The Recall Desk

Archive

December 2019 recalls

567 recalls were announced in December 2019.

What the numbers show

Critical
45
Severe
179
High
165
Moderate
158
Low
20

Of the 567 recalls this month scored against our rubric, 8% are Critical, 32% are Severe.

Which agencies issued them

101–200 of 567

  • ModerateFDA (Devices)·Z-0718-2020·2019-12-25

    Bard Lifestream Vascular Stent Recall Due to Sheath Compatibility Issues

    Bard Peripheral Vascular is recalling 127 Lifestream stents in Australia due to potential difficulty advancing the catheter through a 6F introducer sheath.

    Product
    LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire .035" (0.89mm) RBP 12 atm (1216 kPa) RX Only Lot numbers begins with CMA or CMB. Product Code…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0629-2020·2019-12-25

    Lupin Recalls Memantine Hydrochloride Capsules Due to Dissolution Failure

    Lupin Pharmaceuticals is recalling 3,726 bottles of Memantine Hydrochloride Extended-release Capsules because stability studies showed high out-of-specification dissolution results.

    Product
    MEMANTINE HYDROCHLORIDE — MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0709-2020·2019-12-25

    Angiodynamics Recalls OARTRAC Prostate Balloon Kits Due to Accuracy Issues

    Angiodynamics, Inc. is recalling 160 OARTRAC Prostate Immobilization Endorectal Balloon Device Kits because they may produce readings outside the expected accuracy range.

    Product
    OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0711-2020·2019-12-25

    Angiodynamics Recalls MICRO-PSD Electron Sensors Due to Accuracy Concerns

    Angiodynamics, Inc. is recalling 36 units of MICRO-PSD Electron sensors because they may provide readings outside the expected accuracy range.

    Product
    MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0684-2020·2019-12-25

    Polymer Technology Systems Recalls Walgreens At-Home A1C Test Kits

    Polymer Technology Systems is recalling 15,118 Walgreens At-Home A1C Test Kits due to a software bug that may display incorrect numerical values for extreme results.

    Product
    Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0686-2020·2019-12-25

    CVS Health At Home A1C Test Kit Recalled for Software Bug

    Polymer Technology Systems is recalling CVS Health At Home A1C Test Kits due to a software bug that may display incorrect numerical values for extreme results.

    Product
    CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0703-2020·2019-12-25

    Teleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling

    Teleflex Medical is recalling Sheridan Endobronchial Tubes due to incorrectly labeled tracheal and bronchial swivel connectors.

    Product
    HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0691-2020·2019-12-25

    Integra Recalls Mislabeled Ascension Silicone PIP Joint Implants

    Integra Lifesciences is recalling nine Ascension Silicone PIP implants that were mislabeled as size 1 but contained size 0 implants.

    Product
    Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0713-2020·2019-12-25

    Angiodynamics Recalls Micro-PSD External Beam Photon Sensors

    Angiodynamics, Inc. is recalling 48 Micro-PSD External Beam Photon sensors due to potential accuracy issues. The devices are used to measure radiation therapy during cancer treatment.

    Product
    MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0683-2020·2019-12-25

    Polymer Technology Systems Recalls A1CNow SELF CHECK Software Bug

    Polymer Technology Systems is recalling A1CNow SELF CHECK devices due to a software bug that may display incorrect numerical values instead of expected symbols.

    Product
    A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0692-2020·2019-12-25

    Ameditech Recalls QuickTox 5 Panel Drug Screen DipCard

    Ameditech is recalling QuickTox 5 Panel Drug Screen DipCards due to mixed products. The recall affects 3,400 units distributed in 13 US states.

    Product
    QuickTox 5 Panel Drug Screen DipCard
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0714-2020·2019-12-25

    Alliance Tech Medical Recalls All Flow Pulmonary Function Filters

    Alliance Tech Medical is recalling All Flow Pulmonary Function Filters because patients reported a bad taste associated with the devices.

    Product
    Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a clear, sealed bag printed with the part number, 100 filters/box, for single patient use, latex free, box of 100 Reorder Numbers: 5553100 (single filter reorder no. 5553000)…
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0694-2020·2019-12-25

    Tekia Recalls Mislabeled Hydrophilic Acrylic Intraocular Lenses

    Tekia, Inc. is recalling 36 intraocular lenses that may be mislabeled with the incorrect diopter power. No U.S. distribution occurred.

