The Recall Desk

Archive

November 2020 recalls

382 recalls were announced in November 2020.

What the numbers show

Critical
11
Severe
85
High
183
Moderate
78
Low
25

Of the 382 recalls this month scored against our rubric, 3% are Critical, 22% are Severe.

101–200 of 382

  • HighCPSC·21709·2020-11-19

    Polaris Recalls RZR Recreational Off-Highway Vehicles Due to Clutch Failure Hazard

    Polaris is recalling about 18,400 RZR recreational off-highway vehicles because the clutch can fail, posing an injury hazard. No injuries have been reported.

    Product
    Model Years 2020-2021 RZR PRO XP, PRO XP4 and Model Year 2021 RZR Turbo S, Turbo S4, XP Turbo and XP 4 Turbo ROV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0107-2021·2020-11-18

    Meijer Strawberry and Pineapple Cup Recalled for Salmonella Risk

    Meijer is recalling 1,300 units of Fresh from Meijer Strawberry/Pineapple Cups due to a potential risk of Salmonella. The product was sold in six states.

    Product
    FRESH FROM MEIJER GS STRAWBERRY/PINEAPPLE CUP 6 OZ, 6oz Clear plastic container, UPC 219711302291
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0115-2021·2020-11-18

    Starwest Botanicals Recalls Organic Elderberry Due to Salmonella Risk

    Starwest Botanicals is recalling organic elderberry because a customer test detected Salmonella. The product was distributed nationwide and to two Canadian customers.

    Product
    Elderberry Whole Organic; Sambucus Nigra; Origin: Croatia Distributed in boxes with plastic liners. Various sizes Bulk UPC 7 67963 07314 3, Item # 209290-00 Starwest Botanicals,Inc. 161 Main Street, Sacramento, CA 95838 Certified Organic
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0097-2021·2020-11-18

    Meijer Cantaloupe Chunks Recalled for Potential Salmonella Risk

    Meijer is recalling Fresh from Meijer Cantaloupe Chunks due to a potential risk of Salmonella. The products were sold in six states.

    Product
    FRESH FROM MEIJER CANTALOUPE CHUNKS LARGE BOWL, 32oz Clear plastic container, UPC 219323109721. FRESH FROM MEIJER CANTALOUPE CHUNKS SMALL BOWL, 16oz Clear plastic container, UPC 220196109725. FRESH FROM MEIJER CANTALOUPE CHUNKS KOSHER - LG, 32oz Clear plastic container, UPC 220
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0103-2021·2020-11-18

    Meijer Fruit Tray Recalled for Potential Salmonella Risk

    Meijer is recalling Fresh From Meijer Fruit Trays due to a potential risk of Salmonella. The product was sold in six states between September 26 and October 5.

    Product
    FRESH FROM MEIJER FRUIT TRAY, 49oz Clear plastic container, UPC 219214610008
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0096-2021·2020-11-18

    IncredibleStoneCrab Mustard Sauce Recalled for Undeclared Allergens

    Incredible Fish is recalling 181 containers of IncredibleStoneCrab Mustard Sauce due to undeclared fish, egg, and milk allergens.

    Product
    IncredibleStoneCrab, Mustard Sauce, 8 oz. plastic container, Distributed by: IncredibleStoneCrab,
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0098-2021·2020-11-18

    Meijer Recalls Cantaloupe and Honeydew Slices Due to Salmonella Risk

    Meijer is recalling 24oz containers of Fresh from Meijer Cantaloupe and Honeydew Slices due to a potential risk of Salmonella. The product was sold in six states.

    Product
    FRESH FROM MEIJER CANTALOUPE AND HONEYDEW SLICES, 24oz Clear plastic container, UPC 220219600079
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0102-2021·2020-11-18

    Meijer Fruit Tray With Dip Recalled for Potential Salmonella Risk

    Meijer is recalling Fresh From Meijer Fruit Tray with Dip due to a potential risk of Salmonella. The product was sold in six states.

    Product
    FRESH FROM MEIJER FRUIT TRAY WITH DIP, 49oz Clear plastic container, UPC 219248610449
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0127-2021·2020-11-18

    J&O Mixed Veggie Cup Recalled for Undeclared Egg Allergen

    Russ Davis Wholesale is recalling J&O Mixed Veggie Cups with Dip because they contain undeclared egg. The product was sold in five states.

