The Recall Desk

Archive

April 2020 recalls

605 recalls were announced in April 2020.

What the numbers show

Critical
6
Severe
113
High
182
Moderate
294
Low
10

Of the 605 recalls this month scored against our rubric, 1% are Critical, 19% are Severe.

201–300 of 605

  • SevereNHTSA·20V225000·2020-04-21

    Altec Recalls 2017-2020 ST Spray Trucks Due to Electrical Fire Risk

    Altec is recalling 92 ST Spray Trucks from 2017-2020 because an improperly mounted battery fuse holder may cause an electrical short circuit and fire.

    Product
    ALTEC — ALTEC ST SPRAY TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V227000·2020-04-21

    Mercedes-Benz Recalls 2020 AMG GT for eCall Wiring Defect

    Mercedes-Benz is recalling 2020 AMG GT vehicles because a missing wiring ground line may cause the emergency call system to relay inaccurate location data or prevent verbal communication with the call center.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V228000·2020-04-21

    Mercedes-Benz Recalls 2020 E 450 Coupe for Front Seatbelt Webbing Damage

    Mercedes-Benz is recalling 2020 E 450 Coupe vehicles because the front left seatbelt may contact sharp metal components, potentially damaging the webbing and reducing crash protection.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V223000·2020-04-20

    Eldorado CNG Vehicles Recalled for Fuel System Rupture Risk

    Eldorado is recalling 2018-2020 CNG-powered vehicles because the pressure relief device may fail to vent heat, potentially causing the fuel system to rupture.

    Product
    ELDORADO — ELDORADO XHF, E-Z RIDER II, AXESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V222000·2020-04-20

    TransitWorks Recalls Driverge Vans for Seat Belt Retract Issues

    TransitWorks is recalling 2019-2020 Ford Transit and RAM ProMaster vans because seat belt retractors may not secure occupants properly.

    Product
    RAM — RAM, FORD PROMASTER, TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V219000·2020-04-17

    International DuraStar and WorkStar Fuel Heater Fire and Engine Stall Recall

    Navistar is recalling 2017-2020 International DuraStar and WorkStar models, plus IC bus vehicles with Cummins B6.7 engines. The electric fuel heater may overheat and catch fire or cause engine stalling.

    Product
    IC BUS — IC BUS, INTERNATIONAL TC, CE, MV, DURASTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·20733·2020-04-16

    Polaris Recalls 2018-2020 Ranger XP 1000 Off-Road Vehicles Due to Fire Hazard

    Polaris is recalling approximately 80,000 Model Year 2018-2020 Ranger XP 1000 and CREW XP 1000 off-road vehicles because a broken clutch belt can damage the fuel line and cause a fire.

    Product
    Model Year 2018 - 2020 Ranger XP 1000 & CREW XP 1000 Off-Road Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E024000·2020-04-16

    GM Recalls Rugger Liner Tonneau Covers for 2019-2020 Trucks

    General Motors is recalling Rugger Liner hard tri-fold tonneau covers for 2019-2020 Chevrolet Silverado and GMC Sierra 1500 trucks because the attachment system may not secure the cover properly.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20731·2020-04-16

    Dr. Adorable Recalls Sweet Birch Essential Oil for Packaging Defect

    Dr. Adorable is recalling Sweet Birch Essential Oil because the packaging is not child-resistant, posing a risk of poisoning to young children.

    Product
    Dr. Adorable Sweet Birch Essential Oils
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20734·2020-04-16

    Polaris Recalls 2019-2020 Ranger XP 1000 Off-Road Vehicles Due to Fire Hazard

    Polaris is recalling approximately 7,000 Model Year 2019-2020 Ranger XP 1000 and CREW XP 1000 off-road vehicles because a misrouted fuel line poses a fire hazard.

    Product
    Model Year 2019 - 2020 Ranger XP 1000 & CREW XP 1000 Off-Road Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20111·2020-04-16

    Wyndmere Naturals Recalls Essential Oils Due to Non-Child-Resistant Packaging

    Wyndmere Naturals is recalling two essential oil products because they lack child-resistant packaging, posing a poisoning risk to young children.

