The Recall Desk

Archive

October 2020 recalls

622 recalls were announced in October 2020.

What the numbers show

Critical
84
Severe
123
High
313
Moderate
83
Low
19

Of the 622 recalls this month scored against our rubric, 14% are Critical, 20% are Severe.

Which agencies issued them

501–600 of 622

  • SevereFDA (Drugs)·D-0023-2021·2020-10-07

    Blumen Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk

    4e Brands North America is recalling Blumen Advanced Hand Sanitizer due to manufacturing in a facility associated with methanol contamination.

    Product
    blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4 b) 7.5 fl. oz./221 ml bottle, UPC 8 14266 02362 4 b) 33.8 fl. oz./1L bottle, UPC 8 14266 02369 3, Distributed in USA and Canada By: 4e Brands No
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0028-2021·2020-10-07

    Modesa Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk

    4e Brands North America is recalling Modesa hand sanitizer because it was manufactured in a facility associated with methanol contamination, representing poor manufacturing practices.

    Product
    Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico. UPC 0 32251 49935 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0048-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling non-sterile Velosorb Fast Braided Absorbable Sutures due to a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0015-2021·2020-10-07

    Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling non-sterile Velosorb sutures that could compromise sterile fields and increase infection risk.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" V-20 Taper, Product Number: CV417G, UDI: 20884521149370 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0032-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,268 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. The defect could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" PC-10, Product Number: SV835G, UDI: 20884521149721 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0045-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,253 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. This defect could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" GS-20 CV9975G, UDI: 20884521149585 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V618000·2020-10-07

    Lamborghini Recalls 2020 Aventador SVJ Models for Suspension Bolt Issue

    Lamborghini is recalling 2020 Aventador SVJ Coupe and Roadster vehicles because loose front suspension anchor bolts may cause a loss of vehicle control.

    Product
    LAMBORGHINI — LAMBORGHINI AVENTADOR SVJ ROADSTER, AVENTADOR SVJ COUPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1582-2020·2020-10-07

    Spokane Produce Recalls Refrigerated Nacho Products Due to Salmonella

    Spokane Produce, Inc. is recalling refrigerated nacho products due to potential Salmonella Newport contamination linked to onions from Thomson International, Inc.

    Product
    Item 70173 Nacho Mini, Refrigerated, net wt. 20 OZ, packaged in Plastic Container. Item 81103 Nacho Tray, net wt. 40 OZ, packaged in Plastic Container. Item 81105 Nacho Tray Football, net wt. 56 OZ, packaged in Plastic Container. Item 81107 Nacho Tray Mini, net wt.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0029-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 2,499 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. The defect could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cut, Product Number: SV496, UDI: 20884521184258 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1621-2020·2020-10-07

    Cretors Organic Olive Oil Popcorn Recalled for Potential Glass Contamination

    Eagle Family Foods Group is recalling Cretors Organic Extra Virgin Olive Oil Popcorn because pieces of glass may be present in the product.

    Product
    Cretors Organic Extra Virgin Olive Oil Popcorn, 4.4 oz. bag, UPC 732494001170, 12 retail units per wholesale case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0024-2021·2020-10-07

    Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling non-sterile Velosorb sutures that could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" CV-25 Taper, Product Number: CV3100, UDI: 20884521150901 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0043-2021·2020-10-07

    Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,244 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" KV-15 TaperCutting CV2279, UDI: 20884521151632 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0047-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 7,982 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper CV3110, UDI: 20884521150918 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3032-2020·2020-10-07

    Ameditech Recalls CLIA Waived Rapid Drug Tests for Performance Failures

    Ameditech Inc is recalling various CLIA Waived Rapid Drug Tests because immunoassay enzymes failed performance standards, preventing consistent detection of compounds.

