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.

20501–20525 of 21633

  • ModerateFDA (Devices)·Z-1278-2013·2013-05-15

    DePuy Mitek Tissue Liberator Recalled for Incorrect Labeling

    DePuy Mitek is recalling 27 Tissue Liberator instruments labeled as Blade Up instead of Blade Down. The mislabeling could lead to incorrect instrument use during surgery.

    Product
    DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1263-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System DIA 5.5 x 100mm Straight Rod due to a raw material issue.

    Product
    Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1231-2013·2013-05-15

    Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1234-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed the wrong pre-vacuum steam sterilization temperature.

    Product
    Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with 30¿ Downward Bend At Proximal End. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1219-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed an incorrect pre-vacuum steam sterilization temperature.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1233-2013·2013-05-15

    Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions

    Stryker Endoscopy is recalling 147,921 irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1260-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Straight Rods

    Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System Straight Rod due to a raw material issue. The affected devices were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1218-2013·2013-05-15

    Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1224-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1259-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System DIA 5.5 x 60mm Straight Rod due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1236-2013·2013-05-15

    Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1261-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of Mercury Spinal System straight rods due to a raw material issue. The affected devices were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1248-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of Mercury Spinal System rods due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1239-2013·2013-05-15

    Smiths Medical Recalls Embryo Replacement Catheters Due to Functional Defect

    Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro and Sure-Pro Ultra Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1216-2013·2013-05-15

    Karl Storz Recalls Photodynamic Diagnosis Instruction Manuals for Safety Updates

    Karl Storz is recalling 15 units of PDD D-Light C System instruction manuals because they contain important safety-related changes.

    Product
    KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1380-2013·2013-05-15

    Winn-Dixie Organic Apple Juice Recalled for Potential Patulin Levels

    Winn-Dixie Logistics is recalling 6,104 bottles of Organic 100% Apple Juice because it may contain patulin levels exceeding FDA limits.

    Product
    Winn Dixie Organic 100% Apple Juice from concentrate with added ingredients, 64-fl oz
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1237-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1232-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling 147,921 irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1235-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1215-2013·2013-05-15

    Becton Dickinson Recalls Gonorrhea Test Kits Due to False Positives

    Becton Dickinson is recalling 77 BD ProbeTec Neisseria gonorrhoeae Qx Amplified DNA Assay Reagent Packs due to increased levels of false positives.

    Product
    BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1262-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of the Mercury Spinal System straight rod due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1221-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1230-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1222-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1220-2013·2013-05-15

    Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions

    Stryker Endoscopy is recalling 147,921 irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide