The Recall Desk

Archive

November 2019 recalls

944 recalls were announced in November 2019.

What the numbers show

Critical
50
Severe
422
High
235
Moderate
212
Low
25

Of the 944 recalls this month scored against our rubric, 5% are Critical, 45% are Severe.

501–600 of 944

  • ModerateFDA (Devices)·Z-0373-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Deviation

    Orthofix Srl is recalling specific drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0383-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometric Design Deviation

    Orthofix Srl is recalling specific lots of 4.8 mm drill bits because a geometric detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Food)·F-0138-2020·2019-11-20

    Relish Foods Recalls Trade Winds Yellowfin Tuna for Histamine Levels

    Relish Foods is recalling 6,000 pounds of Trade Winds Yellowfin Tuna because it tested positive for histamine levels of 140 ppm.

    Product
    Trade Winds Premium Grade Yellowfin (Ahi) Tuna Ground Keep Frozen Net Weight 10 LBS. (4.54 KG) Product of Vietnam Specifically Packed For: Relish Foods, Inc. 5840 Uplander Way #201 Culver City, CA 90230
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0391-2020·2019-11-20

    Orthofix Prefix II Diaphyseal Kit Recalled for Drill Bit Design Defect

    Orthofix is recalling Prefix II Diaphyseal Complete Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0397-2020·2019-11-20

    Orthofix Recalls Lower Limb Diaphyseal Sterile Kits Due to Drill Bit Design

    Orthofix Srl is recalling specific lots of Lower Limb Diaphyseal Sterile Kits because drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0376-2020·2019-11-20

    Orthofix Drill Bits Recalled Due to Geometrical Design Deviation

    Orthofix Srl is recalling specific batches of 4.8 mm drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0385-2020·2019-11-20

    Orthofix Drill Bits Recalled Due to Geometrical Design Defect

    Orthofix Srl is recalling specific lots of drill bits because a geometrical detail does not match the intended design, potentially reducing cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0395-2020·2019-11-20

    Orthofix Pelvis Sterile Kit Recalled for Drill Bit Design Defect

    Orthofix is recalling Pelvis Sterile Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0389-2020·2019-11-20

    Orthofix Recalls UE Xcaliber Ankle Complete Kits Due to Drill Bit Design Flaw

    Orthofix Srl is recalling UE Xcaliber Ankle Complete Kits because drill bits have a design flaw that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0375-2020·2019-11-20

    Orthofix Drill Bits Recalled Due to Geometrical Design Deviation

    Orthofix Srl is recalling specific lots of 4.8 mm drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0358-2020·2019-11-20

    TriMed Peg Guide Extender Recalled Due to Rusting Spring Hazard

    TriMed Inc. is recalling 1,903 Peg Guide Extenders because the spring can rust due to the steel used. The product was distributed nationwide and to several foreign countries.

    Product
    TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Defect

    Orthofix Srl is recalling specific batches of 2.7 mm drill bits because a geometrical detail does not match the intended design, which could result in lower cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0405-2020·2019-11-20

    Tornier Recalls Aequalis Ascend Flex Humeral Stems Due to Packaging Material Transfer

    Tornier, Inc. is recalling 87,869 Aequalis Ascend Flex Humeral Stems because movement during shipping may cause PETG material from the packaging to transfer to the device.

    Product
    Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C 3700386944499 DWF602A 3700386944505 DWF602B 3700386944512 DWF602C 3700386944529 DWF603A 3700386944536 DWF603B 3700386944543 DWF603C 3700386944550 DWF604A…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0384-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Deviation

    Orthofix Srl is recalling specific lots of drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0403-2020·2019-11-20

    Orthofix Galaxy Wrist Sterile Kit Drill Bits Recalled for Design Defect

    Orthofix Srl is recalling Galaxy Wrist Sterile Kits because the drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0378-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Deviation

    Orthofix Srl is recalling specific lots of 4.8 mm drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)18032568031966
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0357-2020·2019-11-20

    TriMed Hex Driver Recall Due to Epoxy Coating Defect

    TriMed Inc. is recalling 467 Hex Drivers because the epoxy coating may pop off. The recall covers units distributed nationwide and to several foreign countries.

