The Recall Desk

Archive

September 2018 recalls

633 recalls were announced in September 2018.

What the numbers show

Critical
19
Severe
188
High
305
Moderate
102
Low
19

Of the 633 recalls this month scored against our rubric, 3% are Critical, 30% are Severe.

601–633 of 633

  • ModerateFDA (Devices)·Z-2908-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2924-2018·2018-09-05

    Stryker Mako Vizadisc Knee Procedure Tracking Kit Recalled for Detection Issues

    Mako Surgical Corporation is recalling specific lots of the Stryker Mako Vizadisc Knee Procedure Tracking Kit because the reflective material may be damaged, preventing camera detection.

    Product
    Stryker Mako Vizadisc Knee Procedure Tracking Kit
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-2943-2018·2018-09-05

    Bard Midstream Urine Collector Recalled for Iodine Prep Pad Deficiency

    Bard Medical Division is recalling 131,950 urine collection kits because the included iodine prep pads failed to meet required assay levels for their expiration dating.

    Product
    Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drainage funnel, specimen container, funnel lid, specimen lid and a room label.
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Drugs)·D-1170-2018·2018-09-05

    Validus Recalls Calcitriol Oral Solution Due to Subpotency

    Validus Pharmaceuticals is recalling 7,864 bottles of Calcitriol Oral Solution because testing showed lower than expected potency at the 18-month stability time point.

    Product
    Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1907-2018·2018-09-05

    Equate High Performance Protein Shake Chocolate Recalled for Off Odor and Taste

    California Natural Products is recalling two lots of Equate High Performance Protein Shake Chocolate due to reports of off odor and off taste.

    Product
    equate High Performance Protein Shake: Chocolate, Naturally & Artificially Flavored, ready to drink; 11 FL OZ (325 mL), sold in 12 pack case: Case UPC: 6 81131 01580 6 Distributed by: Wal-Mart, Inc. Bentonville, AR
    Category
    Food
    Distribution
    18 states
  • ModerateFDA (Food)·F-1904-2018·2018-09-05

    Ararat Grilled Eggplant and Peppers Recalled for pH Levels

    Artashes LLC is recalling Ararat Grilled Eggplant and Peppers because FDA inspection found pH levels above the scheduled process.

    Product
    Ararat Grilled Eggplant and Peppers 23 oz. glass jar; Ingredients: Eggplants, tomatoes, green pepper, salt. Product of Armenia; Exclusively imported and distributed by: Kradjian Importing Co., Inc. Glendale, CA
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2915-2018·2018-09-05

    Stryker AXS PP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling AXS PP Burr Hole Covers because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2898-2018·2018-09-05

    Stryker QuickFlap Sterile Procedure Pack Recalled for Packaging Compromise

    Stryker is recalling QuickFlap Sterile Procedure Packs because the sterile barrier may become compromised after three years.

    Product
    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy a
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2906-2018·2018-09-05

    Stryker QUIKFLAP Cranial Plates Recalled for Sterile Barrier Compromise

    Stryker is recalling QUIKFLAP cranial plates because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1169-2018·2018-09-05

    Pfizer Recalls Children's Advil Suspension Due to Dosage Cup Labeling Error

    Pfizer is recalling 17,136 bottles of Children's Advil Suspension because the included dosage cup is marked in teaspoons while the label instructions use milliliters.

    Product
    CHILDRENS ADVIL — CHILDRENS ADVIL (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2913-2018·2018-09-05

    Stryker AXS PP Burr Hole Cover Recall for Packaging Compromise

    Stryker is recalling AXS PP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2903-2018·2018-09-05

    Stryker Quikflap Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling Quikflap burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2945-2018·2018-09-05

    Ceterix Disposable Knot Pusher Recalled for High Cut Force

    Ceterix Orthopedics is recalling 96 units of the Disposable Knot Pusher / Suture Cutter because nonconforming blades may require higher than specified cut force.

    Product
    Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2902-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2910-2018·2018-09-05

    Stryker AXS PP Cranium Plates Recalled for Packaging Compromise

    Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.

    Product
    AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Food)·F-1902-2018·2018-09-05

    Ararat Imambayeldy Recalled Due to pH Levels Above Scheduled Process

    Artashes LLC is recalling Ararat Imambayeldy because FDA inspections found pH levels above the scheduled process.