    Product
    Wyndmere Birch Sweet Essential Oil and Aches and Pains Synergistic Blend
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V217000·2020-04-16

    Ford Recalls 2020 Expedition Vehicles Due to Seatbelt Sensor Defect

    Ford is recalling 2020 Expedition vehicles because a front passenger seatbelt sensor may malfunction, potentially misclassifying the occupant and reducing crash protection.

    Product
    FORD — FORD EXPEDITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20735·2020-04-16

    Polaris Recalls 2019 PRO XD and 2020 Ranger UTVs for Seat Belt Failure

    Polaris is recalling about 10,100 utility vehicles because seat belts may fail during a collision or tip-over, posing an injury hazard.

    Product
    Model Year 2019 Polaris PRO XD and model year 2020 Ranger Utility vehicles (UTVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V218000·2020-04-16

    Subaru Recalls 2019 Models for Fuel Pump Failure Risk

    Subaru is recalling 2019 Impreza, Outback, Legacy, and Ascent vehicles because the low pressure fuel pump may fail, causing the engine to stall.

    Product
    SUBARU — SUBARU IMPREZA, LEGACY, ASCENT, OUTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20110·2020-04-16

    MTD Southwest Recalls Troy-Bilt, Craftsman, and Remington Trimmers and Polesaws

    MTD Southwest is recalling specific Troy-Bilt, Craftsman, and Remington trimmers and polesaws because the heads can continue rotating after the throttle is released, posing a laceration hazard.

    Product
    Troy-Bilt and Craftsman 25cc 2-Cycle trimmers and Remington 25cc 2-Cycle polesaw
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0891-2020·2020-04-15

    Koi Koi Trading Recalls Fresh Salmon Due to Listeria Risk

    Koi Koi Trading is recalling fresh salmon in Southern California because the product may be contaminated with Listeria monocytogenes.

    Product
    Fresh Salmon; Brand names : Bakka, Superior, Scottish Canada, Ocean Quality, Norway. Refrigerate Unit size: 10-12 lbs., 14-16 lbs., 16-18 lbs., 18-20 lbs,; packed in Styrofoam box; 2 pieces, 3 pieces or 4 pieces in the box.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1091-2020·2020-04-15

    PharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues

    PharMEDium Services is recalling 46 lots of ePHEDrine Sulfate syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1083-2020·2020-04-15

    PharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues

    PharMEDium Services is recalling 46 lots of rocuronium bromide syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1087-2020·2020-04-15

    PharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues

    PharMEDium Services, LLC is recalling 46 lots of rocuronium bromide syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1082-2020·2020-04-15

    PharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns

    PharMEDium Services LLC is recalling 46 lots of nICARdipine HCl injection products because of a lack of sterility assurance.

    Product
    nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1099-2020·2020-04-15

    Innovative Compounding Pharmacy Recalls Alprostadil Injection Due to Sterility Concerns

    Innovative Compounding Pharmacy is recalling Alprostadil, Papaverine, and Phentolamine injection due to a lack of assurance of sterility. The product was distributed to patients in California, Maine, and Texas.

    Product
    Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1133-2020·2020-04-15

    Herbal Doctor Remedies Recalls Herpes Off Due to Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Herpes Off because the product is misbranded as an unapproved new drug. The product was sold online in the U.S. and internationally.

    Product
    Herpes Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1092-2020·2020-04-15

    PharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns

    PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products because of a lack of sterility assurance.

    Product
    fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1680-2020·2020-04-15

    Siemens PRIMUS HI Linear Accelerators Recalled for Radiation Overdose Risk

    Siemens is recalling PRIMUS HI linear accelerators because a safety interlock defect could cause a 10-20% overdose of radiation therapy.

    Product
    PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-1677-2020·2020-04-15

    Siemens ARTISTE MV System Recalled for Radiation Dose Monitoring Safety Interlock Defect

    Siemens is recalling ARTISTE MV Systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% radiation therapy overdose.