    Product
    TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0708-2020·2019-12-25

    Rhondium OVC3 One Visit Crown Recalled for Incorrect Expiration Date

    Rhondium Limited is recalling six OVC3 One Visit Crown devices because they were mislabeled with an incorrect expiration date.

    Product
    Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand.
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-0717-2020·2019-12-25

    Boston Scientific Recalls AngioJet Ultra Consoles Missing Operator's Manuals

    Boston Scientific is recalling 169 AngioJet Ultra Consoles because they were shipped without the required Operator's Manual.

    Product
    AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650-007R 105650-009R 105650-024H 105650-024Z 105650-025 105650-025H 105650-025R 105650-026R Product Usage - The AngioJet…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0623-2020·2019-12-25

    Apothecus Recalls VCF Vaginal Contraceptive Foam Due to Canister Leakage

    Apothecus Pharmaceutical Corp. is recalling VCF Vaginal Contraceptive Foam cans and case packs because the canister units exhibit propellant leakage, rendering the product unusable.

    Product
    VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack with 36 cans in a nested container. Net wt 0.6 oz (17g) per can. NDC 52925-312-06, Distributed By: Apothecus Pharmaceutical Corp. Oyster Bay, NY 11771.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0699-2020·2019-12-25

    Allergan Natrelle Breast Implant Recall for Unreadable 2D Barcodes

    Allergan is recalling Natrelle saline-filled breast implants because 2D barcodes may be unreadable by GS-1 scanners due to formatting errors.

    Product
    Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 10888628000513, NATRELLE Style 68LP-150 Saline Round Low 10888628000520, NATRELLE Style 68LP-175 Saline…
    Category
    Medical Device
    Distribution
    47 states
  • LowFDA (Devices)·Z-0700-2020·2019-12-25

    Allergan Recalls Natrelle Breast Implants Due to Unreadable 2D Barcodes

    Allergan is recalling Natrelle silicone breast implants because 2D barcodes may be unreadable by GS-1 scanners due to non-standard formatting.

    Product
    Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod 10888628001206, NATRELLE Style 10-210 Gel Round Mod 10888628001213, NATRELLE Style 10-240 Gel…
    Category
    Medical Device
    Distribution
    47 states
  • LowFDA (Devices)·Z-0702-2020·2019-12-25

    Allergan Recalls Breast Implant Sizers Due to Unreadable Barcodes

    Allergan is recalling NATRELLE Resterilizable Sizers because 2D barcodes may be unreadable by GS-1 scanners due to non-standard formatting.

    Product
    NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L (responsive gel), Inspira ST L (Soft Touch gel), Inspira ST LP (Soft Touch…
    Category
    Medical Device
    Distribution
    47 states
  • LowFDA (Devices)·Z-0701-2020·2019-12-25

    Allergan Recalls Breast Implants With Non-Standard 2D Barcodes

    Allergan is recalling Natrelle Inspira silicone-filled breast implants because 2D barcodes may be unreadable by GS-1 scanners due to formatting errors.

    Product
    Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 7627 SCLP, 7628 SCM, 7629 SCF, 7630 SCX: 7607 SSM/UDI: Natrelle Inspira SSM 140cc BI (US)…
    Category
    Medical Device
    Distribution
    47 states
  • LowFDA (Food)·F-0342-2020·2019-12-25

    Huy Fong Foods Recalls Sriracha Sauce Due to Seal Defects

    Huy Fong Foods is recalling 20,235 cases of Sriracha HOT Chili Sauce because the top seal bulged and exploded when removed.

    Product
    Siracha HOT Chili Sauce Net Wt. 28 oz. (1 lb. 12 oz.) (793 g); Net Wt. 17 oz. (1 Lb. 1 oz.) in PET Plastic bottles UPC: 0 24463 06116 Huy Fong Foods, Inc. 4800 Azusa Rd. Irwindale, CA 91706
    Category
    Food
    Distribution
    12 states
  • SevereNHTSA·19V916000·2019-12-23

    Daimler Trucks Recalls 2020 FCC MT45G Vehicles Due to Fire Risk

    Daimler Trucks North America is recalling 2020 FCC MT45G vehicles because a battery support module can short circuit, increasing the risk of a fire.

    Product
    FCCC — FCCC MT45G
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V917000·2019-12-20

    Peterbilt Recalls 2018-2019 520 Trucks for Steering Bracket Defect

    PACCAR is recalling 2018-2019 Peterbilt 520 trucks because a steering assist bracket may be improperly mounted, risking steering lockup and crashes.