    Product
    J&O Mixed Veggie Cup with Dip, Net Weight 5.0 oz. (128 g), UPC 95631-85818. Mfg By: RDW, Pueblo CO 81001
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0108-2021·2020-11-18

    Meijer Berry Explosion Cups Recalled for Potential Salmonella Risk

    Meijer is recalling 1,280 units of Fresh from Meijer Berry Explosion Cups due to a potential risk of Salmonella. The products were sold in six states.

    Product
    FRESH FROM MEIJER GS BERRY EXPLOSION CUP 6 OZ, 6oz Clear plastic container, UPC 219717302295
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0104-2021·2020-11-18

    Meijer Fruit Frenzy Bowls Recalled for Potential Salmonella Risk

    Meijer is recalling Fresh From Meijer Fruit Frenzy Bowls due to a potential risk of Salmonella. The recall affects 60,415 units sold in six states.

    Product
    FRESH FROM MEIJER FRUIT FRENZY BOWL LARGE BOWL, 40oz Clear plastic container, UPC 219210112216. FRESH FROM MEIJER FRUIT FRENZY SMALL BOWL, 16oz Clear plastic container, UPC 219601612646. FRESH FROM MEIJER FRUIT FRENZY MEDIUM BOWL, 32oz Clear plastic container, UPC 220200612647.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0099-2021·2020-11-18

    Meijer Triple Treat & Melon Recalled for Potential Salmonella Risk

    Meijer is recalling Fresh from Meijer Triple Treat & Melon due to a potential risk of Salmonella. The product was sold in six states.

    Product
    FRESH FROM MEIJER TRIPLE TREAT & MELON, 22oz Clear plastic container, UPC 220453514736
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·20V713000·2020-11-18

    Lamborghini Recalls 2019-2020 Urus Vehicles Due to Fuel Line Fire Risk

    Lamborghini is recalling 2,831 2019-2020 Urus vehicles because high engine temperatures may damage the fuel line connector, causing a leak and increasing fire risk.

    Product
    LAMBORGHINI — LAMBORGHINI URUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0431-2021·2020-11-18

    Stryker Recalls Cranial Perforators Due to Potential Metal Fragment Risk

    Stryker is recalling Zyphr Disposable Cranial Perforators because a crack in the inner bit could release metal fragments into the surgical site or cause delayed disengagement.

    Product
    Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0425-2021·2020-11-18

    Puritan Bennett 980 Ventilator Recalled for Battery Overheating Risk

    Covidien is recalling Puritan Bennett 980 ventilators due to battery overheating and thermal damage risks that could cause burns or smoke exposure.

    Product
    Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation SKU: 980X1ENDIUU 980X1ENDIUU 980X3FRAIQC 980X3DEDRAC 980X3ENNISB 980X3NLDRAC 980
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0076-2021·2020-11-18

    Baxter Recalls Bupivacaine Injection Due to Particulate Matter

    Baxter Healthcare is recalling specific lots of Bupivacaine Hydrochloride Injection due to the presence of black and transparent particles in the solution.

    Product
    Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0430-2021·2020-11-18

    Stereotaxis Niobe ES System Recalled for Potential Fire Hazard

    Stereotaxis Inc is recalling 121 Niobe ES Systems due to a potential fire risk in the internal computer cabinet.

    Product
    Niobe ES System, Models 001-006000-1 and 001-006100-1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0072-2021·2020-11-18

    H & H Remedies Recalls White Liniment Due to CGMP Deviations

    H & H Remedies, LLC is voluntarily recalling 365 bottles of White Liniment due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    White Liniment packaged in a) 1 oz; b) 4 oz.; and c) 6 oz bottles. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V714000·2020-11-18

    Alfa Romeo Giulia Recall for Rear Brake Disc Fracture Risk

    FCA US LLC is recalling 2020 Alfa Romeo Giulia vehicles because rear brake discs may fracture, potentially reducing braking performance and increasing crash risk.

    Product
    ALFA ROMEO — ALFA ROMEO GIULIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V715000·2020-11-18

    Keystone Outback trailers recalled for potential frame rail buckling defect

    Keystone is recalling 2019–2021 Outback recreational trailers for inadequate frame rail support that may cause buckling and crash risk. Owners should contact 1-866-425-4369 for the free frame reinforcement repair.

