Cooling Spray due to cGMP deviations identified after a supplier recall for microbial contamination.

    Product
    Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875518028
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0225-2019·2018-10-31

    Nakanishi Micro Surgery Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 440 Micro Surgery Handpiece SGA units because reprocessing instructions have been updated. Previous operation manuals must be replaced.

    Product
    Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: 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-0281-2019·2018-10-31

    Upsher Smith Recalls Bumetanide Tablets for Unspecified Degradation Product

    Upsher Smith Laboratories is recalling 29,080 bottles of Bumetanide 2 mg tablets because the product failed impurity specifications for an unspecified degradation product.

    Product
    BUMETANIDE — BUMETANIDE (BUMETANIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0235-2019·2018-10-31

    Stryker Altrix Temperature Management System Recalled for Alarm Faults

    Stryker is recalling 389 Altrix Precision Temperature Management Systems due to frequent alarms and mechanical interference faults.

    Product
    Altrix¿ Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0227-2019·2018-10-31

    Terumo Recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System

    Terumo is recalling 135 units of the VirtuoSaph Plus Endoscopic Vessel Harvesting System because one energy platform is not compatible with the device.

    Product
    VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0222-2019·2018-10-31

    Nakanishi Surgical Handpieces Recalled for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling six SGA-E2G surgical handpieces because reprocessing instructions have been updated to include manual cleaning and specific autoclave parameters.

    Product
    Surgical Handpiece, Model: SGA-E2G Order Code: H184, 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-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