    Product
    PETERBILT — PETERBILT 520
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V918000·2019-12-20

    Mercedes-Benz Recalls Vehicles for Sunroof Glass Detachment Risk

    Mercedes-Benz is recalling 747,928 vehicles from 2001-2011 because the sunroof glass panel may detach, creating a road hazard.

    Product
    MERCEDES BENZ — MERCEDES BENZ, MERCEDES-BENZ C320, E320, CLS500, C280
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V912000·2019-12-20

    BMW Recalls 2019-2020 330i Models Due to Rear Seat Belt Defect

    BMW is recalling 2019-2020 330i and 330i xDrive vehicles because the outboard rear seat belt pretensioners may not lock during a crash, increasing injury risk.

    Product
    BMW — BMW 330I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20046·2019-12-20

    Bosch Recalls Buderus GB125-35 Boilers Due to Carbon Monoxide Hazard

    Bosch Thermotechnology is recalling Buderus GB125-35 oil-condensing boilers because a blocked siphon can cause delayed ignition and carbon monoxide release. No injuries have been reported in the U.S.

    Product
    Buderus GB125-35 oil-condensing boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateNHTSA·19V914000·2019-12-20

    Mercedes-Benz Recalls 2019 GLC Models for Incorrect Air Bag Labels

    Mercedes-Benz is recalling 2019 GLC models because passenger-side sun visors may have air bag warning labels in a foreign language, potentially obscuring safety risks.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GLC63S, AMG GLC43, GLC 300, GLC350E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·122-2019·2019-12-20

    Ashland Sausage Recalls Pork Sausage Due to Possible Plastic Contamination

    Ashland Sausage Company is recalling approximately 1,092 pounds of Berkshire Natural Casing Sausage due to possible contamination with hard, dark plastic.

    Product
    Ashland Sausage Company — Ashland Sausage Co. Recalls Sausage Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    2 states
  • ModerateUSDA FSIS·123-2019·2019-12-20

    Advance Pierre Foods Recalls Frozen Beef Patties Due to Plastic Contamination

    Advance Pierre Foods is recalling approximately 15,739 pounds of frozen, ready-to-eat beef patties that may contain small pieces of green soft plastic.

    Product
    AdvancePierre Foods, Inc. — Advance Pierre Foods Recalls Ready-to-Eat Ground Beef Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V911000·2019-12-19

    PACCAR Recalls 2020 Kenworth and Peterbilt Trucks for Axle Shaft Defect

    PACCAR is recalling 2020 Kenworth and Peterbilt trucks because improperly heat-treated rear axle output shafts may fracture, creating a road hazard.

    Product
    PETERBILT — PETERBILT, KENWORTH 567, 367, W990, 389
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·121-2019·2019-12-19

    Alli & Rose Recalls Salted Egg Fish Skins Due to Import Violation

    Alli & Rose, LLC is recalling approximately 21,930 pounds of Salted Egg Fish Skins because they were imported from Thailand without the required FSIS inspection.

    Product
    Alli & Rose, LLC Recalls Siluriformes Fish Products Produced Without Benefit of Import Inspection
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·19V908000·2019-12-19

    2019 Mercedes-Benz and Freightliner Sprinter Vehicles Recalled for Lashing Rail Defect

    Daimler Vans USA is recalling 2019 Mercedes-Benz and Freightliner Sprinter vans because improperly installed lashing rails may detach, potentially allowing cargo to become unsecured and increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 1500, SPRINTER 2500, SPRINTER 4500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V909000·2019-12-19

    Chrysler Recalls 2020 Jeep Renegade and Fiat 500X for Brake Caliper Defect

    Chrysler is recalling 2020 Jeep Renegade and Fiat 500X vehicles because a fractured right rear brake caliper could fail, reducing braking performance and increasing crash risk.

    Product
    JEEP — JEEP, FIAT RENEGADE, 500X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V910000·2019-12-19

    Subaru Recalls 2016-2017 Outback Vehicles Due to Air Bag Module Issue

    Subaru is recalling 2016-2017 Outback vehicles because a replacement air bag control module may be incompatible, potentially preventing proper passenger air bag deployment.

    Product
    SUBARU — SUBARU OUTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0457-2020·2019-12-18

    Tailor Cut Produce Pineapple Slices Recalled for Salmonella Risk

    Tailor Cut Produce Inc. is recalling pineapple slices due to potential Salmonella contamination. Affected packages have production dates from November 15, 2019, to December 1, 2019.