    Product
    ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Drugs)·D-1100-2020·2020-04-15

    Teva Recalls Losartan Potassium Tablets Due to Impurity Detection

    Teva Pharmaceuticals USA is recalling bulk Losartan Potassium Tablets because an impurity was detected in the active pharmaceutical ingredient.

    Product
    LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1085-2020·2020-04-15

    PharMEDium Recalls Fentanyl Citrate Infusions Due to Sterility Assurance Issues

    PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate infusions because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1629-2020·2020-04-15

    Zeiss Laser Scanning Microscope Component Recalled for Laser Safety Bypass

    Zeiss is recalling a component for LSM 700, 800, and 900 microscopes because tilting the light arm can bypass laser safety, causing Class IIIB laser radiation emission.

    Product
    Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1140-2020·2020-04-15

    Herbal Doctor Remedies Recalls Lipidtrol Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Lipidtrol 500mg capsules because the products were found to be misbranded as unapproved new drugs due to CGMP deviations.

    Product
    Lipidtrol, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1174-2020·2020-04-15

    Herbal Doctor Remedies Recalls Thyro-H Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Thyro-H 500mg capsules because the products were found to be misbranded as unapproved new drugs.

    Product
    Thyro-H, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1102-2020·2020-04-15

    Teva Recalls Losartan Potassium Tablets Due to NMBA Impurity

    Teva Pharmaceuticals USA is recalling bulk Losartan Potassium Tablets 100 mg because an impurity called NMBA was detected in the active ingredient.

    Product
    LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1678-2020·2020-04-15

    Siemens Medical Solutions Recalls MEVATRON Radiation Therapy Systems

    Siemens Medical Solutions is recalling specific MEVATRON radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% radiation overdose.

    Product
    MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Drugs)·D-1101-2020·2020-04-15

    Teva Recalls Losartan Potassium Tablets Due to NMBA Impurity

    Teva Pharmaceuticals USA is recalling bulk Losartan Potassium Tablets 50 mg because an impurity, NMBA, was detected in the active pharmaceutical ingredient.

    Product
    LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1103-2020·2020-04-15

    Avet Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Avet Pharmaceuticals is recalling Losartan Potassium Tablets 50 mg because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., E
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1097-2020·2020-04-15

    Innovative Compounding Pharmacy Recalls Hydroxyprogesterone Caproate Due to Sterility Concerns

    Innovative Compounding Pharmacy is recalling Hydroxyprogesterone Caproate injections because the FDA cannot ensure the product is sterile. Patients in California, Maine, and Texas should stop using the medication.

    Product
    Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1093-2020·2020-04-15

    PharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Issues

    PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products because of a lack of sterility assurance.

    Product
    fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1098-2020·2020-04-15

    Innovative Compounding Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

    Innovative Compounding Pharmacy is recalling Testosterone Cypionate In Sesame Oil 200mg/ml injectable vials because the firm cannot assure the sterility of the product.

    Product
    Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1088-2020·2020-04-15

    PharMEDium Recalls ePHEDrine Sulfate IV Syringes Due to Sterility Concerns

    PharMEDium Services is recalling 375 units of ePHEDrine Sulfate IV syringes because of a lack of sterility assurance.

    Product
    ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1121-2020·2020-04-15

    Dragon Pain Balm Recalled for Being an Unapproved New Drug

    Herbal Doctor Remedies is recalling Dragon Pain Balm because it is misbranded as an unapproved new drug. The product was sold online in the US and internationally.

    Product
    Dragon Pain Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1089-2020·2020-04-15

    PharMEDium Recalls Fentanyl Citrate Injection Lots for Sterility Assurance Issues

    PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products due to a lack of sterility assurance.

    Product
    fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1112-2020·2020-04-15

    FDA Recalls Bleeding Stop for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Bleeding Stop because the product is misbranded as an unapproved new drug. The product was sold online in the US and internationally.

    Product
    Bleeding Stop, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1095-2020·2020-04-15

    Innovative Compounding Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Innovative Compounding Pharmacy is recalling specific lots of Methylcobalamin Injectable due to a lack of assurance of sterility. Patients in California, Maine, and Texas should stop using the product.