    Product
    TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0367-2020·2019-11-20

    Randox NEFA FA115 Recalled for Performance Failure

    Randox Laboratories is recalling NEFA FA115 Lot 485343 because it is not meeting performance claims and should not be used for testing.

    Product
    RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0392-2020·2019-11-20

    Orthofix Recalls Prefix II Diaphyseal Complete Kit Due to Drill Bit Design

    Orthofix Srl is recalling the Prefix II Diaphyseal Complete Kit because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 18033509855962
    Category
    Medical Device
    Distribution
    29 states
  • LowFDA (Drugs)·D-0322-2020·2019-11-20

    Sato Pharmaceutical Recalls Subpotent Zentrip Meclizine Hydrochloride Strips

    Sato Pharmaceutical Inc. is voluntarily recalling Zentrip (meclizine Hydrochloride) 25 mg strips because the medication is subpotent. The recall covers 21,864 units distributed nationwide.

    Product
    Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 49873-803-01. UPC 4987301603
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0323-2020·2019-11-20

    CVS Motion Sickness Tablets Recalled for Subpotent Drug Levels

    Sato Pharmaceutical is recalling CVS Motion Sickness Fast Melting tablets because they may contain less than the labeled amount of meclizine hydrochloride.

    Product
    CVS MOTION SICKNESS FAST MELTING — CVS MOTION SICKNESS FAST MELTING (MECLIZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0325-2020·2019-11-20

    Sato Pharmaceutical Recalls Subpotent Motion Sickness Strips Nationwide

    Sato Pharmaceutical Inc. is recalling 39,504 units of Motion Sickness Strips because the medication may contain less than the labeled amount of meclizine hydrochloride.

    Product
    Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 69842-288-01. UPC 5042849946
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0324-2020·2019-11-20

    Sato Pharmaceutical Recalls Subpotent Wal-Dram 2 Meclizine Hydrochloride Tablets

    Sato Pharmaceutical Inc. is voluntarily recalling specific lots of Wal-Dram 2 Quick-Dissolving tablets because they contain less than the labeled amount of meclizine hydrochloride.

    Product
    WAL-DRAM 2 QUICK-DISSOLVING — WAL-DRAM 2 QUICK-DISSOLVING (MECLIZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V833000·2019-11-19

    Arcimoto Recalls 2019 FUV Motorcycles Due to Inverter Software Defect

    Arcimoto is recalling 2019 FUV motorcycles because an inverter defect may cause unexpected battery shutdowns, increasing crash risk. Dealers will reprogram the inverter software free of charge.

    Product
    ARCIMOTO — ARCIMOTO FUV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V828000·2019-11-19

    Spartan Gladiator and Metrostar Recalled for Brake Control Line Defect

    Marion Body Works is recalling 2005-2020 Spartan Gladiator and Metrostar vehicles because air pressure control lines may not be protected, potentially causing unexpected brake application.

    Product
    SPARTAN — SPARTAN METROSTAR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20024·2019-11-19

    Ontel ISO7X Isometric Exercise Devices Recalled for Projectile Hazard

    United National Closeout Stores is recalling about 1,500 Ontel ISO7X isometric exercise devices because handle grips can break and eject parts, posing an injury risk.

    Product
    ISO7X Isometric Exercise Devices
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V829000·2019-11-19

    Freightliner Econic SD Recalled for Incorrect Axle Weight Rating Labels

    Daimler Trucks North America is recalling 2020 Freightliner Econic SD vehicles because certification labels contain incorrect gross axle weight rating information, which may lead to axle overloading.

    Product
    FREIGHTLINER — FREIGHTLINER ECONIC SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V831000·2019-11-19

    Thomas Built Buses Recalling Saf-T-Liner HDX School Buses for Torque Converter Defect

    Daimler Trucks North America is recalling 2018-2020 Thomas Built Saf-T-Liner HDX school buses because loose torque converter fasteners may disable the vehicle, increasing injury risk during evacuation.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·114-2019·2019-11-19

    BrucePac Recalls Chicken Sausage for Undeclared Pork Casing

    BrucePac is recalling ready-to-eat chicken sausage products because they contain an undeclared pork casing. No adverse reactions have been reported.