    Product
    Tailor Cut Produce Inc., Pineapple Slices, 2 - 1 gallon tubs per case.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0221-2020·2019-12-18

    Fresh Creative Foods Recalls Broccoli Salad Kits for Listeria Risk

    Fresh Creative Foods is recalling specific lots of Broccoli Salad Kit V due to potential Listeria monocytogenes contamination. The product was distributed in Oklahoma and Minnesota.

    Product
    Broccoli Salad Kit V 1/4.75 LB Distributed By: Russ Davis Wholesale Wadena, MN 56482 UPC 1345437752
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0220-2020·2019-12-18

    Fresh Creative Foods Recalls Broccoli Cheddar Pasta Salad Kits

    Fresh Creative Foods is recalling Broccoli Cheddar Pasta Salad Kits due to potential Listeria monocytogenes contamination. The product was distributed in Oklahoma and Minnesota.

    Product
    Broccoli Cheddar Pasta Salad Kit V 1/3.7625 LBS Distributed By: Russ Davis Wholesale Wadena, MN 56482 UPC 1345435840 Distributed By: Fresh Creative Foods, Vista CA 92801 2/3.7625 LBS UPC 1812906077
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0455-2020·2019-12-18

    Tailor Cut Produce Recalls Honeydew Balls Due to Salmonella Risk

    Tailor Cut Produce Inc. is recalling Honeydew Balls due to potential Salmonella contamination. Consumers should check production dates and discard affected products.

    Product
    Tailor Cut Produce Inc., Honeydew Balls, 2 - 1 gallon tubs per case.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0458-2020·2019-12-18

    Tailor Cut Produce Recalls Fruit Luau Due to Salmonella Risk

    Tailor Cut Produce Inc. is recalling Fruit Luau tubs because they may be contaminated with Salmonella. Consumers should check production dates and stop using the product.

    Product
    Tailor Cut Produce Inc., Fruit Luau, 2 - 1 gallon tubs per case.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0588-2020·2019-12-18

    Cook CrossCath Support Catheter Recalled for Manufacturing Error

    Cook Inc. is recalling six CrossCath Support Catheters due to a manufacturing error that may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • CriticalFDA (Food)·F-0240-2020·2019-12-18

    Cain Food Industries Recalls Ascorbo 160-2 Powder for Salmonella Risk

    Cain Food Industries is recalling Ascorbo 160-2 Powder due to possible Salmonella contamination. The product was distributed in seven states.

    Product
    Ascorbo 160-2 Powder packaged in 50 lb. Multi-wall paper bag with polyethylene liner
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-0453-2020·2019-12-18

    Tailor Cut Produce Recalls Cantaloupe Chunks Due to Salmonella Risk

    Tailor Cut Produce Inc. is recalling cantaloupe chunks due to potential Salmonella contamination. Consumers should check production dates and discard affected products.

    Product
    Tailor Cut Produce Inc., Cantaloupe Chunks, 2 - 1 gallon tubs per case.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0246-2020·2019-12-18

    Cain Food Industries Recalls Trem 21 Powder for Salmonella Risk

    Cain Food Industries is recalling 4,000 pounds of Trem 21 Powder due to possible Salmonella contamination. The product was distributed in seven states.

    Product
    TREM 21 POWDER packaged in 50 lb. Multi-wall paper bag with polyethylene liner
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-0323-2020·2019-12-18

    Meijer Recalls Vegetable Trays Due to Listeria Monocytogenes Risk

    Meijer Inc. is recalling Fresh From Meijer vegetable trays because they may be contaminated with Listeria Monocytogenes, which can cause serious illness.

    Product
    Fresh From Meijer vegetable tray with UPC 2-20185-00000-2 and PLU 1592, packed in clear plastic sectioned container
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0456-2020·2019-12-18

    Tailor Cut Produce Recalls Pineapple Chunks Due to Salmonella Risk

    Tailor Cut Produce Inc. is recalling Pineapple Chunks because the products have the potential to be contaminated with Salmonella.

    Product
    Tailor Cut Produce Inc., Pineapple Chunks, 2 - 1 gallon tubs per case.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0243-2020·2019-12-18

    Cain Food Industries Recalls OXIBAKE CL Due to Salmonella Risk

    Cain Food Industries is recalling OXIBAKE CL due to possible contamination with Salmonella. The product was distributed in seven states.