    Product
    Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1096-2020·2020-04-15

    Innovative Compounding Pharmacy Recalls MIC-8 Injectable Due to Sterility Concerns

    Innovative Compounding Pharmacy is recalling MIC-8 injectable vials because the firm cannot assure the product's sterility. Patients in California, Maine, and Texas should stop using the product.

    Product
    MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1084-2020·2020-04-15

    PharMEDium Recalls Hydromorphone Syringes Due to Sterility Assurance Issues

    PharMEDium Services is recalling 46 lots of Hydromorphone in 0.9% Sodium Chloride HCl syringes due to a lack of sterility assurance.

    Product
    HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1679-2020·2020-04-15

    Siemens ONCOR Radiation Therapy Systems Recalled for Potential Dose Overdose

    Siemens is recalling specific ONCOR radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% overdose.

    Product
    ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Drugs)·D-1081-2020·2020-04-15

    PharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Concerns

    PharMEDium Services is recalling 46 lots of ePHEDrine Sulfate syringes because the company could not ensure the products were sterile.

    Product
    ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1086-2020·2020-04-15

    PharMEDium Recalls Succinylcholine Chloride Syringes Due to Sterility Assurance Issues

    PharMEDium Services is recalling 46 lots of succinylcholine chloride syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 71019-341-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1090-2020·2020-04-15

    PharMEDium Recalls 46 Lots of IV Products Due to Sterility Concerns

    PharMEDium Services, LLC is recalling 46 lots of various IV products because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0888-2020·2020-04-15

    Amy's Kitchen Recalls Frozen Vegetable Lasagna Due to Metal Contamination Risk

    Amy's Kitchen is recalling specific lots of frozen gluten-free vegetable lasagna sold in the UK due to potential metal contamination.

    Product
    Amy's Kitchen gluten Free Vegetable Lasagna, UK Microwave or oven bake - keep frozen Item # 000374, UPC 0 042272 003747 net weight 255g Amy's Kitchen Bedford MK
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1104-2020·2020-04-15

    Avet Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Avet Pharmaceuticals is recalling Losartan Potassium Tablets 100 mg because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutica
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1131-2020·2020-04-15

    FDA Recalls Hernia Off for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Hernia Off because the product is misbranded as an unapproved new drug.

    Product
    Hernia Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-1116-2020·2020-04-15

    Herbal Doctor Remedies Recalls Dermamycin Capsules for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Dermamycin 500mg capsules because the products are misbranded as unapproved new drugs.

    Product
    Dermamycin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1675-2020·2020-04-15

    AAP Implantate Soft Tissue Retractor Recalled for Manufacturing Defect

    AAP Implantate AG is recalling 7 units of soft tissue retractors because they may not be fully removed during manufacturing, potentially leaving debris in patients.

    Product
    aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1681-2020·2020-04-15

    Solta Medical Recalls Thermage Face Tips Due to Sparking and Burn Risk

    Solta Medical is recalling Thermage Face Tip 3.0 units because sparking during use could cause skin burns.

    Product
    Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1660-2020·2020-04-15

    Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet, Inc. is recalling 230,001 units of StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1682-2020·2020-04-15

    Change Healthcare Cardiology ECG Software Recalled for Heart Rate Estimation Errors

    Change Healthcare Canada Company is recalling McKesson and Change Healthcare Cardiology ECG Management software due to potential inaccurate heart rate estimation in Sequential ECG format.

    Product
    McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1683-2020·2020-04-15

    Firefly Child Seats Recalled Due to Broken Latches

    James Leckey Design Ltd is recalling Firefly child seats because of reports of broken latches.

    Product
    Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo Seat is a light-weight, portable, postural support seat for kids, aged between 1 and 8 with disabilities.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1638-2020·2020-04-15

    Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns

    Biomet, Inc. is recalling 230,001 units of StageOne Hip Cement Spacer Molds because of potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Food)·F-0881-2020·2020-04-15

    Audrey's Chia Cookies Lemon Recalled for Undeclared Milk Allergen

    Health Harvest, LLC is recalling Audrey's Chia Cookies Lemon due to undeclared milk allergen. The product was distributed in Arizona and California.