    Product
    BrucePac — BrucePac Recalls Ready-to-Eat Chicken Sausage Products Due to Misbranding
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V825000·2019-11-18

    Ducati Recalls 2018 Multistrada 1260 Motorcycles Due to Side Stand Defect

    Ducati is recalling 2018 Multistrada 1260 motorcycles because the side stand may be improperly welded. If the stand breaks, the motorcycle may fall over, increasing injury risk.

    Product
    DUCATI — DUCATI MULTISTRADA 1260
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V820000·2019-11-18

    Mercedes-Benz Recalls 2019 G-Class Vehicles for Door Wiring Defect

    Mercedes-Benz is recalling 2019 G 550 and G63 vehicles because improperly routed front door wiring may damage safety features, increasing crash injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ G 550, G63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V822000·2019-11-18

    Mercedes-Benz Recalls 2019 GLC 300 for Power Steering Defect

    Mercedes-Benz is recalling 2019 GLC 300 vehicles because a failed electrical connection may cause loss of power steering assist, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLC 300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V823000·2019-11-18

    BMW Recalls 2015-2019 X6 Models for Child Seat Anchor Bar Defect

    BMW is recalling 2015-2019 X6 and X6 M vehicles because rear seat lower anchor bars may damage when used with rigid child seat connectors, increasing injury risk in a crash.

    Product
    BMW — BMW X6, X6 M
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V826000·2019-11-18

    Vespa Scooter Recall: Brake Line Defect Increases Crash Risk

    Piaggio is recalling 2019-2020 Vespa scooters because improperly galvanized brake lines may release hydrogen, reducing braking ability and increasing crash risk.

    Product
    VESPA — VESPA GTV 300, GTS 300 HPE, GTS 300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V818000·2019-11-15

    Chrysler Recalls 2015-2018 Ram ProMaster Vehicles Due to Fire Risk

    Chrysler is recalling 2015-2018 Ram ProMaster vans because a seizing engine cooling fan can overheat and cause a fire. Owners should contact dealers for a free replacement.

    Product
    RAM — RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·113-2019·2019-11-15

    Central Valley Meat Recalls Ground Beef Due to Salmonella Dublin

    Central Valley Meat Co. is recalling approximately 34,222 pounds of ground beef products sold in California due to possible Salmonella Dublin contamination.

    Product
    Central Valley Meat Co., Inc. — Central Valley Meat Co., Inc. Recalls Ground Beef Products Due to Possible Salmonella Dublin Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V821000·2019-11-15

    Mercedes-Benz Recalls S560 Models Due to Engine Idler Gear Defect

    Mercedes-Benz is recalling 2018-2019 S560 vehicles because an improperly tightened engine part may detach, causing a stall and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ S560
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19E079000·2019-11-15

    Triumph Recalls Quickshifter Kits for Speed Triple S Motorcycles

    Triumph is recalling aftermarket Quickshifter Kits for Speed Triple S motorcycles because the assembly may interfere with gear changes, increasing crash risk.

    Product
    POWER TRAIN:MANUAL TRANSMISSION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V816000·2019-11-15

    Newmar Recalls 2020 Mountain Aire Motorhomes for Headlight Defect

    Newmar is recalling 2020 Mountain Aire motorhomes because low beam bulbs may fail to illuminate when high beams are activated, increasing crash risk.

    Product
    NEWMAR — NEWMAR MOUNTAIN AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V814000·2019-11-14

    GM Recalls 2019-2020 Silverado and Sierra Trucks for Fire Risk

    General Motors is recalling specific 2019-2020 Chevrolet Silverado and GMC Sierra trucks because hot gas from seat belt pretensioners could ignite the carpet, causing a vehicle fire.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 1500, SILVERADO 2500, SILVERADO 3500, SIERRA 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E077000·2019-11-14

    Chrysler Recalls Ram 1500 Steering Assemblies Due to Short Circuit Risk

    Chrysler is recalling Mopar steering assemblies for Ram 1500 trucks because a contaminated circuit card may short circuit, causing intermittent loss of power steering assist.