    Product
    OXIBAKE CL packaged in 50 lb. Multi-wall paper bag with polyethylene liner
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-0454-2020·2019-12-18

    Tailor Cut Produce Recalls Cantaloupe Balls Due to Salmonella Risk

    Tailor Cut Produce Inc. is recalling cantaloupe balls due to potential Salmonella contamination. Affected packages have production dates from November 15, 2019, to December 1, 2019.

    Product
    Tailor Cut Produce Inc., Cantaloupe Balls, 2 - 1 gallon tubs per case.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0452-2020·2019-12-18

    Tailor Cut Produce Recalls Honeydew Chunk Due to Salmonella Risk

    Tailor Cut Produce Inc. is recalling Honeydew Chunk due to potential Salmonella contamination. Consumers should check production dates and discard affected products.

    Product
    Tailor Cut Produce Inc., Honeydew Chunk, 2 1 gallon tubs per case.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0598-2020·2019-12-18

    Anazao Health Recalls Compounded Clonidine Syringes Due to Fungal Contamination

    Anazao Health is recalling compounded Clonidine, Prialt, and Bupivacaine syringes because environmental sampling detected Talaromyces rotundus, a fungus.

    Product
    Clonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 mg/mL *Compounded 20 mL Syringe (Standard) AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0578-2020·2019-12-18

    Anazao Health Recalls Clonidine and Morphine Sulfate Due to Fungal Contamination

    Coast Quality Pharmacy, LLC dba Anazao Health is recalling Clonidine HCL and Morphine Sulfate products due to the presence of Talaromyces rotundus fungi.

    Product
    Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0610-2020·2019-12-18

    Smiths Medical Medfusion 4000 Syringe Pump Firmware Recall

    Smiths Medical is recalling 626 Medfusion 4000 Syringe Pumps due to a firmware anomaly that may disable battery alarms and interrupt therapy.

    Product
    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0620-2020·2019-12-18

    SCA Pharmaceuticals Recalls Lidocaine Syringes Due to Foreign Material

    SCA Pharmaceuticals is recalling Lidocaine HCl 2% syringes because foreign material was found inside the vials.

    Product
    Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0587-2020·2019-12-18

    Cook CrossCath Support Catheter Recall Due to Manufacturing Error

    Cook Inc. is recalling 20 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Food)·F-0238-2020·2019-12-18

    Cain Food Industries Recalls Vitamin D2 Blend Due to Salmonella Risk

    Cain Food Industries is recalling 2,000 pounds of Vitamin D2 Blend due to possible Salmonella contamination. The product was distributed in seven states.

    Product
    Vitamin D2 Blend packaged in 50 lb. Multi-wall paper bag with polyethylene liner bags
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0590-2020·2019-12-18

    Anazao Health Recalls Hydromorphone, Baclofen, and Clonidine Combination Drugs

    Coast Quality Pharmacy, LLC dba Anazao Health is recalling Hydromorphone HCL, Baclofen, and Clonidine HCL combination drugs due to fungal contamination found during environmental sampling.

    Product
    Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V901000·2019-12-18

    Forest River Recalls 2020 Motorhomes Due to Trailer Hitch Bolt Issue

    Forest River is recalling 2020 Georgetown and FR3 motorhomes because improperly tightened trailer hitch bolts may loosen, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER GEORGETOWN, FR3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0636-2020·2019-12-18

    AuroMedics Recalls Mirtazapine Tablets Due to Labeling Error

    AuroMedics Pharma LLC is recalling Mirtazapine 15 mg tablets because some 500-count bottles are incorrectly labeled as 7.5 mg tablets.

    Product
    MIRTAZAPINE — MIRTAZAPINE (MIRTAZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0589-2020·2019-12-18

    Cook Inc. Recalls CrossCath Support Catheters Due to Manufacturing Error

    Cook Inc. is recalling 43 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0590-2020·2019-12-18

    Cook Inc. Recalls CrossCath Support Catheters Due to Marker Band Fit Issues

    Cook Inc. is recalling 58 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Food)·F-0451-2020·2019-12-18

    Onset Worldwide Recalls Nitro-Milled Black Chia Due to Salmonella

    Onset Worldwide is recalling 50 lb bulk bags of Nitro-Milled Black Chia because the product tested positive for Salmonella.