    Product
    KEYSTONE — KEYSTONE OUTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0100-2021·2020-11-18

    Meijer Melons and Berries Recalled for Potential Salmonella Risk

    Meijer is recalling Fresh from Meijer Melons & Berries with Dip due to a potential risk of Salmonella. The product was sold in six states.

    Product
    FRESH FROM MEIJER MELONS & BERRIES WITH DIP, 22oz Clear plastic container, UPC 220452914490
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0434-2021·2020-11-18

    Inpeco Aptio Automation System Recall for Potential Sample Dilution

    Inpeco S.A. is recalling 104 Aptio Automation Systems with Aliquoter Modules because a software error may cause samples to be diluted with water, leading to erroneous test results.

    Product
    Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in th
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0101-2021·2020-11-18

    Meijer Recalls Mixed Melon Products Due to Salmonella Risk

    Meijer is recalling specific mixed melon products sold in six states due to a potential risk of Salmonella.

    Product
    FRESH FROM MEIJER MIXED MELON SLICES, 24oz Clear plastic container, UPC 220220600075. FRESH FROM MEIJER MIXED MELON CHUNKS LARGE BOWL, 32oz Clear plastic container, UPC 219334109727. FRESH FROM MEIJER MIXED MELON CHUNKS SMALL BOWL, 16oz Clear plastic container, UPC 219337109724
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0114-2021·2020-11-18

    Starwest Botanicals Recalls Organic Elderberry Tea Due to Salmonella Risk

    Starwest Botanicals is recalling specific lots of organic elderberry tea after a customer test detected Salmonella.

    Product
    Elderberry Whole Organic; Sambucus Nigra; Origin: Croatia 1 lb. and 4 oz. Distributed in Mylar bags. 1 lb. UPC: 7 67963 07315 0; Item # 209290-01 4 oz. UPC 7 67963-10561-5; Item # 209290-04 Daily serving size; Pour 8-12 oz. of boiling water (212 degrees F) over 1 tsp of
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0123-2021·2020-11-18

    B&G Foods Recalls Back to Nature Crackers for Undeclared Peanut

    B&G Foods is recalling Back to Nature Organic Rosemary & Olive Oil Stoneground Wheat Crackers because the package may contain peanut butter cookies, which are not declared on the label.

    Product
    Back to Nature Organic Rosemary & Olive Oil Stoneground Wheat Crackers, NET WT 6 oz (170g)., UPC: 8-19898-01015-8
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·20V716000·2020-11-18

    2021 Volkswagen Atlas and Select Models: Rear Camera Malfunction Risk

    Volkswagen is recalling certain 2021 Atlas and related models because the rear view camera may malfunction during startup, showing a black screen or frozen image, reducing visibility when reversing and increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN ARTEON, GOLF, JETTA, TIGUAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0433-2021·2020-11-18

    Inpeco Accelerator a3600 Aliquoter Module Recall for Sample Dilution Risk

    Inpeco S.A. is recalling 136 Accelerator a3600 Automation Systems with Aliquoter Modules due to a software error that may dilute samples with water, leading to erroneous test results.

    Product
    Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample proc
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0448-2021·2020-11-18

    United Imaging uMI 550 PET/CT System Recalled for Incorrect CT Scan Delay Timer

    Shanghai United Imaging Healthcare is recalling nine uMI 550 PET/CT systems because an incorrect CT scan delay timer may display, potentially exposing operators to unnecessary radiation.

    Product
    Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0106-2021·2020-11-18

    Meijer Fruit Palooza Recalled for Potential Salmonella Risk

    Meijer is recalling Fresh from Meijer Fruit Palooza due to a potential risk of Salmonella. The product was sold in six states.

    Product
    FRESH FROM MEIJER FRUIT PALOOZA, 22oz Clear plastic container, UPC 220450514739
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0432-2021·2020-11-18

    Inpeco FlexLab Automation System Recalled for Potential Sample Dilution

    Inpeco S.A. is recalling 93 FlexLab Automation Systems with Aliquoter Modules because a software error may cause samples to be diluted with water, leading to erroneous test results.

    Product
    FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processin
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0439-2021·2020-11-18

    Fresenius Liberty Select Cycler Software Recall for Inadequate Dialysis Risk

    Fresenius Medical Care is recalling Liberty Select Cycler devices with software version 2.9.0 because a software error may cause the device to fail to recognize extra fluid, potentially leading to inadequate dialysis.