    Product
    CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-SDDT-25 / CLIA Waived" Inc. Single Drug Dipstick Test BUP10, X07-CLIA-SDDT-25 / "CLIA Waived" Inc. Single Drug Dipstick Test BUP10, X07-CLIA-SDDT-13 /"CLIA Waived" Inc. Single Drug Dipstick Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3043-2020·2020-10-07

    Ameditech Recalls QuickTox Drug Screen DipCards Due to Performance Failures

    Ameditech is recalling QuickTox Drug Screen DipCards because immunoassay enzymes failed performance tests, meaning the products may not consistently detect all compounds at labeled levels.

    Product
    QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ Drug Screen Dipcard 11 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+PCP25+BZO300+BAR300+MTD300+OXY100+MDMA500", QT88/ "QuickTox¿ Drug Screen Dipcard 12 Drug Detection: COC300+OPI300+MET500+THC50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0040-2021·2020-10-07

    Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,242 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in lig
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0013-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 3,109 units of non-sterile Velosorb sutures distributed nationwide. The defect poses a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3042-2020·2020-10-07

    Ameditech Recalls ProScreen Drugs of Abuse Tests Due to Performance Failures

    Ameditech is recalling ProScreen Drugs of Abuse Tests because immunoassay enzymes failed performance standards, causing inconsistent detection of compounds.

    Product
    ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3030-2020·2020-10-07

    Ameditech Recalls Alere iScreen Multi Drug Detection Tests

    Ameditech is recalling Alere iScreen Multi Drug Detection tests because they may fail to consistently detect all compounds at labeled levels.

    Product
    Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection:AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS12-DX / "Alere iScreen" Dx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0009-2021·2020-10-07

    Recall of Covidien Endo GIA Universal Loading Units Due to Staple Formation Defect

    FDA is recalling specific Covidien surgical stapler kits because the staples may not form properly, potentially preventing adequate hemostasis during surgery.

    Product
    Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0020-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,264 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-12, Cutting Product Number: CV486, UDI: 20884521150925 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3026-2020·2020-10-07

    Zeus ELISA Parvovirus B19 IgM Test System Recalled for False Positives

    Zeus Scientific is recalling 74 units of the ZEUS ELISA Parvovirus B19 IgM Test System due to false positive results identified during an FDA inspection.

    Product
    ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodies to human Parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human Parvovirus B19.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1622-2020·2020-10-07

    Nature's Promise Organic Lightly Salted Popcorn Recalled for Glass Contamination

    Eagle Family Foods Group LLC is recalling Nature's Promise Organic Lightly Salted Popcorn because pieces of glass may be present in the product.

    Product
    Nature's Promise Organic Lightly Salted Popcorn, 6 oz. bag, UPC 688267142611, 9 retail units per wholesale case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1618-2020·2020-10-07

    365 Organic White Cheddar Popcorn Recalled for Glass Contamination

    Eagle Family Foods Group LLC is recalling 365 Whole Foods Market Organic White Cheddar Popcorn because pieces of glass may be present in the product.

    Product
    365 Whole Foods Market Organic White Cheddar Popcorn, 4 oz. bag, UPC 099482428747, 16 retail units per wholesale case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0026-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling non-sterile Velosorb sutures that could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" V-20 Taper, Product Number: CV416G, UDI: 20884521149363 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0042-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 3,109 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. The defect could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25 CV605, UDI: 20884521152295 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, op
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,267 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. The defect could compromise the sterile field and increase the risk of surgical site infections.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cutting, Product Number: SV496G, UDI: 20884521149691 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but no
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0001-2021·2020-10-07

    Endo GIA Stapler Loading Units Recalled for Staple Formation Defects

    FDA recalls Endo GIA Auto Suture Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.

    Product
    Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3038-2020·2020-10-07

    Ameditech MicroTox Immunoassay Enzymes Recalled for Performance Failures

    Ameditech Inc is recalling MicroTox immunoassay enzymes because they failed to consistently detect compounds at labeled levels.