    Product
    Audrey's Chia Cookies Lemon, 4 OZ flexible pouch packaging, UPC Code: 858652007010, Manufactured for Health Harvest, LLC, P.O. Box 20634, Mesa, AZ 85277. 12 pouches/case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0882-2020·2020-04-15

    Audrey's Chia Cookies Peanut Butter Recalled for Undeclared Milk Allergen

    Health Harvest, LLC is recalling Audrey's Chia Cookies Peanut Butter because the product contains undeclared milk, a major food allergen.

    Product
    Audrey's Chia Cookies Peanut Butter, 4 OZ flexible pouch packaging, UPC Code: 858652007034, Manufactured for Health Harvest, LLC, P.O. Box 20634, Mesa, AZ 85277. 12 pouches/case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1642-2020·2020-04-15

    Biomet Recalls StageOne Hip Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling StageOne Hip Cement Spacer Molds because the cleaning process may have been insufficient or inadequately monitored.

    Product
    BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1689-2020·2020-04-15

    Bard Jamshidi Bone Marrow Biopsy Needle Recalled for Sterility Compromise

    Bard Peripheral Vascular Inc is recalling Jamshidi Bone Marrow Biopsy/Aspiration Needles because packaging pouches may not be sealed properly, compromising sterility.

    Product
    Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2020·2020-04-15

    Abbott ARCHITECT C System Mixer Recall Due to Blade Separation Risk

    Abbott is recalling ARCHITECT C System Mixers because the blade may separate from the mixer due to screw and nut failure, leading to inadequate mixing of samples and reagents.

    Product
    ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The mixer is a component and it is used on all ARCHITECT Clinical Chemistry systems to mix the s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1643-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1674-2020·2020-04-15

    Beckman Coulter MicroScan PROMPT Inoculation System-D Recalled for Incorrect Wands

    Beckman Coulter is recalling 3,472 units of the MicroScan PROMPT Inoculation System-D because they contain incorrect prompt wands, which may cause inaccurate antimicrobial susceptibility test results.

    Product
    Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility test.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0878-2020·2020-04-15

    FDA Recalls Nature's Earthly Choice Organic Lentil Trio for Gluten Contamination

    Global Juices & Fruits LLC is recalling Nature's Earthly Choice Organic Lentil Trio because the product tested positive for gluten and contained barley and wheat.

    Product
    Nature's Earthly Choice Organic Lentil Trio product containing a blend of red split, black and green lentils, labeled Gluten-Free, packaged in stand up resealable pouch, 12 oz. (340 g), UPC 6 79948 10006 8. The product's label is read in parts: "*** Gluten-Free *** ORGANIC LEN
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1647-2020·2020-04-15

    Biomet Hip Stem Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling 230,001 hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Food)·F-0884-2020·2020-04-15

    Kroger Recalls Private Selection Frozen Berry Medley for Norovirus Risk

    The Kroger Co is recalling Private Selection Frozen Berry Medley due to potential norovirus contamination. Consumers should check their freezers for affected bags.

    Product
    PRIVATE SELECTION FROZEN BERRY MEDLEY in 16 oz. (10 bags per case) and 48 oz. bags (6 bags per case). UPC: 0001111079120
    Category
    Food
    Distribution
    31 states
  • HighFDA (Food)·F-0883-2020·2020-04-15

    Lindt Excellence Dark Chocolate Recalled for Undeclared Milk and Soy

    Lindt & Sprungli is recalling 174,288 bars of Excellence 85% Cocoa Dark Chocolate because they contain undeclared milk and soy.

    Product
    Lindt & Sprungli (USA), Inc.; Excellence 85% Cocoa Dark Chocolate; Net WT 3.5OZ (100g)
    Category
    Food
    Distribution
    37 states
  • HighFDA (Devices)·Z-1688-2020·2020-04-15

    Abbott Recalls Hemoglobin A1c Calibrators Due to Potential Test Bias

    Abbott Laboratories is recalling 198 kits of Hemoglobin A1c Calibrators because a manufacturing defect may cause biased patient test results outside a specific concentration range.

    Product
    "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0880-2020·2020-04-15

    Audrey's Chia Cookies Almond Recalled for Undeclared Milk Allergen

    Health Harvest, LLC is recalling Audrey's Chia Cookies Almond because the product contains undeclared milk, a major food allergen.

