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.

13051–13075 of 21617

  • ModerateFDA (Devices)·Z-1480-2017·2017-03-22

    Philips BrightView Nuclear Imaging Systems Recalled for Motion and Software Issues

    Philips Medical Systems is recalling 1,218 BrightView nuclear imaging systems worldwide due to four issues, including motion controller failures and software freezes.

    Product
    882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1465-2017·2017-03-22

    Smiths Medical Recalls Mislabelled Pediatric Tracheostomy Tubes

    Smiths Medical is recalling 142 Bivona TTS Pediatric Tracheostomy Tubes because they were incorrectly labeled for neonatal use instead of pediatric use.

    Product
    Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-1444-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Symbol

    LeMaitre Vascular is recalling 608 Reddick Cholangiogram Catheters because the latex warning symbol was not printed on the packaging.

    Product
    LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1466-2017·2017-03-22

    Siemens Artis Q and Q.Zen Fluoroscopic X-Ray System Recall

    Siemens is recalling Artis Q and Q.Zen fluoroscopic x-ray systems because a gap in the wireless foot switch housing could allow liquids to penetrate the interior, potentially causing the switch to fail.

    Product
    Artis Q and Q.Zen fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1597-2017·2017-03-22

    Batch International Recalls Chocolate Truffles Due to Allergen Labeling

    Batch International LLC is recalling assorted chocolate truffles because allergens are listed on an internal insert rather than the exterior box.

    Product
    Assorted chocolate truffles, packaged in Kraft colored boxes with the Batch PDX sticker. Boxes contain 5, 8, 12, 18, 24 or 32 pieces with any combination of the following 14 flavors: 1. Vietnamese Iced Coffee 2. Raspberry 3. Spicy Passion 4. Bull Run Bourbon 5. Mint…
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1451-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Symbol

    LeMaitre Vascular is recalling 247 units of Scoop Tip Cholangiogram Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1603-2017·2017-03-22

    Sweets & Desserts Recalls Tres Leches Cakes for Undeclared Food Colors

    Sweets & Desserts, Inc. is recalling Tres Leches cakes in Puerto Rico because they contain undeclared food colors.

    Product
    The Sweet Dessert Corp., Tres Leches (Three Milk Cake), Peso Neto (Net Weight) 3oz and 4 oz., and 4oz (large label) Carr. 173 Km 7.1 Bo. Sumidero, Aguas Buenas, P.R. 00703
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1469-2017·2017-03-22

    GE OEC FlexiView 8800 Imaging System Recalled for Power Cord Failures

    GE is recalling OEC FlexiView 8800 systems where specific power cords were replaced in 2016 due to intermittent failures causing loss of imaging functionality.

    Product
    OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1458-2017·2017-03-22

    Terumo Level Sensor II Pads Recalled for Non-Compliant Expiration Date Labeling

    Terumo Cardiovascular Systems Corporation is voluntarily recalling Level Sensor II Pads because the expiration date format may not be recognizable to all users.

    Product
    Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1478-2017·2017-03-22

    Inion GRT Tack Recall Due to Defective Aluminum Pouch Seal

    Inion Ltd. is recalling 36 sterile Inion GRT Tack kits distributed in Florida and North Carolina because the aluminum pouch seal was found to be slightly open.

    Product
    Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0542-2017·2017-03-22

    Synergy Rx Recalls Retinoic Acid Solution Due to Sterility Concerns

    Synergy Rx is recalling all lots of Retinoic Acid Solution due to a lack of assurance of sterility and CGMP deviations.

    Product
    RETINOIC ACID SOLUTION in all strengths including 0.3%, 0.4%, 0.5%, 1%, RETINOIC ACID SOLUTION LIQUID, 0.4%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0592-2017·2017-03-22

    Synergy Rx Recalls RETIN-A 0.05% Cream Due to Sterility Concerns

    Synergy Rx is recalling RETIN-A 0.05% Cream because of a lack of assurance of sterility and CGMP deviations.

    Product
    RETIN-A 0.05% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1459-2017·2017-03-22

    Terumo Level Sensor Gel Pads Recalled for Non-Compliant Labeling

    Terumo is voluntarily recalling Level Sensor II Gel Pads because the expiration date format may not be recognizable to all users.