    Product
    MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.G.", MTPA-6MBAU/ "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.G."
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0003-2021·2020-10-07

    Shatto Milk Company Recalls Ice Cream Sandwiches Due to Undeclared Soy

    Shatto Milk Company is recalling 308 chocolate brownie and vanilla ice cream sandwiches because the cookie portion contains undeclared soy.

    Product
    Shatto Milk Company, Brownie, Chocolate Brownie and Vanilla Ice Cream Sammich, Net Wt. 5 oz, Shatto Milk Company, Osborn, MO
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1604-2020·2020-10-07

    Spokane Produce Recalls Unlabeled Yellow Julienne Onions Due to Salmonella Risk

    Spokane Produce, Inc. is recalling 100 pounds of unlabeled, refrigerated yellow julienne onions due to a potential Salmonella Newport contamination.

    Product
    Item 79260 Onion Yellow Julienne, Refrigerated, net wt. 5 LB, packaged in Sealed Plastic Bag. No label.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0007-2021·2020-10-07

    Devonshire Bake Shop Lemon Italian Cream Cake Recalled for Undeclared Peanuts

    Dianne's Fine Desserts is recalling Devonshire Bake Shop Lemon Italian Cream Cake because it contains undeclared peanuts.

    Product
    Devonshire Bake Shop brand Lemon Italian Cream Cake, 10 , Yellow Cake Filled With Italian Lemon Cream, 12 slices
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-3049-2020·2020-10-07

    Ameditech Recalls First Check 4 Panel Drug Cups Due to Performance Failures

    Ameditech Inc is recalling 537,120 units of First Check 4 Panel Drug Cups because they may fail to consistently detect all compounds at labeled levels.

    Product
    First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3021-2020·2020-10-07

    Encore Medical Recalls Mislabeled Humeral Socket Inserts

    Encore Medical is recalling 15 units of RSP Standard Humeral Socket Inserts due to size labeling discrepancies that could lead to incorrect implantation.

    Product
    RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0033-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,276 units of Velosorb Fast Braided Absorbable Sutures because the product is non-sterile. This condition could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 36" KV-34, TaperCutting Product Number: CV916, UDI: 20884521153032 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0012-2021·2020-10-07

    Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling non-sterile Velosorb sutures that could increase the risk of surgical site infections.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2021·2020-10-07

    Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,248 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" SC-1, Product Number: SV2239, UDI: 20884521151779 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0027-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 3,103 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. This defect could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-21 Taper, Product Number: CV947, UDI: 20884521153056 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0041-2021·2020-10-07

    Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,236 units of non-sterile Velosorb sutures due to risks of surgical site infection and compromised sterile fields.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" PC-11 SV487G, UDI: 10884521149595 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0036-2021·2020-10-07

    Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,272 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. This condition could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-21 Taper CV946, UDI: 20884521151298 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1620-2020·2020-10-07

    365 Everyday Value Organic Salted Popcorn Recalled for Glass

    Eagle Family Foods Group is recalling 365 Everyday Value Organic Classic Salted Popcorn because pieces of glass may be present in the product.

    Product
    365 Everyday Value Organic Classic Salted Popcorn, 6 oz. bag, UPC 099482435332, 10 retail units per wholesale case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0039-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,222 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, which could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-25 CV604, UDI: 20884521152288 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, op
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling non-sterile Velosorb Fast Braided Absorbable Sutures because they may compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 30" P-10 Cutting, Product Number: SV4893, UDI: 20884521151717 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but no
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0038-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,260 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-11 SVP2295, UDI: 20884521177410 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3017-2020·2020-10-07

    Olympus BF-Q180 Bronchovideoscope Recalled for Infection Risk and Regulatory Issues

    Olympus is recalling BF-Q180 bronchovideoscopes because they lack 510(k) clearance and are associated with a higher rate of patient infections.

    Product
    Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0003-2021·2020-10-07

    Endo GIA Stapler Recall Due to Incomplete Staple Formation

    FDA is recalling Endo GIA Auto Suture Universal Articulating Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.