    Product
    Onset Worldwide, Nitro-Milled Black Chia, Unit size: 50 lb Bulk
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0675-2020·2019-12-18

    Cognision Subject Kit Recalled for Potential B. cepacia Contamination

    Neuronetrix Solutions is recalling 3,108 units of the Cognision Subject Kit (Clinical Grade) due to potential contamination with Burkholderia cepacia.

    Product
    Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - Product Usage: An electroconductive cream for use with external electrodes to reduce the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0599-2020·2019-12-18

    Anazao Health Recalls Compounded Sufentanil Syringes Due to Fungal Contamination

    Coast Quality Pharmacy, LLC dba Anazao Health is recalling compounded sufentanil, clonidine, and bupivacaine syringes because environmental sampling detected Talaromyces rotundus.

    Product
    Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0587-2020·2019-12-18

    Anazao Health Recalls Fentanyl and Morphine Compounded Drugs Due to Fungal Contamination

    Anazao Health is recalling compounded fentanyl and morphine drugs after environmental sampling detected Talaromyces rotundus fungi.

    Product
    Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0335-2020·2019-12-18

    Abundant Foods Kale Broccoli Salad Recalled for Listeria Contamination

    Abundant Foods is voluntarily recalling 67 kits of Good For You Kale Broccoli Salad due to potential Listeria monocytogenes contamination.

    Product
    Abundant Foods Good For You Kale Broccoli Salad, Net Weight: 5.0 lbs., Use Within 6 Days of Pack Date, salad kit packaged in plastic, vacuum-sealed pouch, cases vary by weight; packed by Abundant Foods, 6701 E Stapleton Drive North, Denver, CO 80216. Each kit consists of…
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0326-2020·2019-12-18

    Meijer Broccoli Florets Recalled Due to Listeria Monocytogenes Risk

    Meijer Inc. is recalling Fresh From Meijer Broccoli Florets in six states due to a potential Listeria monocytogenes contamination.

    Product
    Fresh From Meijer Broccoli Florets with UPC 2-21234-00000-4 and PLU 4548, packed in plastic wrapped foam tray or sold from store salad bar
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0616-2020·2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine 300 mg tablets because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    RANITIDINE — RANITIDINE (RANITIDINE)
    Category
    Drug
    Distribution
    0 states
  • SevereUSDA FSIS·120-2019·2019-12-18

    Montpak Recalls Veal and Lamb Products Lacking Import Inspection

    Montpak International Inc. is recalling approximately 4,365 pounds of veal and lamb products that were imported into the U.S. without the benefit of import re-inspection.

    Product
    Montpak International Inc. Recalls Veal and Lamb Products Produced Without Benefit of Import Inspection
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0324-2020·2019-12-18

    Meijer Vegetable Tray Recalled for Listeria Monocytogenes Contamination

    Meijer Inc. is recalling Fresh From Meijer vegetable trays and dip due to Listeria monocytogenes contamination. The affected products were sold in six states.

    Product
    Fresh From Meijer vegetable tray and Dip with UPC 2-20186-00000-1 and PLU 1593, packed in clear plastic sectioned container
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0610-2020·2019-12-18

    Surgery Pharmacy Services Recalls 1,149 Bags of Memorial Central TPN

    Surgery Pharmacy Services is recalling 1,149 bags of Memorial Central TPN due to a lack of sterility assurance. The product was distributed in Georgia and Tennessee.

    Product
    Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Serv., 3908 TENN.AVE., SUITE F., CHATTANOOGA, TN., 37409,
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0614-2020·2019-12-18

    Amneal Recalls Ranitidine Syrup Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Syrup Oral Solution because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0330-2020·2019-12-18

    Breakstones Cottage Cheese Recalled for Potential Plastic and Metal Contamination

    Kraft Heinz is recalling Breakstones 4% Milkfat Small Curd Cottage Cheese due to the potential presence of red plastic and metal pieces introduced during production.

    Product
    Breakstones 4% Milkfat Small Curd Cottage Cheese, in 24 oz. Plastic Tub, with UPC 0 21000 12284 4, 12 packages per case
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0615-2020·2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    RANITIDINE — RANITIDINE (RANITIDINE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0613-2020·2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Tablets 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0602-2020·2019-12-18

    Anazao Health Recalls Baclofen, Clonidine, and Morphine Sulfate Due to Fungal Contamination

    Anazao Health is recalling Baclofen, Clonidine HCL, and Morphine Sulfate products due to the detection of Talaromyces rotundus fungi during environmental sampling.

