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.

401–500 of 605

  • SevereFDA (Devices)·Z-1567-2020·2020-04-08

    LeMaitre Embolectomy Catheter Recall for Deflation Failure and Tip Separation

    LeMaitre Vascular is recalling 5F Plus Over the Wire Embolectomy Catheters due to reports of deflation failure that may lead to tip separation.

    Product
    LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for cathe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E019000·2020-04-08

    Agility Fuel Solutions Recalls CNG Pressure Relief Devices for Rupture Risk

    Agility Fuel Solutions is recalling certain CNG pressure relief devices that may fail to vent when exposed to heat, potentially causing the fuel system to rupture.

    Product
    FUEL SYSTEM, OTHER:STORAGE:TANK ASSEMBLY:PRESSURE RELIEF DEVICES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1622-2020·2020-04-08

    Philips V60 Ventilators Recalled for Power Management Board Failure

    Respironics is recalling 23,581 Philips V60 Ventilators because a solder connection failure on the power board may cause the blower to lose power or shut down unexpectedly, potentially leading to hypercarbia or hypoxemia.

    Product
    Philips V60 Ventilators with Power Management PCBA part number 1055906
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Drugs)·D-1077-2020·2020-04-08

    Medical Center Pharmacy Recalls Mitomycin Eye Drops Due to Sterility Concerns

    Medical Center Pharmacy is recalling two bottles of Mitomycin 0.04% Ophth DR eye drops because production processes could not assure sterility.

    Product
    *Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1632-2020·2020-04-08

    Merits E604 Pilot Navigator Stairlift Recalled Due to Pinion Gear Defect

    Merits Health Products is recalling 82 E604 Pilot Navigator Stairlifts because the pinion gear may disengage from the track, allowing the lift to slip or jolt.

    Product
    Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1602-2020·2020-04-08

    Stryker Recalls Ceiling Mounted Surgical Light Systems Due to Fall Risk

    Stryker is recalling 1,415 Berchtold Chromophare Ceiling Mounted Surgical Light Systems because a missing snap ring or spanner nut may cause the light to fall.

    Product
    Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1074-2020·2020-04-08

    Medical Center Pharmacy Recalls Vancomycin Opthal Drops Due to Sterility Concerns

    Medical Center Pharmacy is recalling Vancomycin Opthal 14 mg drops because production processes could not assure sterility. The product was distributed to patients in Tennessee.

    Product
    C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1076-2020·2020-04-08

    Medical Center Pharmacy Recalls Gentamicin Bladder Irrigation Bags

    Medical Center Pharmacy is recalling 250 mL bags of Gentamicin/Bacitracin Bladder Irrigation due to concerns that production processes cannot assure sterility.

    Product
    C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 63323-0010-02.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1073-2020·2020-04-08

    Medical Center Pharmacy Recalls C-Albumin Eye Drops Due to Sterility Concerns

    Medical Center Pharmacy is recalling specific lots of C-Albumin Eye Drop 10% S because production processes cannot assure sterility. Patients in Tennessee who received these prescriptions should contact their healthcare provider.

    Product
    C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 44206-0251-05.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1071-2020·2020-04-08

    Par Pharmaceutical Recalls Glycopyrrolate Tablets Due to Unknown Impurity

    Par Pharmaceutical is recalling 29,352 bottles of Glycopyrrolate Tablets, USP 1 mg, because an unknown impurity was detected.

    Product
    Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1072-2020·2020-04-08

    Gentamicin Irrigation Recalled for Lack of Sterility Assurance

    The Medicine Shoppe Pharmacy is recalling Gentamicin 80mg/60 mL Irrigation containers due to a lack of assurance of sterility.

    Product
    Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·20V203000·2020-04-08

    Spartan Gladiator and MetroStar Recalled for Park Brake Line Defect

    Marion Body Works is recalling 2019-2020 Spartan Gladiator and MetroStar vehicles because the park brake control line may loosen, potentially causing sudden deceleration and increasing crash risk.

    Product
    SPARTAN — SPARTAN METROSTAR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0863-2020·2020-04-08

    Tiffany Food Corp. Recalls Dried Mushroom for Undeclared Sulfites

    Tiffany Food Corp. is recalling 1,500 units of Huangfushanzhen Dried Mushroom because the product contains undeclared sulfites.

    Product
    HUANGFUSHANZHEN; Dried Mushroom; Net Weight: 170G/6 OZ; Ingredient: Dried Mushroom; PRODUCT OF CHINA; SOLE AGENT: TIFFANY FOOD CORP; UPC: 6 943153 804047
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-1075-2020·2020-04-08

    Morphine 2 mg/mL CADD Cassettes Recalled for Sterility Concerns

    Medical Center Pharmacy is recalling Morphine 2 mg/mL CADD Cassettes because production processes cannot assure sterility. Patients in Tennessee who received specific prescriptions should contact their healthcare provider.

    Product
    *Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 00409-1134-03.
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·20V206000·2020-04-08

    Vac-Tron Vacuum Excavator Trailers Recalled for Rear Impact Protection Defect

    Vac-Tron is recalling 2012-2020 vacuum excavator trailers because they may lack extended lower chassis, reducing rear impact protection and increasing crash risk.