    Product
    STEERING:ELECTRIC POWER ASSIST SYSTEM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E078000·2019-11-14

    Ioxus uSTART Battery Support Module Recall for Fire Risk

    Ioxus Corporation is recalling 12V uSTART MD battery support modules because internal short circuits can cause vehicle fires.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V812000·2019-11-14

    2019 Ram 1500 Recalled for Electric Power Steering Defect

    Chrysler is recalling 2019 Ram 1500 trucks because a contaminated electric power steering gear may short circuit, causing intermittent loss of steering assist.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20020·2019-11-14

    Kenmore Elite Microwave Ovens Recalled for Exterior Burn Hazard

    CPSC recalls Kenmore Elite microwave ovens sold at Sears due to incorrect wiring that causes the exterior to overheat, posing a burn risk.

    Product
    Kenmore Elite Microwave Ovens
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0351-2020·2019-11-13

    Green Lumber Natural Fuel For Men capsules recalled for undeclared Tadalafil

    Green Lumber Holdings is recalling Natural Fuel For Men capsules because FDA analysis found undeclared Tadalafil, an approved drug for erectile dysfunction.

    Product
    Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 capsules, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 (949) 426-8622.
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Food)·F-0437-2020·2019-11-13

    Wawona Frozen Berry Products Recalled Due to Hepatitis A Contamination

    Wawona Frozen Foods is recalling specific frozen berry products after FDA sampling detected Hepatitis A. Consumers should check their freezers for the listed items and dates.

    Product
    Season s Choice (Aldi) Berry Medley (Strawberries, Blackberries, Blueberries, Raspberries) (frozen): 16 ounce bags; Item number: 072930-20 Product of Chile. UPC Code:0 41498 31344 9; Wawona Berry Blend (contains Strawberries, Blackberries, Blueberries, Red Raspberries)…
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-0124-2020·2019-11-13

    Jumbo Foods Recalls Tuscan Sun Chicken Salad Sandwiches for Listeria Risk

    Jumbo Foods is recalling Tuscan Sun brand Wedge Chicken Salad sandwiches due to potential Listeria monocytogenes contamination. The product was distributed to stores in eight states.

    Product
    Wedge Chicken Salad, Tuscan Sun brand, is a ready to eat sandwich. Net wt. 9.3 oz (263g). UPC 0 43701 01426 6. Product was distributed frozen or refrigerated (fresh) to stores. Frozen product is not sold directly to consumers and it will be thawed by stores prior selling…
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-0120-2020·2019-11-13

    Tuscan Sun Cranberry Chicken Salad Recalled for Listeria Risk

    Jumbo Foods is recalling Tuscan Sun Cranberry Chicken Salad sandwiches due to potential Listeria monocytogenes contamination. Affected products were distributed in eight states.

    Product
    Cranberry Chicken Salad, Tuscan Sun brand, is a ready to eat sandwich. Net wt. 9.3 oz (263g). UPC 0 43701 01414 3. Product was distributed frozen or refrigerated (fresh) to stores. Frozen product is not sold directly to consumers and it will be thawed by stores prior…
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-0167-2020·2019-11-13

    Teriyaki Grilled Calamari Recalled for Listeria monocytogenes Contamination

    Azuma Foods International is recalling Teriyaki Grilled Calamari due to presumptive positive test results for Listeria monocytogenes.

    Product
    Teriyaki Grilled Calamari, (Grilled Squid with Teriyaki Sauce) Product # 51100; not for retail 10pkg/2.2 lbs. (1kg)/case Distributed by: Azuma Foods International, Inc., USA, Hayward, CA 94545 Product of Thailand
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0436-2020·2019-11-13

    Frozen Raspberries Recalled Due to Hepatitis A Contamination

    Wawona Frozen Foods is recalling frozen raspberries sold at Aldi and Raley's because FDA sampling found Hepatitis A. Consumers should check their bags for specific dates and codes.