    Product
    Baclofen and Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0235-2020·2019-12-18

    AC Culinary Group Recalls Chef Pineiro's Ajo con Albahaca Due to Metal Filament

    AC Culinary Group LLC is recalling Chef Pineiro's Ajo con Albahaca in Puerto Rico due to a potential metal filament hazard found in raw materials.

    Product
    Chef Pineiro's Ajo con Albahaca, with Basil, NET WT./PESO NETO 8 oz (233g) and NET WT./PESO NETO 32 oz (907g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0611-2020·2019-12-18

    Surgery Pharmacy Services Recalls Trisodium Citrate CRRT Solution for Sterility Concerns

    Surgery Pharmacy Services is recalling 84 bags of Trisodium Citrate 0.5% CRRT Solution due to a lack of sterility assurance. The product was distributed in Georgia and Tennessee.

    Product
    Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Services,3908 TENN.AVE. CHATT,TN37409
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0608-2020·2019-12-18

    FDA Recalls Anazao Health Hydromorphone, Clonidine, and Fentanyl Combination Drugs

    Anazao Health is recalling specific lots of hydromorphone, clonidine, and fentanyl combination drugs due to fungal contamination found during environmental sampling.

    Product
    Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0617-2020·2019-12-18

    Preferred Pharmaceuticals Recalls Ranitidine Tablets Due to NDMA Impurity

    Preferred Pharmaceuticals is recalling specific lots of Ranitidine Tablets 150 mg because the FDA detected the presence of the NDMA impurity.

    Product
    Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0242-2020·2019-12-18

    Cain Food Industries Recalls CDC-2010 Due to Salmonella Contamination Risk

    Cain Food Industries is recalling 600 pounds of CDC-2010 packaged in 50 lb. bags due to possible Salmonella contamination. The product was distributed in seven states.

    Product
    CDC-2010 packaged in 50 lb. Multi-wall paper bag with polyethylene liner
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0637-2020·2019-12-18

    AuroMedics Recalls Mirtazapine Tablets Due to Labeling Error

    AuroMedics Pharma LLC is recalling Mirtazapine 15 mg tablets that were incorrectly labeled as 7.5 mg. The error affects 500-count bottles distributed nationwide.

    Product
    MIRTAZAPINE — MIRTAZAPINE (MIRTAZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0236-2020·2019-12-18

    Harrison Gypsum Recalls Terra Alba Calcium Sulfate Dihydrate Due to Salmonella Risk

    Harrison Gypsum, LLC is recalling Terra Alba Calcium Sulfate Dihydrate in various bag and bulk sizes due to possible contamination with Salmonella.

    Product
    Terra Alba Calcium Sulfate Dihydrate packaged in 50 lb. bags; 25 lb. bags; 800kg (1764 lb.) bulk bags; 2000 lb. bulk bags; or approximately 45,000- 48,000 lb. bulk pneumatic tanks
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0239-2020·2019-12-18

    Cain Food Industries Recalls ASCORBO 150 Powder for Salmonella Risk

    Cain Food Industries is recalling ASCORBO 150 Powder due to possible Salmonella contamination. The product was distributed in seven states.

    Product
    ASCORBO 150 POWDER packaged in 50 lb. Multi-wall paper bag with polyethylene liner
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0576-2020·2019-12-18

    Jubilant Cadista Recalls Amantadine Hydrochloride Tablets Due to Foreign Object

    Jubilant Cadista Pharmaceuticals is recalling 1,824 bottles of Amantadine Hydrochloride Tablets because a foreign object was found in a single tablet.

    Product
    Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA; NDC 59746-699-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0612-2020·2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·19T024000·2019-12-18

    Cooper Tire Recalls Specific Tires Due to Sidewall Defect

    Cooper Tire is recalling specific Evolution Tour, Mastercraft, Hercules, Starfire, and Stratus tires due to an improper sidewall component that may cause tire deflation and tread separation.

    Product
    TIRES:SIDEWALL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0245-2020·2019-12-18

    Cain Food Industries Recalls SLB-R Powder for Salmonella Contamination

    Cain Food Industries is recalling 2,000 pounds of SLB-R Powder due to possible Salmonella contamination. The product was distributed in seven states.

    Product
    SLB-R POWDER packaged in 50 lb. Multi-wall paper bag with polyethylene liner
    Category
    Food
    Distribution
    7 states

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