    Product
    Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0095-2021·2020-11-18

    Wolfgang Confectioners Recalls Hu Almond and Cashew Hunks Due to Mislabeling

    Wolfgang Confectioners is recalling Hu Almond Hunks and Hu Cashew Hunks because cashews were found in the almond product pouches.

    Product
    Hu Cashew Hunks, Hu Cashews + Vanilla Bean Chocolate Covered Hunks 4 oz., stand up pouch, 6 bags per case .
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0428-2021·2020-11-18

    Quidel SARS Antigen Test Kits Recalled for False Positive Results

    Quidel is recalling 8,628 SARS Antigen FIA test kits due to false positive results. The affected units were distributed to 24 U.S. states.

    Product
    QUIDEL Sofia SARS Antigen FIA IVD REF 20374
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Food)·F-0094-2021·2020-11-18

    Wolfgang Confectioners Recalls Hu Almond Hunks Due to Undeclared Cashews

    Wolfgang Confectioners is recalling Hu Almond Hunks because cashews were found in the almond product pouches, posing a mislabeling hazard.

    Product
    Hu Almond Hunks, Almonds + Sea Salt Chocolate Covered Hunks 4 oz., stand up pouch, 6 bags per case .
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0110-2021·2020-11-18

    Tropique Fruit Jelly Products Recalled for Choking Hazard

    Commercial Mexicana is recalling Tropique Assorted Fruit Jelly Bags and Jelly Animal Jars due to a choking hazard. The products were sold in New York, New Jersey, Connecticut, Pennsylvania, and Florida.

    Product
    TROPIQUE ASSORTED FRUIT JELLY BAG 30/9PCS/10.06oz and TROPIQUE JELLY ANIMAL JAR 6/26OZ
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0105-2021·2020-11-18

    Meijer Mixed Fruit Cup Recalled for Potential Salmonella Risk

    Meijer is recalling Fresh From Meijer Mixed Fruit Cups due to a potential risk of Salmonella. The product was sold in six states.

    Product
    FRESH FROM MEIJER MIXED FRUIT CUP 6 OZ, 6oz Clear plastic container, UPC 219712601393. FRESH FROM MEIJER MIXED FRUIT CUP, 6oz Clear plastic container, UPC 220124913172. FRESH FROM MEIJER MIXED FRUIT CUP 6 OZ, 6oz Clear plastic container, (GAS STATIONS), UPC 219712601393 PLU 950
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0446-2021·2020-11-18

    United Imaging uCT 550 CT Scanners Recalled for Timer Display Error

    Shanghai United Imaging Healthcare is recalling five uCT 550 CT scanners because an incorrect delay timer display may expose operators to unnecessary radiation.

    Product
    Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (inclu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2021·2020-11-18

    United Imaging uCT 760 CT Scanner Recalled for Timer Display Error

    Shanghai United Imaging Healthcare is recalling five uCT 760 CT scanners because a display error may cause operators to receive unnecessary radiation exposure.

    Product
    Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (inclu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0443-2021·2020-11-18

    Maquet BMU 40 Blood Monitoring Units Recalled for Electrical Safety Non-Compliance

    Maquet Cardiovascular is recalling 51 Blood Monitoring Units (BMU 40) because the printed circuit boards do not meet IEC electrical safety standards for creepage distance.

    Product
    Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: parti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0445-2021·2020-11-18

    United Imaging uCT 530 CT Scanner Recalled for Incorrect Timer Display

    Shanghai United Imaging Healthcare Co., Ltd. is recalling four uCT 530 CT scanners because an incorrect delay timer may display, potentially exposing operators to unnecessary radiation.

    Product
    Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (inclu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0427-2021·2020-11-18

    Boston Scientific AMS 700 MS Pump Recall for Activation Difficulties

    Boston Scientific is recalling AMS 700 MS Pumps due to reports of difficulty activating the device to inflate cylinders.

    Product
    AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0438-2021·2020-11-18

    Merete Medical Recalls OsteoBridge Humerus Nails Due to Mislabeled Product

    Merete Medical GmbH is recalling 144 units of OsteoBridge Intramedullary Diaphysis Segment Fixation nails for the humerus because the product may be mislabeled.