    Product
    Season's Choice Raspberries (frozen): 12 ounce bags; Product of Chile. Item number: 076163-01 Aldi brand name Season's Choice UPC Code: 0 41498 12419 9; Raley's Fresh Frozen Red Raspberries: 12 ounce bags; Product of Chile; Item number:072930-20 UPC Code: 46567 00754
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0279-2020·2019-11-13

    Baxter Prismaflex Control Unit Software Recall for Therapy Interruption Risk

    Baxter is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.

    Product
    Prismaflex Control Unit, software versions below 7.21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0174-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 75 mg because of the presence of the NDMA impurity.

    Product
    Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0278-2020·2019-11-13

    Baxter Prismaflex Control Unit Software Recall for Therapy Interruption Risk

    Baxter is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.

    Product
    Prismaflex Control Unit, software versions below 7.21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0216-2020·2019-11-13

    Philips Forte Gamma Camera System Recalled for Falling Detector Hazard

    Philips Medical Systems is recalling 1,167 Forte Gamma Camera Systems because a detector may fall vertically to the end stops of its travel limit.

    Product
    Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0183-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 75 mg because of the presence of the NDMA impurity.

    Product
    Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0172-2020·2019-11-13

    Medtech Rosa Brain 3.0 Neurosurgical Device Recalled for Trajectory Errors

    Medtech SAS is recalling 93 Rosa Brain 3.0 neurosurgical devices because the instrument holder may send tools on incorrect trajectories, potentially leading to improper device placement.

    Product
    Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0276-2020·2019-11-13

    Baxter Prismaflex Control Unit Recalled for Communication Error Alarms

    Baxter Healthcare is recalling Prismaflex Control Units with software versions below 7.21 because communication error alarms may interrupt therapy or cause blood loss.

    Product
    Prismaflex Control Unit, software versions below 7.21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0219-2020·2019-11-13

    Red Mountain Compounding Recalls S-Estradiol Valerate Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Estradiol Valerate 20mg/mL injection vials because the product lacks assurance of sterility.

    Product
    S-ESTRADIOL VALERATE 20MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0214-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-DMSO 100% Sterile Solution

    Red Mountain Compounding Pharmacy is recalling S-DMSO 100% sterile solution vials due to a lack of assurance of sterility.

    Product
    S-DMSO 100% (PF) STERILE SOLUTION; packaged in a) 50 ml and b) 10 ml glass vials, Rx Only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0238-2020·2019-11-13

    Red Mountain Compounding Recalls Magnesium Sulfate Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific vials of Magnesium Sulfate Injection because the FDA determined there is a lack of assurance of sterility.

    Product
    S-MAGNESIUM SULFATE 500MG/ML (4MEQ/ML) MDV INJ SOLN, 30 ML vial, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0215-2020·2019-11-13

    Red Mountain Compounding Recalls S-E2/TEST CYP Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-E2/TEST CYP 0.4MG/1MG/MLMDV IN OIL INJECTION vials due to a lack of assurance of sterility.

    Product
    S-E2/TEST CYP 0.4MG/1MG/MLMDV IN OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0123-2020·2019-11-13

    Jumbo Foods Recalls Tuscan Sun Chipotle Chicken Salad Sandwiches

    Jumbo Foods is recalling Tuscan Sun brand Chipotle Chicken Salad sandwiches due to a potential for contamination with Listeria monocytogenes.

    Product
    Chipotle Chicken Salad, Tuscan Sun brand, is a ready to eat sandwich. Net wt. 9.3 oz (263g). UPC 0 43701 01415 0. Product was distributed frozen or refrigerated (fresh) to stores. Frozen product is not sold directly to consumers and it will be thawed by stores prior…
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0277-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-MIC Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-MIC 25/50/50mg/ml Cyanocobalamin 1mg/ml MDV Solution due to a lack of assurance of sterility.

    Product
    S-MIC 25/50/50MG/ML CYANO 1MG/ML MDV SOLN, RX Only, 30ml glass vial, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0182-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's is recalling Ranitidine Tablets because an NDMA impurity was detected. Consumers should stop using the product and return it to the pharmacy.