    Product
    Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0595-2017·2017-03-22

    Synergy Rx Recalls Metronidazole and Azelaic Acid Products for Sterility Concerns

    Synergy Rx is recalling Metronidazole 1% Gel and Metronidazole/Niacinamide/Azelaic Cream due to lack of assurance of sterility and CGMP deviations.

    Product
    METRONIDAZOLE 1% GEL, METRONIDAZOLE 1%/ NIACINAMIDE 4%/ AZELAIC CREAM 10% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1457-2017·2017-03-22

    Merge Hemo software recalled due to study tab locking issue

    Merge Healthcare is recalling Merge Hemo software versions 6.10 through 9.40.3 because the system may incorrectly lock study tabs, potentially preventing access to data.

    Product
    Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1450-2017·2017-03-22

    LeMaitre Vascular Scoop Tip Cholangiogram Catheter Recalled for Missing Latex Symbol

    LeMaitre Vascular is recalling 4,673 units of Scoop Tip Cholangiogram Catheters because the latex warning symbol was not printed on the packaging.

    Product
    LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0538-2017·2017-03-22

    Synergy Rx Fluocinonide Solution Recalled for Sterility Assurance Issues

    Synergy Rx is recalling Fluocinonide 0.05% Solution due to a lack of assurance of sterility and CGMP deviations.

    Product
    FLUOCINONIDE 0.05% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0532-2017·2017-03-22

    Synergy Rx Recalls Betamethasone Creams and Ointments for Sterility Concerns

    Synergy Rx is recalling various betamethasone cream and ointment products due to a lack of assurance of sterility and CGMP deviations.

    Product
    BL 20%/4% CREAM, BLT 20%/6%/4% CREAM, BLT 20%/6%/6%, BLT 20% 8% 4% CREAM, BLT 20% 8% 4% OINTMENT, BLT 20% 8% 6% CREAM, BLT 20%/ 8% /8% OINTMENT, BLT 20%/ 8% /8% CREAM, BLT 20%/ 7%/ 7% CREAM, BLT 20%/ 10%/ 4% CREAM, BLT 20%/ 10%/ 10% CREAM, BLT 20%/ 20%/ 10% OINTMENT,BLT 7%…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0582-2017·2017-03-22

    Synergy Rx Enhanced Retin Cream Recalled for Sterility Assurance Issues

    Synergy Rx is recalling Enhanced Retin Anti-Wrinkle Cream due to lack of assurance of sterility and CGMP deviations.

    Product
    ENHANCED RETIN ANTI-WRINKLE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1441-2017·2017-03-22

    RTI Biologics BioSet IC RT Paste Recalled for Incorrect Instructions

    RTI Surgical is recalling 24 units of BioSet IC RT Paste due to incorrect instructions for use. The product was distributed in Colombia.

    Product
    RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1463-2017·2017-03-22

    Radiometer ABL800 Blood Gas Analyzer Recall for Sample Type Change

    Radiometer America Inc. is recalling ABL800 analyzers because the 'cord blood' sample type was changed to 'cord blood arterial' and 'cord blood venous.'

    Product
    The ABL800 Model#:All
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1445-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Labeling

    LeMaitre Vascular is recalling 250 units of Reddick Cholangiogram Stiffer Catheters because the latex warning symbol was not printed on the packaging.

    Product
    LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0558-2017·2017-03-22

    Synergy Rx Recalls Generic VI Peel Due to Sterility Concerns

    Synergy Rx is recalling Generic VI Peel products nationwide due to a lack of assurance of sterility and CGMP deviations.

    Product
    GENERIC VI PEEL (Sal Acid 2%, TCA 7% Phenol 7%, Retinoic Acid 0.4%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1467-2017·2017-03-22

    Siemens Artis Zee and Zeego Fluoroscopic X-Ray System Recall

    Siemens is recalling Artis Zee and Zeego fluoroscopic x-ray systems because a gap in the wireless foot switch housing could allow liquids to penetrate the interior, potentially causing the switch to fail.

    Product
    Artis Zee and Zeego fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide