The Recall Desk

Archive

November 2019 recalls

944 recalls were announced in November 2019.

What the numbers show

Critical
50
Severe
405
High
251
Moderate
213
Low
25

Of the 944 recalls this month scored against our rubric, 5% are Critical, 43% are Severe.

501–600 of 944

  • 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-0351-2020·2019-11-20

    Smith & Nephew Recalls LAG Screw Guide Pin Sleeves Due to Manufacturing Error

    Smith & Nephew is recalling 116 LAG Screw 3.2mm Guide Pin Sleeves because a manufacturing error prevented the detent balls from fully compressing.

    Product
    LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures; su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0398-2020·2019-11-20

    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 design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0393-2020·2019-11-20

    Orthofix Recalls Prefix II Ankle Kits Due to Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Prefix II Ankle Complete Kits because drill bits have a geometrical defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0362-2020·2019-11-20

    Tec Com TECOTHERM NEO Thermo-Regulation System Recalled for Faulty Peltier Elements

    Tec Com GmbH is recalling five TECOTHERM NEO thermo-regulation systems due to faulty Peltier elements that may fail to maintain temperature control.

    Product
    TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is provi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0380-2020·2019-11-20

    Orthofix Drill Bits Recalled Due to Geometrical Design Defect

    Orthofix Srl is recalling specific lots of 8 mm drill bits because a geometrical detail does not match the intended design, potentially reducing cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0382-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Defect

    Orthofix Srl is recalling specific batches of 3.2 mm drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0349-2020·2019-11-20

    Synthes Trial Spacers Recalled for Modified Manufacturing Process

    Synthes (USA) Products LLC is recalling nine trial spacers with T-handles because they were modified outside of the approved manufacturing process.

    Product
    MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with T-Hand
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0390-2020·2019-11-20

    Orthofix Recalls Prefix II Diaphyseal Complete Kits Due to Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Prefix II Diaphyseal Complete Kits because drill bits have a geometrical defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948
    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 (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 370038694456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-0377-2020·2019-11-20

    Orthofix Drill Bits Recalled Due to Geometric Design Defect

    Orthofix Srl is recalling specific lots of 3.2 mm drill bits because a geometric detail does not match the intended design, potentially reducing cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0364-2020·2019-11-20

    Implant Direct Recalls Dental Implants Due to Packaging Error

    Implant Direct is recalling 23 dental implants because a QA inspection found a healing collar was packaged instead of the implant.

    Product
    Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
    Category
    Medical Device
    Distribution
    5 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-0363-2020·2019-11-20

    Implant Direct Dental Implants Recalled for Potential Packaging Error

    Implant Direct is recalling 53 dental implants because an internal quality inspection found that an incorrect healing collar could have been packaged in the assembly kit.

    Product
    Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0400-2020·2019-11-20

    Orthofix Ankle Sterile Kit Drill Bits Recalled for Design Defect

    Orthofix Srl is recalling specific lots of Ankle Sterile Kits because the drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0399-2020·2019-11-20

    Orthofix Recalls Tibia Femur Diaphyseal Sterile Kits Due to Design Defect

    Orthofix Srl is recalling Tibia Femur 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: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298
    Category
    Medical Device
    Distribution
    29 states
  • 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-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-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
  • 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
  • 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 GLADIATOR, METROSTAR
    Category
    Vehicle
    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
  • 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·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
  • 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
  • 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·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 M, X6
    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·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·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·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
  • 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
  • HighUSDA 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
  • 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
  • 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
  • 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
  • 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·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
  • 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 (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
  • 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-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-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 sellin
    Category
    Food
    Distribution
    8 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 to
    Category
    Food
    Distribution
    8 states
  • 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
  • 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 (Devices)·Z-0277-2020·2019-11-13

    Baxter Prismaflex Control Unit Recalled for Potential Therapy Interruption

    Baxter Healthcare 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-0177-2020·2019-11-13

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

    Dr. Reddy's Laboratories is recalling specific bottles of Ranitidine Tablets 150 mg because an NDMA impurity was detected.

    Product
    Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison) OTC.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0168-2020·2019-11-13

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

    Dr. Reddy's is recalling Ranitidine Hydrochloride capsules because of the presence of the NDMA impurity.

    Product
    RANITIDINE HYDROCHLORIDE — RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • 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 (Drugs)·D-0186-2020·2019-11-13

    Mylan Recalls Alprazolam Tablets Due to Foreign Substance Presence

    Mylan Pharmaceuticals is recalling Alprazolam 0.5 mg tablets because they contain a foreign substance. Consumers should stop using the affected lot and contact their pharmacist.

    Product
    Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0216-2020·2019-11-13

    Red Mountain Compounding Recalls Sterility-Compromised S-E2/Test Cyp Injection

    Red Mountain Compounding Pharmacy is recalling S-E2/Test Cyp 1mg/4mg sesame oil injections due to a lack of assurance of sterility.

    Product
    S-E2/TEST CYP 1MG/4MG SESAME OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0251-2020·2019-11-13

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

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Taurine 50mg/ml vials because the FDA determined there is a lack of assurance of sterility.

