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.

13276–13300 of 21617

  • ModerateFDA (Devices)·Z-0960-2017·2017-01-18

    Trilliant Tiger Screw Sterilization Tray Base Assembly Recall for Printing Error

    Trilliant Surgical Ltd. is recalling Tiger Screw Sterilization Tray Base Assemblies due to a printing error on k-wire description markings.

    Product
    Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0993-2017·2017-01-18

    Siemens Biograph mCT Scanners Recalled for Falling Laser Cover Windows

    Siemens is recalling 34 Biograph mCT scanners because laser cover windows may fall off, posing a potential hazard to users.

    Product
    Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0981-2017·2017-01-18

    Bard Access Systems Recalls StatLock PICC Plus Devices Due to Missing Identifiers

    Bard Access Systems is recalling StatLock PICC Plus Crescent Foam devices because some pouches lack unique product identifiers like lot numbers.

    Product
    StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0974-2017·2017-01-18

    GE OEC MiniView 6800 C-Arm Recalled for Power Cable Failures

    GE Healthcare is conducting a voluntary field action for OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 devices due to intermittent power cord failures.

    Product
    OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for…
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0982-2017·2017-01-18

    Bard Access Systems Recalls StatLock Catheter Stabilization Devices

    Bard Access Systems is voluntarily recalling StatLock CV Plus catheter stabilization devices because some pouches lack unique product identifiers.

    Product
    StatLock¿ CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0971-2017·2017-01-18

    Siemens Artis zee/zeego Angiographic X-ray System Recall for Generator Defects

    Siemens is recalling Artis zee/zeego angiographic x-ray systems due to potential high-voltage generator failures and rare image display loss.

    Product
    Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0985-2017·2017-01-18

    Bard Access Systems Recalls MiniLoc Safety Infusion Sets Due to Labeling Errors

    Bard Access Systems is recalling MiniLoc Safety Infusion Sets because some units have needle lengths and gauges that differ from the label descriptions.

    Product
    MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc¿ trays per case and 160 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1016-2017·2017-01-18

    Hospira Recalls Minibore Extension Sets Due to Solvent Occlusion

    Hospira is voluntarily recalling one lot of Minibore Extension Sets due to a confirmed report of solvent occlusion that may prevent priming and delay therapy.

    Product
    Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0998-2017·2017-01-18

    Siemens Biograph mCT PET/CT Scanner Laser Cover Window Recall

    Siemens Medical Solutions is recalling Biograph mCT PET/CT scanners because laser cover windows may fall off.

    Product
    Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0980-2017·2017-01-18

    ICU Medical Recalls 24-Hour Primary Sets with Incorrect Drip Chambers

    ICU Medical is recalling 225 units of 24-hour primary sets where a 15-drop drip chamber was installed instead of the required 60-drop chamber.

    Product
    133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0973-2017·2017-01-18

    GE Healthcare Recalls OEC 9800 Imaging Systems Due to Power Cable Failures

    GE Healthcare is conducting a voluntary field action for OEC 9800 systems because the workstation power cable assembly can cause intermittent power cord failures.

    Product
    OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic…
    Category
    Medical Device
    Distribution
    50 states
  • ModerateUSDA FSIS·006-2017·2017-01-18

    Burgers Ozark Country Cured Recalls Mislabeled Turkey Products

    Burgers Ozark Country Cured is recalling approximately 1,905 pounds of fully cooked turkey products due to misbranding. The products contain undeclared sodium nitrite.

    Product
    Burger's Ozark Country Cured Hams, Inc. — Burgers Ozark Country Cured Recalls Poultry Products Due To Misbranding
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1091-2017·2017-01-18

    Piazza Produce Recalls Chili Powder for Missing Ingredient Labeling

    Piazza Produce, Inc. is recalling various sizes of chili powder because the product labeling does not contain a listing of ingredients.

    Product
    Chili Powder, 5 lb plastic gallon, product number 62235; Chili Powder, 1.25 lb plastic jar, product number 62216; Chili Powder, 10 lb plastic pail, product number 62254; Chili Powder, 22 lb plastic pail, product number 62273
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0986-2017·2017-01-18

    Bard Access Systems Recalls SafeStep Huber Needle Sets Due to Labeling Errors

    Bard Access Systems is recalling SafeStep Huber Needle Sets because some units may have needle lengths or gauges that differ from the label.

    Product
    SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep¿ trays per case and 100 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0996-2017·2017-01-18

    Siemens Biograph mCT PET/CT Scanners Recalled for Falling Laser Cover Windows

    Siemens Medical Solutions is recalling 102 Biograph mCT PET/CT scanners because laser cover windows may fall off.

    Product
    Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1245-2017·2017-01-18

    Fabi-saa Melcochas Candy Recalled Due to Undeclared Yellow #5 Dye

    Fabi-saa Inc. is recalling Melcochas Candy because analysis revealed the presence of Yellow #5 dye, which was not declared on the label.

    Product
    Fabi-saa Melcochas Candy Net Wt. 8 oz. Fabi-Saa Inc. 39 Montgomery Street Belleville, NJ 07936 UPC 181683000676
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1000-2017·2017-01-18

    Siemens Biograph mCT 20 Excel PET/CT Scanner Recall for Laser Cover Windows

    Siemens is recalling 51 Biograph mCT 20 Excel scanners because laser cover windows may fall off.

    Product
    BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0955-2017·2017-01-18

    VOCO Futurabond M+ adhesive recalled for labeling mix-up

    Voco GmbH is recalling 50 units of VOCO Futurabond M+ adhesive due to a labeling error where the product was marked as Futurabond M+ Universal Adhesive.

    Product
    VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use with methacrylate-based restorative, core build-up or luting materials. It can be applied with phosphoric acid etching (selective enamel etching or total-etch) of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0429-2017·2017-01-18

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the delivery system failed to meet mechanical specifications.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0427-2017·2017-01-18

    Pharm D Solutions Recalls HCG-Vitamin B12 Injection Due to Labeling Error

    Pharm D Solutions is recalling 112 vials of HCG-Vitamin B12 injection because the product description incorrectly states the HCG strength as 7500 units instead of 5000 units.

    Product
    HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1723-20
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0994-2017·2017-01-18

    Siemens Biograph mCT X-4R Laser Cover Window Recall

    Siemens is recalling 71 Biograph mCT X-4R scanners because laser cover windows may fall off.

    Product
    Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0983-2017·2017-01-18

    Bausch & Lomb Recalls Algerbrush-II Ophthalmic Surgical Instruments

    Bausch & Lomb is recalling Algerbrush-II surgical instruments because some units shipped with outdated operating instructions.

    Product
    Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0992-2017·2017-01-18

    Siemens Biograph mCT PET/CT Scanner Laser Cover Window Recall

    Siemens is recalling 41 Biograph mCT PET/CT scanners because laser cover windows may fall off.

    Product
    Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1019-2017·2017-01-18

    Acumed Recalls OPT Croutons Synthetic Bone Substitute Due to Sterilization Documentation Issues

    Acumed LLC is recalling 83 units of OPT Croutons synthetic bone substitute because documentation for the sterilization dose was inadequate. The product was distributed in ten US states and Puerto Rico.

    Product
    OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Food)·F-1179-2017·2017-01-18

    Starkey Spring Water Recalled Due to Arsenic Detection

    Starkey Water is recalling 16.9 fl oz glass bottles of Starkey Spring Water because 11.7 ppb of arsenic was detected in a water sample.

    Product
    Starkey Spring Water, Item code STC.5, 16.9 FL oz. (500 mL) glass bottle. Product UPC 8 11904 02000 7. Case UPC 8 11904 02002 1.
    Category
    Food
    Distribution
    4 states