    Product
    RANITIDINE — RANITIDINE (RANITIDINE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0009-2020·2019-11-13

    Teleflex Recalls Babi.Plus Pressure Relief Manifolds for Ventilators

    Teleflex is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because the devices vented gas below the stated pressure.

    Product
    Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0257-2020·2019-11-13

    Red Mountain Compounding Recalls Vitamin D3 Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of Vitamin D3 10,000 IU/mL oil injection due to a lack of assurance of sterility.

    Product
    S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0266-2020·2019-11-13

    Red Mountain Compounding Recalls S-HCG/B12A Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-HCG/B12A injection vials due to a lack of assurance of sterility. The recall affects 11 vials distributed nationwide.

    Product
    S-HCG/B12A 1000U/5MG/ML MDV INJ, packaged in a) 5ML b) 10 ML glass vials, Rx Only, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0203-2020·2019-11-13

    Red Mountain Compounding Recalls S-Atropine 0.5% Ophthalmic Solution

    Red Mountain Compounding Pharmacy is recalling S-Atropine 0.5% ophthalmic solution due to a lack of assurance of sterility.

    Product
    S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, Red Mountain Compounding RX.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0177-2020·2019-11-13

    Medtronic Recalls MiniMed Model 500 Remote Controls for Security Vulnerability

    Medtronic is recalling MiniMed Model 500 Remote Controls used with the MiniMed 508 Insulin Pump due to a potential security vulnerability.

    Product
    Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL, MMT-500RNL) for use with the MiniMed 508 Insulin Pump (MMT-508).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0210-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-Dextrose Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Dextrose/Glycerin/Phenol injection vials due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    S-DEXTROSE/GLYCERIN/PHENOL 25/25/2.5% INJ SOLN, 30 ml glass vial, Rx Only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0173-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling CVS brand Ranitidine Tablets 75 mg because of the presence of NDMA impurity.

    Product
    Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80 count bottles (NDC 69842-871-80) c.)160 count bottles (NDC 69842-871-37) (CVS) OTC
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0217-2020·2019-11-13

    Philips Forte Gamma Camera System Recalled Due to Detector Falling Hazard

    Philips Medical Systems is recalling 1,167 Forte Gamma Camera Systems because a detector may fall unimpeded to the end stops of its travel limit.

    Product
    Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0224-2020·2019-11-13

    Red Mountain Compounding Recalls S-Glutathione Vials Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Glutathione 200mg/mL vials due to a lack of assurance of sterility.

    Product
    S-GLUTATHIONE 200MG/ML MDV, packaged in a) 12 ML b) 30 ml, glass vial, Red Mountain Compounding RX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0282-2020·2019-11-13

    Red Mountain Compounding Recalls S-TEST CYP Vials Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-TEST CYP 25mg/ml vials nationwide due to a lack of assurance of sterility.

    Product
    S-TEST CYP 25MG/ML IN ETHYL OLEATE OIL MDV, Rx Only, a)5 ml b) 10 ml c) 13 ml glass vial, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0122-2020·2019-11-13

    Tuscan Sun Bacon Ranch Chicken Salad Recalled Due to Listeria Risk

    Jumbo Foods, Inc. is recalling Tuscan Sun brand Bacon Ranch Chicken Salad sandwiches because they may be contaminated with Listeria monocytogenes.

    Product
    Bacon Ranch Chicken Salad, Tuscan Sun brand, is a ready to eat sandwich. Net wt. 9.3 oz (263g). UPC 0 43701 01417 4. Product was distributed frozen or refrigerated (fresh) to stores. Frozen product is not sold directly to consumers and it will be thawed by stores prior…
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0171-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Walmart-branded Ranitidine Tablets 150 mg because of the presence of the NDMA impurity.

    Product
    Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (NDC 49035-404-65) (Walmart) OTC
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0244-2020·2019-11-13

    Red Mountain Compounding Recalls Potassium Chloride Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of Potassium Chloride Injection because the FDA identified a lack of assurance of sterility.

    Product
    S-POTASSIUM CHLORIDE 2 MEQ/ML INJECTION CONC (PF) 5ml glass vial, Rx Only Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide

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