    Product
    Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3037-2020·2020-10-07

    Ameditech MicroScreen Immunoassay Recalled for Inconsistent Detection Performance

    Ameditech Inc is recalling 23,000 MicroScreen immunoassay units because they failed to consistently detect compounds at labeled levels.

    Product
    MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G. "
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0005-2021·2020-10-07

    Endo GIA Auto Suture Universal Loading Unit Recall for Staple Formation Defect

    FDA is recalling Endo GIA Auto Suture Universal Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.

    Product
    Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0006-2021·2020-10-07

    Endo GIA Auto Suture Universal Articulating Loading Unit Recall

    FDA is recalling Endo GIA Auto Suture Universal Articulating Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.

    Product
    Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3019-2020·2020-10-07

    Exactech Recalls Equinoxe Reverse Shoulder Compression Screw Kits

    Exactech is recalling Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kits because they may contain screws of incorrect length.

    Product
    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0022-2021·2020-10-07

    Riverpoint Recalls Non-Sterile Velosorb Fast Braided Absorbable Sutures

    Riverpoint Medical is recalling 1,270 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 VL 18" P-10, Product Number: SV32, UDI: 20884521153117 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3015-2020·2020-10-07

    Stryker IsoAir 2.0 Support Surface Recalled for CPR Connector Defect

    Stryker is recalling 110 IsoAir 2.0 support surfaces because a connector defect may delay CPR during cardiac arrest.

    Product
    Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the patient skin, Model Number: 2941-001-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1555-2020·2020-10-07

    Spokane Produce Recalls Refrigerated Black Bean Salad Kits Due to Salmonella

    Spokane Produce, Inc. is recalling 261 pounds of refrigerated Southwest Black Bean Salad Kits because they may be contaminated with Salmonella Newport.

    Product
    Item 80634 Southwest Black Bean Salad Kit, Refrigerated, net wt. 8.7 LB, packaged in Cardboard Box.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-3024-2020·2020-10-07

    Office Depot Recalls JINYINSHAN KN95 Masks Due to Filtration Failure

    Office Depot is recalling 25,360 JINYINSHAN KN95 masks because test results showed they failed to filter more than 95% of particulates.

    Product
    JINYINSHAN, KN95 PROTECTIVE MASK P1, 20 pieces
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0016-2021·2020-10-07

    Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 3,110 units of non-sterile Velosorb sutures because they may compromise the sterile field and increase infection risk.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting, Product Number: SV6830, UDI: 20884521152349 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0014-2021·2020-10-07

    Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling non-sterile Velosorb sutures that could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3020-2020·2020-10-07

    Exactech Recalls Equinoxe Reverse Shoulder Compression Screw Kits

    Exactech is recalling Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kits because they may contain screws of incorrect length.

    Product
    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0028-2021·2020-10-07

    Riverpoint Recalls Non-Sterile Velosorb Fast Braided Absorbable Sutures

    Riverpoint Medical is recalling 1,248 units of non-sterile Velosorb sutures due to a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" CV-23 Taper, Product Number: CV1213, UDI: 20884521150758 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3046-2020·2020-10-07

    Ameditech Recalls First Check 1 Panel Drug Cup Due to Performance Failures

    Ameditech Inc is recalling First Check 1 Panel Drug Cup (THC) units because immunoassay enzymes failed performance tests, preventing consistent detection of compounds.

    Product
    First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0018-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 8,598 units of non-sterile Velosorb sutures because use could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper, Product Number: CV3110, UDI: 20884521150918 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1599-2020·2020-10-07

    Spokane Produce Recalls Sliced Onions Due to Salmonella Newport Risk

    Spokane Produce, Inc. is recalling sliced red onions because they may be contaminated with Salmonella Newport. The product was distributed in Idaho, Montana, Oregon, Washington, and Wyoming.

    Product
    Item 78750 Onion Red Sliced, Refrigerated, net wt. 5 LB, packaged in Sealed Plastic Bag. No label. Item 78751 Onion Red Sliced, Refrigerated, net wt. 5 LB, packaged in Sealed Plastic Bag. No label. Item 78701 Onion Red Sliced Tray, Refrigerated, net wt. 5 LB, packaged
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0011-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling non-sterile Velosorb sutures because their use could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21002·2020-10-07

    Prestone Recalls Antifreeze for Child-Resistant Packaging Defects

    Prestone is recalling about 687,000 antifreeze bottles because their caps may not engage the child-resistant mechanism, posing a poisoning risk to young children.

    Product
    Antifreeze products
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V620000·2020-10-07

    Lance Travel Trailers Recalled for Propane Stove Gas Leak Fire Risk

    Lance Camper is recalling certain 2018-2021 travel trailers with Dometic propane stoves that may develop gas leaks, increasing fire risk. No injuries have been reported.

    Product
    LANCE — LANCE TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V619000·2020-10-07

    2018-2021 Lance Travel Trailers recalled for propane stove gas leak

    Certain 2018-2021 Lance travel trailers are being recalled due to potential gas leaks in Dometic propane stoves that increase fire risk. Free repairs are available.

    Product
    LANCE — LANCE TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0002-2021·2020-10-07

    Endo GIA Stapler Loading Units Recalled for Staple Formation Defects

    FDA recalls Endo GIA Auto Suture Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.

    Product
    Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0002-2021·2020-10-07

    Shatto Milk Company Recalls Ice Cream Sandwiches for Undeclared Soy Allergen

    Shatto Milk Company is recalling Choc + Chip ice cream sandwiches because the cookie portion contains undeclared soy lecithin, a major food allergen.

    Product
    Shatto Milk Company, Choc + Chip, Chocolate Chip Cookie and Vanilla Ice Cream Sammich, Net Wt. 4.5 oz, Shatto Milk Company, Osborn, MO
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0019-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,886 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. The defect could compromise the sterile field and increase the risk of surgical site infections.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-11, Product Number: SVP2294, UDI: 20884521177403 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0046-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 7,496 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0010-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 7,969 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3036-2020·2020-10-07

    Ameditech Recalls ImmuTest Drugs of Abuse Cups for Performance Failures

    Ameditech is recalling ImmuTest Drugs of Abuse Cups because they failed to consistently detect all compounds at labeled levels.

    Product
    ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC50 With Cr, Ni, pH, Bl, S.G.", IMC-8BBCE/ "ImmuTest Drugs of Abuse Cup 8 Drug Detection: (COC300/THC50)+AMP1000+BZO300+BUP10+MET5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0001-2021·2020-10-07

    Good & Gather Organic Kettle Corn Recalled for Possible Glass Fragments

    Shearer's Snacks is recalling 563 cases of Good & Gather Organic Kettle Corn due to a possible risk of glass fragments. Consumers should stop eating the product.

    Product
    Good & Gather Organic Kettle Corn, 7oz pkgs, film bags, 12 individual items per case.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0017-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,258 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-24, Product Number: SV9911G, UDI: 20884521149776 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3018-2020·2020-10-07

    North American Rescue Recalls Emergency Trauma Dressings Due to Sterility Concerns

    North American Rescue LLC is recalling 4 In. Flat Responder Emergency Trauma Dressings because they may lack sterility assurance. The affected dressings are packaged in various first aid and trauma kits.

    Product
    4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit; Kit Product Code: 80-0890 b) M-FAK Mini First Aid Kit, with Bleeding Control Dressing; Kit Product Code: 80-0891 c) M-FAK Mini First Aid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3022-2020·2020-10-07

    Encore Medical Recalls Humeral Socket Inserts Due to Size Mismatch

    Encore Medical is recalling 37 humeral socket inserts because the size etched on the product may differ from the size on the patient sticker label.