    Product
    OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0073-2021·2020-11-18

    H & H Remedies Recalls Vapor Ointment Due to Manufacturing Deviations

    H & H Remedies, LLC is voluntarily recalling 252 jars of Vapor Ointment due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0070-2021·2020-11-18

    AvKARE Recalls Mesalamine Tablets for Failed Dissolution Specifications

    AvKARE Inc. is recalling specific lots of Mesalamine Delayed-Release Tablets because they failed to meet dissolution specifications.

    Product
    Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0444-2021·2020-11-18

    Aesthetics Biomedical Recalls Vivace Electrosurgical System for Regulatory Violation

    Aesthetics Biomedical is recalling 623 Vivace Electrosurgical Systems because a high-frequency output was not cleared for U.S. distribution.

    Product
    SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0436-2021·2020-11-18

    Merete Medical Recalls OsteoBridge Femoral Nails Due to Labeling Errors

    Merete Medical GmbH is recalling 354 OsteoBridge Intramedullary Diaphysis Segment Fixation nails for the femur because the product may be mislabeled.

    Product
    OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0069-2021·2020-11-18

    Teva Recalls Mesalamine Tablets Due to Failed Dissolution Testing

    Teva Pharmaceuticals is recalling 133,829 bottles of Mesalamine Delayed-Release Tablets because stability testing revealed out-of-specification dissolution results.

    Product
    MESALAMINE — MESALAMINE (MESALAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0071-2021·2020-11-18

    H & H Remedies Recalls Union Salve Due to CGMP Deviations

    H & H Remedies, LLC is voluntarily recalling 939 jars of Union (black) salve due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 16 oz.; and f) 32 oz. jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0437-2021·2020-11-18

    Merete Medical Recalls Tibia Nails Due to Potential Mislabeling

    Merete Medical GmbH is recalling 215 OsteoBridge Intramedullary Diaphysis Segment Fixation nails for the tibia because the product may be mislabeled.

    Product
    OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Food)·F-0109-2021·2020-11-18

    Dole Recalls Coleslaw Products Due to Cleaning Process Deviation

    Dole Fresh Vegetables Inc. is recalling specific lots of Aldi and Kroger coleslaw due to a deviation in the wash process that left some product outside company control.

    Product
    Aldi Little Salad Bar Classis Coleslaw (Green cabbage and carrots), 14 oz. plastic bag UPC:0-414498-30217-7 Kroger brand Coleslaw (Green cabbage and carrots) 16 oz. plastic bag UPC: 0-11110-91040-0
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0426-2021·2020-11-18

    Epitope Diagnostics Recalls COVID-19 IgG ELISA Kits Due to Water Use

    Epitope Diagnostics is recalling 2,886 units of its Novel Coronavirus COVID-19 IgG ELISA Kit because deionized water was used instead of distilled water during manufacturing.

    Product
    EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering ca
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Devices)·Z-0429-2021·2020-11-18

    XTANT Medical Recalls Cervical Implants Due to Incorrect Titanium Grade Labeling

    XTANT Medical is recalling 508 units of cervical implants because the labels incorrectly identify the grade of titanium used in the devices.

    Product
    XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: Ref: X098-0106-STR DI Number: M697X0980106STR1 Mat.: CP Ti Grade 3, Ref: X098-0107-STR DI Numb
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Devices)·Z-0441-2021·2020-11-18

    Hardy Diagnostics Recalls Strep B Carrot Broth Due to Incorrect Expiration Date

    Hardy Diagnostics is recalling Strep B Carrot Broth One-Step units because the outer box displays an incorrect expiration date of 2021-11-10 instead of 2020-11-10.

    Product
    Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
    Category
    Medical Device
    Distribution
    22 states
  • SevereNHTSA·20E085000·2020-11-17

    Denso Recalls Fuel Pumps Due to Impeller Cracking and Engine Stalling Risk

    Denso is recalling fuel pumps where an impeller may crack and deform, causing the pump to fail. This failure can cause the engine to stall while driving, increasing the risk of a crash.