    Product
    Audrey's Chia Cookies Almond, 4 OZ flexible pouch packaging, UPC Code: 858652007027, Manufactured for Health Harvest, LLC, P.O. Box 20634, Mesa, AZ 85277. 12 pouches/case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0885-2020·2020-04-15

    Kroger Private Selection Frozen Blackberries Recalled for Norovirus Risk

    The Kroger Co is recalling Private Selection Frozen Blackberries due to potential norovirus contamination. Consumers should check their freezers for affected bags.

    Product
    PRIVATE SELECTION FROZEN BLACKBERRIES in 16 oz. bags, 10 bags per case. UPC: 0001111087809 UPC: 0001111087808
    Category
    Food
    Distribution
    31 states
  • HighFDA (Devices)·Z-1641-2020·2020-04-15

    Biomet Hip Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Food)·F-0879-2020·2020-04-15

    Audrey's Chia Cookies Recalled for Undeclared Milk Allergen

    Health Harvest, LLC is recalling Audrey's Chia Cookies Chocolate Chip due to undeclared milk allergen. The product was distributed in Arizona and California.

    Product
    Audrey's Chia Cookies Chocolate Chip, 4 OZ flexible pouch packaging, UPC Code: 858652007003, Manufactured for Health Harvest, LLC, P.O. Box 20634, Mesa, AZ 85277. 12 pouches/case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1654-2020·2020-04-15

    Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns

    Biomet, Inc. is recalling 230,001 units of StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1684-2020·2020-04-15

    Radiometer ABL800 FLEX Blood Gas Analyzer Barcode Reader Recall

    Radiometer Medical ApS is recalling ABL800 FLEX analyzers because the barcode reader may misinterpret labels, potentially causing patient mixups or sample loss.

    Product
    ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) In
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1645-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Drugs)·D-1110-2020·2020-04-15

    Herbal Doctor Remedies Recalls Asma Stopper Capsules for Misbranding

    Herbal Doctor Remedies is recalling Asma Stopper capsules because they are misbranded as unapproved new drugs.

    Product
    Asma Stopper, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1149-2020·2020-04-15

    Herbal Doctor Remedies Recalls PC Shrinker Due to Misbranding

    Herbal Doctor Remedies is recalling PC Shrinker because the product was found to be misbranded as an unapproved new drug.

    Product
    PC Shrinker, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1666-2020·2020-04-15

    Biomet Recalls Knee Tibial Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Drugs)·D-1153-2020·2020-04-15

    Purple Gold Balm Recalled for Misbranding as Unapproved New Drug

    Herbal Doctor Remedies is recalling Purple Gold Balm because it is misbranded as an unapproved new drug. The product was sold online in the US and internationally.

    Product
    Purple Gold Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1144-2020·2020-04-15

    Herbal Doctor Remedies Recalls Metabolic Booster Capsules for Misbranding

    Herbal Doctor Remedies is recalling Metabolic Booster 500mg capsules because they are misbranded as unapproved new drugs.

    Product
    Metabolic Booster. 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1118-2020·2020-04-15

    Herbal Doctor Remedies Recalls DeTensin Ex for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling DeTensin Ex because the product is misbranded as an unapproved new drug. The recall covers all lots within expiry sold in the US and internationally.

    Product
    DeTensin Ex, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1639-2020·2020-04-15

    Biomet Recalls StageOne Hip Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 units of StageOne Hip Cement Spacer Molds because of potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1648-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet, Inc. is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1686-2020·2020-04-15

    Baxter Recalls GEM Microvascular Couplers Due to Labeling Mismatch

    Baxter Healthcare is recalling 209 GEM Microvascular Anastomotic Coupler Devices because the size labeling on the outer tray may not match the inner tray.

    Product
    GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1653-2020·2020-04-15

    Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns

    Biomet, Inc. is recalling 230,001 units of BIOMET StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1650-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1659-2020·2020-04-15

    Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1646-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet, Inc. is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.
    Category
    Medical Device
    Distribution
    49 states

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