    Product
    S-TAURINE 50MG/ML MDV SOLN, Rx only 30ml glass vial, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0289-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-Test Cyp/Prop/Deca-Nan Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Test Cyp/Prop/Deca-Nan 250mg/ml vials because the FDA determined there is a lack of assurance of sterility.

    Product
    S-TEST CYP/PROP/DECA-NAN 250MG/ML (80/10/10) IN SESAME OIL, Rx only, Rx Only, 10ml glass vial. Red Mountain Compounding Rx.
    Category
    Drug
    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-0295-2020·2019-11-13

    Red Mountain Compounding Recalls S-TRIMIX Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-TRIMIX injection vials because the product lacks assurance of sterility.

    Product
    S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vial, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0286-2020·2019-11-13

    Red Mountain Compounding Recalls Testosterone Cypionate Vials Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of Testosterone Cypionate 200mg/mL vials because the FDA identified a lack of assurance of sterility.

    Product
    S-TESTOSTERONE CYP 200MG/ML MDV In SESAME OIL, Rx Only, a) 5ML, b) 10ML, c) 13 ML glass vial, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0207-2020·2019-11-13

    Red Mountain Compounding Recalls Calcium Gluconate Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Calcium Gluconate 10% Injection due to a lack of assurance of sterility.

    Product
    S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass vials, Red Mountain Compounding RX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0264-2020·2019-11-13

    Red Mountain Compounding Recalls S-Folic Acid Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Folic Acid 20mg/mL injection because the product lacks assurance of sterility.

    Product
    S-FOLIC ACID 20MG/ML MDV INJ, packaged in a)10ml b) 30ml, glass vials, Rx Only, 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-0260-2020·2019-11-13

    Red Mountain Compounding Recalls S-DMSO Eye Drops Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-DMSO 6.25% ophthalmic solution because the product lacks assurance of sterility.

    Product
    S-DMSO 6.25% OPTH SOLN, 10 ml dropper bottle, 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-0297-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-TRIMIX Injections for Sterility Concerns

    First Royal Care Co. LLC is recalling S-TRIMIX compounded injections nationwide due to a lack of assurance of sterility.

    Product
    S-TRIMIX various strengths to include:a) S-TRIMIX (15MG/1MG/10MCG/ML) MDV: b) S-TRIMIX (18MG/0.6MG/6MCG/ML) MDV INJ: c) S-TRIMIX (24MG/0.89MG/8.9MCG/ML) MDV INJ: d) S-TRIMIX (28.85MG/1.9MG/19.2MCG/ML) MDV: e) S-TRIMIX (30MG/1MG/10MCG/ML) MDV: f) S-TRIMIX (30MG/2MG/25MCG/ML) MDV:
    Category
    Drug
    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-0283-2020·2019-11-13

    Red Mountain Compounding Recalls S-Test Cyp Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Test Cyp 25mg/ml in sesame oil due to a lack of assurance of sterility.

    Product
    S-TEST CYP 25MG/ML IN SESAME OIL, Rx Only, 5ml glass vial, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0263-2020·2019-11-13

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

    Red Mountain Compounding Pharmacy is recalling S-Estradiol Valerate 40mg/mL injection vials because the product lacks assurance of sterility.

    Product
    S-ESTRADIOL VALERATE 40MG/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-0175-2020·2019-11-13

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

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

    Product
    Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0196-2020·2019-11-13

    Biogenyx CBD Oil Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 25 bottles of Biogenyx CBD Oil because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle, 2400 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0169-2020·2019-11-13

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

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because of the presence of NDMA impurity. The product was distributed to major distributors throughout the United States.

    Product
    Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0255-2020·2019-11-13

    Red Mountain Compounding Recalls S-Vit B Complex Injection for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Vit B Complex Injection vials due to a lack of assurance of sterility. The product was distributed nationwide in the USA.

    Product
    S-VIT B COMPLEX (1/3/5/6/12A) MDV INJ 100/2/2/100/1MG/ML, 30 ML glass vial. Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0294-2020·2019-11-13

    Red Mountain Compounding Recalls S-TRIMIX Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-TRIMIX injection vials because the product lacks assurance of sterility.

    Product
    S-TRIMIX (15MG/0.5MG/16MCG/ML) INJ, Rx Only, 5ML glass vial. Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0345-2020·2019-11-13

    Abiomed lmpella CP Pump Recalled for Incorrect Programming and Disabled Alarms

    Abiomed is recalling one lmpella CP pump with Smart Assist due to incorrect programming that disabled safety alarms and altered pump operation.

    Product
    lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0287-2020·2019-11-13

    Red Mountain Compounding Recalls S-TEST CYP/NAN-DECA Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-TEST CYP/NAN-DECA 200/50MG/ML MDV in sesame oil because the agency could not ensure the product was sterile.

    Product
    S-TEST CYP/NAN-DECA 200/50MG/ML MDV IN SESAME OIL; Rx Only, 10ml glass vial. Red Mountain Compounding Rx
    Category
    Drug
    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

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