    Product
    FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V712000·2020-11-17

    Volkswagen Atlas Vehicles Recalled for Steering Knuckle Damage

    Volkswagen is recalling certain 2021 Atlas and 2020-2021 Atlas Cross Sport vehicles with damaged steering knuckles that may fail during operation. A failed steering knuckle can cause loss of steering control, increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS, ATLAS CROSS SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V711000·2020-11-17

    Thor Motor Coach Motorhomes Electrical Fire Risk Battery Isolation Recall

    Thor Motor Coach is recalling certain 2020-2021 motorhomes. A faulty Battery Isolation Manager/Relay allows water into the engine compartment, creating electrical arcing and fire risk. Owners should contact TMC at 1-877-855-2867.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH FREEDOM ELITE, DAYBREAK, FOUR WINDS, QUANTUM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V708000·2020-11-17

    Altec Recalls AH150 and AH125 Aerial Devices Due to Valve Defect

    Altec is recalling 2006-2020 AH150 and AH125 aerial devices because an incorrect counterbalance valve may cause the boom to lower unexpectedly, increasing injury risk.

    Product
    ALTEC — ALTEC AH125, AH150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E086000·2020-11-16

    Aries Recalls Tow Hitches Due to Potential Structural Failure

    Aries Industries is recalling certain Class 3 and Class 4 tow hitches because they may not support rated weights, risking hitch failure and vehicle separation.

    Product
    TRAILER HITCHES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V706000·2020-11-16

    2021 Motorhomes Recalled for Bed Lift Motor Failure and Collapse Risk

    REV Recreation Group is recalling certain 2021 motorhomes (Fleetwood and Holiday Rambler models) because the primary gear in the bed lift motor may fail, allowing the bed frame to drop and increase injury risk.

    Product
    HOLIDAY RAMBLER — HOLIDAY RAMBLER, FLEETWOOD NAVIGATOR, NAUTICA, ENDEAVOR, ARMADA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-11152020-01·2020-11-15

    Tucson Tamale Wholesale Recalls Chicken and Pork Tamales Due to Plastic Contamination

    Tucson Tamale Wholesale Company LLC is recalling frozen chicken and pork tamales because they may contain hard plastic from diced tomatoes in puree.

    Product
    Tucson Tamale Wholesale Company LLC — FSIS Issues Public Health Alert for Chicken and Pork Tamales Containing FDA-Regulated Diced Tomatoes in Puree That Have Been Recalled Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V702000·2020-11-13

    2021 Volkswagen Atlas Tires Recalled for Over-Cure Defect

    Volkswagen is recalling certain 2021 Atlas and 2020-2021 Atlas Cross Sport vehicles with potentially over-cured Continental Cross Contact LX Sport tires. Over-cured tires can cause sidewall breaks or tread separation, increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS CROSS SPORT, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V704000·2020-11-13

    Zero Motorcycles Recalls 2020 SR/F and SR/S Models for Brake Switch Defect

    Zero Motorcycles is recalling 2020 SR/F and SR/S motorcycles because water can enter the front brake switch, preventing the brake light from illuminating and increasing crash risk.

    Product
    ZERO — ZERO SR/F, SR/S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V701000·2020-11-13

    Chevrolet Bolt EV Recalled Due to High Voltage Battery Fire Risk

    General Motors is recalling 2017-2019 Chevrolet Bolt EVs because the high voltage battery could catch fire when charged to full capacity, increasing the risk of injury.

    Product
    CHEVROLET — CHEVROLET BOLT EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V703000·2020-11-13

    2021 Winnebago Motorhomes Recalled for Power Bed Motor Failure Risk

    Certain 2021 Winnebago motorhomes are being recalled because the power bed motor may fail internally, causing the bed to extend before the safety strap engages. This can result in the bed falling unexpectedly, posing a risk of injury or death.

    Product
    WINNEBAGO — WINNEBAGO VISTA, ADVENTURER, SUNSTAR, REVEL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V699000·2020-11-12

    Jeep Grand Cherokee Recalled for EGR Cooler Fire Risk

    Chrysler is recalling 2014-2019 Jeep Grand Cherokee vehicles with 3.0L EcoDiesel engines because a cracked EGR cooler may cause an intake manifold fire.

    Product
    JEEP — JEEP GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V700000·2020-11-12

    Fuel tank weld defect may cause fuel leak and fire risk

    BMW and Toyota are recalling certain 2020-2021 Z4 and Supra vehicles due to insufficient fuel tank welds that may cause fuel leaks and increase fire risk. Owners should contact their dealer for a free replacement.