    Product
    Ararat Imambayeldy; 18.3 oz. glass jar; Ingredient: Eggplant, tomato paste, onions, vegetable oil, garlic, green salt Product of Armenia; Exclusively imported and distributed by: Kradjian Importing Co., Inc. Glendale, CA
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2949-2018·2018-09-05

    DePuy P.F.C. SIGMA Revision Knee Distal Augment Recall

    DePuy Orthopaedics is recalling one P.F.C. SIGMA Revision Knee System Distal Augment because it may be missing the screw/collet assembly. The device was not distributed in the United States.

    Product
    P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2901-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2904-2018·2018-09-05

    Stryker QUIKFLAP Cranium Plates Recalled for Sterile Barrier Compromise

    Stryker is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2899-2018·2018-09-05

    Stryker QuickFlap Sterile Procedure Packs Recalled for Packaging Compromise

    Stryker is recalling QuickFlap Sterile Procedure Packs because the sterile barrier may become compromised after three years.

    Product
    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy an
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2909-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2914-2018·2018-09-05

    Stryker AXS PP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling AXS PP burr hole covers because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateNHTSA·18V591000·2018-09-05

    Mitsubishi Outlander Recall for Incorrect Rear Wheel Rim Size Label

    Mitsubishi is recalling 2018-2019 Outlander vehicles with 18-inch alloy wheels because the certification label lists an incorrect rear wheel rim size.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2907-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2957-2018·2018-09-05

    Baxter Recalls FLOSEAL Special Applicator Tips Due to Plastic Formulation Error

    Baxter Healthcare is recalling FLOSEAL Special Applicator Tips because an incorrect plastic formulation was used in the blue luer component.

    Product
    FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are labeled in part, "Floseal SPECIAL APPLICATOR TIPS***Baxter***"."
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1909-2018·2018-09-05

    Morton Natural Sea Salt Recalled for Iodized Salt Packaging Error

    Morton Salt Inc. is recalling 22,284 units of Morton Natural Sea Salt because iodized sea salt was packaged in the wrong containers.

    Product
    MORTON NATURAL SEA SALT ALL PURPOSE***NET WET 26 OZ (1 LB 10 OZ) 737 g***Nutrition Facts***INGREDIENTS: SEA SALT PRODUCT OF BAHAMAS***MORTON SALE, INC, CHICAGO, IL 60606***QUESTIONS? CALL 1-800-789-SALT (7258)
    Category
    Food
    Distribution
    9 states
  • LowFDA (Drugs)·D-1171-2018·2018-09-05

    Validus Recalls Rocaltrol Oral Solution Due to Lower Potency

    Validus Pharmaceuticals is recalling 696 bottles of Rocaltrol (calcitriol) Oral Solution because testing showed lower than expected potency.

    Product
    Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1168-2018·2018-09-05

    Akorn Recalls Azelastine HCl Ophthalmic Solution Due to Impurities

    Akorn, Inc. is recalling specific lots of Azelastine HCl Ophthalmic Solution 0.05% because of out-of-specification results for Azelastine N-oxide.

    Product
    Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1129-2018·2018-09-05

    Mayne Pharma Recalls Oxycodone and Acetaminophen Tablets Due to Labeling Error

    Mayne Pharma is recalling 6,456 bottles of Oxycodone and Acetaminophen Tablets due to a lot number labeling error on the primary container.

    Product
    Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenville, NC 27834, NDC 68308-841-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·074-2018·2018-09-04

    Bahar LLC Recalls Frozen Raw Beef Dumplings Produced Without Inspection

    Bahar LLC is recalling approximately 2,520 pounds of frozen, raw beef dumplings produced without federal inspection. The products were distributed in New Jersey.

    Product
    Bahar, LLC — Bahar LLC Recalls Frozen, Raw Beef Dumpling Products Produced without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·18V587000·2018-09-04

    Midwest Fire Recalls Emergency Vehicles Due to Brake Light Defect

    Midwest Fire is recalling 2017-2019 emergency vehicles because Whelen brake lights may illuminate without the brake pedal being pressed, potentially confusing other drivers.

    Product
    MIDWEST FIRE — MIDWEST FIRE QUICK ATTACK, ALL-POLY SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V584000·2018-09-04

    Collins School Bus Recall for Wheelchair Lift Cam Failure

    Collins Bus is recalling 2012-2018 school buses with Ricon wheelchair lifts because a cam may fail, causing the platform to rise too high and increasing injury risk.

    Product
    COLLINS — COLLINS SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide

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