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.

10476–10500 of 21617

  • ModerateFDA (Devices)·Z-1935-2018·2018-06-06

    Medline Sterile Needle Counter Recall Due to Packaging Seal Creep

    Medline Industries is recalling sterile needle counters because packaging seal creep may compromise sterility.

    Product
    MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1964-2018·2018-06-06

    Arrow Maximal Barrier Drape Recalled for Potential Sterility Compromise

    Arrow International Inc is recalling Maximal Barrier Drapes because unsealed packaging may compromise product sterility. The recall affects 416,055 units distributed in the US and 34 other countries.

    Product
    Maximal Barrier Drape; Product Codes: ASK-00002-1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·042-2018·2018-05-31

    Ruiz Recalls Frozen Breakfast Burritos Due to Plastic Contamination

    Ruiz Food Products is recalling 12-count frozen breakfast burritos that may contain white, semi-rigid plastic pieces. No adverse reactions have been reported.

    Product
    Ruiz Food Products, Inc. — Ruiz Food Products, Inc. Recalls 12-Count Frozen Breakfast Burritos due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·043-2018·2018-05-31

    Eddy Packing Recalls Smoked Sausage Due to Possible Plastic Contamination

    Eddy Packing Co. is recalling smoked sausage that may contain soft plastic. The company discovered the issue after a customer complaint.

    Product
    Eddy Packing Co., Inc. — Eddy Packing Co., Inc. Recalls Smoked Sausage Product due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0838-2018·2018-05-30

    Lupin Recalls My Way Levonorgestrel Tablets for Lack of Approved NDA

    Lupin Pharmaceuticals is recalling My Way (levonorgestrel) emergency contraception tablets because the 2-pack configuration was marketed without an approved New Drug Application.

    Product
    My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180 85212
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1912-2018·2018-05-30

    Spinal Elements Recalls Omega Lumbar Interbody Fusion Devices

    Spinal Elements is recalling 19 Omega Lumbar Interbody Fusion Devices because they were assembled with components that do not match the labeled lordosis angle.

    Product
    AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at o
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0837-2018·2018-05-30

    Lupin Recalls My Way Emergency Contraception Tablets for Lack of Approval

    Lupin Pharmaceuticals is recalling My Way emergency contraception tablets because the 2-pack configuration was marketed without the required regulatory approval.

    Product
    My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1917-2018·2018-05-30

    Implant Direct Dental Implants Recalled for Incorrect Cap Labeling

    Implant Direct Sybron Manufacturing is recalling 298 dental implants because the vial cap may display an incorrect part number, though the main label is correct.

    Product
    ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Dental implants intended for use in partially and fully edentulous upper and low
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1910-2018·2018-05-30

    Baxter EXACTAMIX Inlets Recalled for Incorrect Over-Labeling

    Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display blank or extended expiration dates.

    Product
    Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1902-2018·2018-05-30

    Smith & Nephew Recalls Genesis II Knee Bushings Due to Labeling Error

    Smith & Nephew is recalling 18 units of Genesis II knee bushings because the left and right sides were incorrectly laser marked.

    Product
    smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activ
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0830-2018·2018-05-30

    Mylan Recalls Prednisolone Sodium Phosphate Orally Disintegrating Tablets

    Mylan Pharmaceuticals Inc. is voluntarily recalling PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets due to CGMP deviations.

    Product
    PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1924-2018·2018-05-30

    Baxter Prismaflex Control Units Recalled for Pump Module Electronics Failure

    Baxter Healthcare is recalling Prismaflex control units to install new firmware that prevents a pump module electronics failure causing the device to become inoperable.

    Product
    Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) the
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1904-2018·2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling 16 units of Legion CR XLPE Articular Inserts because the inner packaging pouch was inadvertently sealed with the outer pouch.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1909-2018·2018-05-30

    Baxter EXACTAMIX Inlets Recalled for Incorrect Over-Labeling

    Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display extended expiration dates.

    Product
    Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1897-2018·2018-05-30

    Madison Polymeric Engineering Recalls Endoscopic Cleaning Kits Due to Microbial Contamination

    Madison Polymeric Engineering is recalling First Step Endoscopic Cleaning Kits due to microbial contamination with Yarrowia lipolytica, which causes an unpleasant odor.

    Product
    First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1900-2018·2018-05-30

    Madison Polymeric Engineering Recalls Draco Enzymatic Deep-Cleaning Pads

    Madison Polymeric Engineering is recalling Draco Enzymatic Deep-Cleaning Pads due to microbial contamination with Yarrowia lipolytica, which causes an unpleasant odor.

    Product
    Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1911-2018·2018-05-30

    Baxter EXACTAMIX Inlets Recalled for Incorrect Labeling

    Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display blank or extended expiration dates.

    Product
    Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1894-2018·2018-05-30

    Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Systems for Seal Defects

    Beckman Coulter is recalling six iChem VELOCITY Automated Urine Chemistry Systems because the Strip Provider Modules were not inspected for correct seal placement and integrity during manufacture.

    Product
    iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine chemi
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1926-2018·2018-05-30

    Baxter Recalls Prismaflex 7.20 US Control Units for Firmware Update

    Baxter Healthcare is recalling 231 Prismaflex 7.20 US control units to install new firmware that prevents a pump module electronics failure.

    Product
    Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) ther
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1922-2018·2018-05-30

    Baxter Recalls Prismaflex Systems for Pump Module Electronics Failure

    Baxter Healthcare is recalling Prismaflex Systems to install new firmware that prevents a pump module electronics failure causing the device to become inoperable.

    Product
    Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) thera
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1908-2018·2018-05-30

    Baxter EXACTAMIX Inlets Recalled for Incorrect Over-Labeling

    Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display extended expiration dates.

    Product
    Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1898-2018·2018-05-30

    Madison Polymeric Engineering Recalls Endoscopic Cleaning Pads Due to Microbial Contamination

    Madison Polymeric Engineering is recalling First Step Endoscopic Cleaning Pads because they exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

    Product
    First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1923-2018·2018-05-30

    Baxter Prismaflex 5.10 US Control Units Recalled for Firmware Update

    Baxter Healthcare is recalling 1,256 Prismaflex 5.10 US control units to install new firmware that prevents a pump module electronics failure.

    Product
    Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) ther
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0829-2018·2018-05-30

    Mylan Recalls Prednisolone Sodium Phosphate Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is voluntarily recalling specific lots of Prednisolone Sodium Phosphate Orally Disintegrating Tablets due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
    Category
    Drug
    Distribution
    1 state