    Product
    RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Drugs)·D-1626-2020·2020-10-07

    Legacy Pharmaceutical Recalls Metformin Tablets Due to Foreign Imprint

    Legacy Pharmaceutical Packaging LLC is recalling 111,948 bottles of Metformin Hydrochloride 1000 mg tablets because tablets with different imprints were found in the bottles.

    Product
    Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, Distributed by: Wal-Mart, Bentonville, AR 72716. NDC 68645
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-3027-2020·2020-10-07

    Greiner Bio-One Recalls VACUETTE Blood Collection Tubes Due to Separation Issues

    Greiner Bio-One is recalling VACUETTE blood collection tubes because they experienced an issue with separation and clotting.

    Product
    VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical laboratory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3048-2020·2020-10-07

    Ameditech Recalls First Check 2 Panel Drug Cups Due to Performance Failures

    Ameditech is recalling 41,340 units of First Check 2 Panel Drug Cups because the products failed to consistently detect compounds at labeled levels.

    Product
    First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3050-2020·2020-10-07

    Ameditech Recalls First Check 7 Panel Drug Cups Due to Performance Failures

    Ameditech is recalling 99,900 units of First Check 7 Panel Drug Cups because the products failed to consistently detect all compounds at labeled levels.

    Product
    First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0032-2021·2020-10-07

    Hale & Hearty Wild Mushroom Barley Soup Recalled for Maggots

    Hale And Hearty Soups, LLC is recalling 174 bags of Wild Mushroom Barley soup because the product may contain pieces of maggots.

    Product
    WILD MUSHROOM BARLEY soup; Manufactured By: Hale & Hearty Soups; 2x9.6lbs; 13.8 net weight; Keep Refrigerated
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-3028-2020·2020-10-07

    Beckman Coulter Recalls UIBC Reagent Lot 2690 Due to Erroneous Results

    Beckman Coulter is recalling 219 units of UIBC reagent lot 2690 because it produces erroneously high patient results at the low end of the linear range.

    Product
    UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quantitative determination of Unsaturated Iron Binding Capacity (UIBC) in human serum and plasma on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3051-2020·2020-10-07

    Ameditech Drug Screening Components Recalled for Performance Failures

    Ameditech Inc is recalling specific drug screening components because they failed to consistently detect compounds at labeled levels.

    Product
    Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ EDI PPX Uncut Sheet-Card/ 187877, 160130/ EDI COC Uncut Sheet-Cup/ 188168, 160180/ EDI PCP Uncut Sheet-Cup/ 189027, 160140/ EDI THC Uncut Shee
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1627-2020·2020-10-07

    pH-D Boric Acid Vaginal Suppositories Recalled for Lack of FDA Approval

    pH-D Feminine Health is recalling Boric Acid Vaginal Suppositories because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box, 600 mg each, pH-D Feminine Health, LLC Madison, TN 37115, UPC Code: 3 49597 00044 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3045-2020·2020-10-07

    Ameditech ToxCup Drug Screen Cups Recalled for Performance Failures

    Ameditech is recalling ToxCup Drug Screen Cups because they may fail to consistently detect all substances at labeled levels.

    Product
    ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup¿ Drug Screen Cup COC300/MET500/OPI300/THC50/AMP1000/PCP25/OXY100 Adulteration Screen for CR - NI - PH - BL - S.G.", DT14/ "ToxCup¿ Drug Screen Cup THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3031-2020·2020-10-07

    Ameditech Recalls Alere iCup Drug Detection Cups Due to Performance Failures

    Ameditech Inc is recalling Alere iCup Drug Detection cups because immunoassay enzymes failed performance tests, preventing consistent detection of compounds.

    Product
    Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup¿ Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC Bl, Cr, Ni, pH, SG", I-DXA-13B/"Alere" iCup¿ DX Drug Screen Cup 13 Drug Detection + Adulteration AMP/BAR/BZO/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3054-2020·2020-10-07

    Medline Triage BNP Calibrator Recalled for Improper Refrigeration

    Medline Industries is recalling 118 units of Triage BNP calibrators shipped with ice instead of dry ice, risking product degradation.