    Product
    TOYOTA — TOYOTA, BMW SUPRA, Z4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V698000·2020-11-12

    2021 Toyota RAV4 Prime headlight aiming caps may improperly adjust

    Certain 2021 Toyota RAV4 Prime vehicles have improperly closed headlight aiming caps that can be adjusted horizontally. This can increase glare and reduce driver visibility, increasing the risk of a crash.

    Product
    TOYOTA — TOYOTA RAV4 PRIME
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21707·2020-11-12

    Zinus Recalls Metal Bunk Beds Due to Fall and Injury Hazards

    Zinus is recalling about 26,000 metal bunk beds because welds on the upper bunk can fail, causing the bed to collapse and posing fall and injury hazards.

    Product
    Zinus metal bunk beds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·PHA-11122020-01·2020-11-12

    Wegmans Beef Culinary Stock Imported Without Required Re-Inspection

    USDA FSIS issued a public health alert for Wegmans Beef Culinary Stock imported without re-inspection. No illnesses have been reported.

    Product
    Wegmans Food Markets — FSIS Issues Public Health Alert for Beef Stock Products Imported Without Benefit of Import Re-Inspection
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0060-2021·2020-11-11

    PD-Rx Recalls Metformin Hydrochloride Extended Release Tablets Due to NDMA

    PD-Rx Pharmaceuticals is recalling 125 bottles of Metformin Hydrochloride Extended Release tablets because of NDMA impurity levels above acceptable limits.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    16 states
  • SevereFDA (Devices)·Z-0326-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cup components because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 47 mm Item Number: 00-8065-544-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0057-2021·2020-11-11

    Denton Pharma Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Denton Pharma, Inc. is recalling specific bottles of Metformin Hydrochloride Extended-Release Tablets 500 mg because they contain N-Nitrosodimethylamine (NDMA) above acceptable levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, N
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0056-2021·2020-11-11

    Denton Pharma Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Denton Pharma, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg due to the detection of N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0330-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cup components because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0061-2021·2020-11-11

    Time-Cap Labs Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Time-Cap Labs, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 500 mg because the FDA detected the impurity N-Nitrosodimethylamine (NDMA) above acceptable intake levels.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0399-2021·2020-11-11

    Cook Inc. Recalls Fixed Core Wire Guides Due to Manufacturing Defects

    Cook Inc. is recalling 61 Fixed Core Wire Guides that may be bent or contain loose foreign matter due to being dropped during manufacturing.

    Product
    Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0373-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cup Components Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 acetabular hip cup components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0372-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0344-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Prosthesis Cups Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 acetabular hip prosthesis cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0346-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0333-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cup Components Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 acetabular hip cup components because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0059-2021·2020-11-11

    PD-Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity

    PD-Rx Pharmaceuticals is recalling 1,683 bottles of Metformin Hydrochloride Extended Release 500 mg because of NDMA impurity levels above acceptable limits.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    16 states
  • SevereFDA (Drugs)·D-0062-2021·2020-11-11

    Metformin Hydrochloride Extended Release Tablets Recalled for NDMA Impurity

    Marksans Pharma Limited is recalling Metformin Hydrochloride Extended Release tablets due to N-Nitrosodimethylamine (NDMA) impurity levels above acceptable intake limits.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0067-2021·2020-11-11

    Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Nostrum Laboratories is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg because the NDMA impurity level exceeds acceptable intake limits.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0068-2021·2020-11-11

    Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Nostrum Laboratories is recalling 20,872 bottles of Metformin Hydrochloride Extended-Release Tablets 500 mg because they contain N-Nitrosodimethylamine (NDMA) above acceptable levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0338-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0345-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 57 mm Item Number: 00-8065-554-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0058-2021·2020-11-11

    Direct Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity

    Direct Rx is recalling 88 bottles of Metformin Hydrochloride Extended Release 500 mg in Florida due to NDMA impurity levels above acceptable intake.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0335-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Cup Hip Prosthesis Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0375-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0343-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0093-2021·2020-11-11

    Spring Glen Fresh Foods Recalls Rice Pudding Due to Undeclared Allergens

    Spring Glen Fresh Foods is recalling 272 containers of Rice Pudding because the product contains undeclared egg and milk due to mis-labeling.

    Product
    Rice Pudding 5lb plastic containers. UPC: 4428421260. Refrigerated 34¿F-38¿F
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0377-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-28
    Category
    Medical Device
    Distribution
    Distributed nationwide

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