    Product
    Control, Calibrator Verified, Triage BNP, Model ALR88755
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-3035-2020·2020-10-07

    Ameditech Recalls One Step + DOA Cup Due to Performance Failures

    Ameditech is recalling 31,800 units of the Henry Schein One Step + DOA Cup because the immunoassay enzymes failed performance tests, resulting in inconsistent detection of compounds.

    Product
    Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3033-2020·2020-10-07

    Ameditech Recalls Consult Diagnostics Drugs Abuse Test Cups

    Ameditech Inc is recalling 31,600 units of Consult Diagnostics Drugs Abuse Test Cups because immunoassay enzymes failed performance tests, leading to inconsistent detection of compounds.

    Product
    Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14 /"Consult Diagnostics DRUGS OF ABUSE TEST CUP 14-DRUG PANEL WITH ADULTERANTS AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3016-2020·2020-10-07

    Cardinal Health Pre-Op Decolonization Kit Recall for Missing Nasal Swabs

    Cardinal Health is recalling pre-operative decolonization kits that contain only one nasal swab instead of the four required for proper treatment.

    Product
    KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3025-2020·2020-10-07

    Siemens CT Software Recall for Workflow Interruptions and Diagnostic Delays

    Siemens Medical Solutions is recalling syngo.CT software versions VB20 and VB20_SP1 for 767 CT systems due to sporadic workflow interruptions that may delay diagnosis or require patient rescans.

    Product
    Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confiden
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3029-2020·2020-10-07

    Ameditech Recalls Alere iScreen Single Drug Detection Dip Cards

    Ameditech is recalling Alere iScreen Single Drug Detection dip cards because they may fail to consistently detect certain compounds at labeled levels.

    Product
    Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Detection: Buprenorphine (BUP)", X11-IS1 BAR-DX /"Alere iScreen" Dx Single Dip Card Single Drug Detection: Barbiturate (BAR)", X11-IS1 OXY-D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3047-2020·2020-10-07

    Ameditech Recalls First Check 14 Panel Drug Cups Due to Performance Failures

    Ameditech is recalling 47,005 units of First Check 14 Panel Drug Cups because immunoassay enzymes failed performance tests, preventing consistent detection of compounds.

    Product
    First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3044-2020·2020-10-07

    Ameditech Recalls TDDA Drugs of Abuse Cups Due to Performance Failures

    Ameditech Inc is recalling TDDA Drugs of Abuse Cups because the immunoassay enzymes failed to consistently detect all compounds at labeled levels.

    Product
    TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G."
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3034-2020·2020-10-07

    Ameditech Fastect II Drug Screen Dipstick Tests Recalled for Performance Failures

    Ameditech is recalling Fastect II Drug Screen Dipstick Tests because they failed to consistently detect compounds at labeled levels.

    Product
    Fastect¿ II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT Description): MF25/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BUP10", QF09/"Fastect¿ II Drug Screen Dipstick Test, 4 Drug Detection: THC50+COC300+OPI300+BZO300", MF20/ "Fas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3040-2020·2020-10-07

    Ameditech iCup Dx14 Drug Screen Cup Recalled for Performance Failures

    Ameditech is recalling iCup Dx14 Drug Screen Cups because immunoassay enzymes failed performance tests, causing inconsistent detection of compounds.

    Product
    iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+ (BAR300/MTD300)+(BUPG10/TCA1000)+(MDMA500/OXY100)+(PCP25/PPX300) 5 Adulteration Tests: Cr, Ni, pH,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0003-2021·2020-10-07

    Teva Recalls Buprenorphine Transdermal Patches for Stability Failures

    Teva Pharmaceuticals USA is recalling Buprenorphine Transdermal Systems because they failed stability specifications for release rate.

    Product
    BUPRENORPHINE — BUPRENORPHINE (BUPRENORPHINE)
    Category
    Drug
    Distribution
    Distributed nationwide

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