    Product
    VAC-TRON — VAC-TRON MINICOMBO, MC 873 SDT, MC 835 SDT, MC 833 SDT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2020·2020-04-08

    Maquet Recalls Avalon Elite Vascular Access Kits Due to Needle Mix-up

    Maquet is recalling 255 Avalon Elite Vascular Access Kits because 81 units were assembled with an incorrect arterial needle instead of a multi-purpose needle.

    Product
    Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Food)·F-0871-2020·2020-04-08

    ReStructure Vanilla Protein Powder Recalled for Missing Milk Labeling

    New Capstone, Inc. is recalling ReStructure Vanilla Protein Powder because the ingredient statement does not include the word milk.

    Product
    ReStructure VANILLA PROTEIN POWDER NET WT. 527G POUCH & 27G SINGLE PACKET Other Ingredients: Non-GMO rBGH-Free Whey Protein Concentrate, Rice Bran and Germ*** Manufactured for & distributed by: New Capstone, Inc. 125 Trade Court, Suite F44, Mooresville, NC 28117 1-888-577-3703 UP
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1634-2020·2020-04-08

    Smith & Nephew Recalls NAVIO Soft Tissue Protector Due to Binding Risk

    Smith & Nephew is recalling 348 NAVIO Soft Tissue Protectors because the instrument may become stuck to bone pins during surgery.

    Product
    NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected whe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2020·2020-04-08

    Karl Storz C-MAC Video Laryngoscope Recall Due to Loose Glass Cover

    Karl Storz is recalling 27,165 C-MAC Video Laryngoscopes because the glass cover at the distal end may become loose during use or reprocessing, potentially delaying procedures or requiring removal from the body.

    Product
    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Produc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0870-2020·2020-04-08

    McClancy Dirty Rice Mix Recalled for Blue Plastic Slivers

    McClancy Seasoning Company is recalling Bojangles Complete Dirty Rice Mix because it contains blue plastic slivers. The product was distributed to Florida, Georgia, and North Carolina.

    Product
    Case Label: Rice Dirty Mix Comp 24-17.9 oz bags/case, PACKED EXCLUSIVELY FOR: BR 9432 SOUTHERN PINE BLVD. CHARLOTTE, NC 28273. Bag Label: Bojangles Complete Dirty Rice Mix Net Wt: 17.9 oz bags
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1621-2020·2020-04-08

    Stryker AXS Vecta 74 Aspiration Catheter Recall for Potential Fracture

    Stryker Neurovascular is recalling 1,405 AXS Vecta 74 Aspiration Catheters because they may break, fracture, or kink if improperly removed or during use.

    Product
    Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459241(17)211129(10)00000-00 Stryker Neurovascula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0873-2020·2020-04-08

    Raw Seafoods Recalls Frozen Ginger Salmon for Undeclared Wheat

    Raw Seafoods Inc. is recalling 554 cases of frozen oven-safe Ginger Salmon due to undeclared wheat. The product was distributed in seven northeastern and mid-Atlantic states.

    Product
    Food You Feel Good About, Ginger Salmon, Oven Safe
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0864-2020·2020-04-08

    Meijer Mixed Nuts Recalled for Undeclared Brazil Nuts

    Meijer Inc. is recalling 8,200 packages of Mixed Nuts with Peanuts & Sea Salt due to undeclared Brazil nuts. The product was sold in six states.

    Product
    Meijer Mixed Nuts with Peanuts & Sea Salt 16 Oz UPC: 7-19283-80863-9
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1604-2020·2020-04-08

    DeRoyal Security Cuffs Recalled for Insufficient Buckle Hold Force

    DeRoyal is recalling 94 pairs of security cuffs because the buckles do not meet required mechanical hold force standards.

    Product
    DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
    Category
    Medical Device
    Distribution
    4 states
  • HighNHTSA·20V205000·2020-04-08

    Toyota Recalls 2020 Corolla Hatchbacks for Backup Light Failure Risk

    Toyota is recalling 2020 Corolla Hatchbacks because a damaged wire harness may cause backup lights to fail, increasing crash risk while reversing.

    Product
    TOYOTA — TOYOTA COROLLA HATCHBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0874-2020·2020-04-08

    Raw Seafoods Recalls Frozen Salmon Teriyaki for Undeclared Wheat

    Raw Seafoods Inc. is recalling frozen Salmon Teriyaki products due to undeclared wheat. The recall affects specific states and products with specific best-by dates.

    Product
    Food You Feel Good About Brand, Salmon Teriyaki, Oven Safe
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1637-2020·2020-04-08

    Bard WavelinQ 4F EndoAVF System Recalled for Magnetic Deficiency

    Bard Peripheral Vascular is recalling 150 units of the WavelinQ 4F EndoAVF System because magnetic catheters may fail to attract, potentially delaying fistula creation.

    Product
    BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The WavelinQ 4F EndoAVF System in indicated for the creation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1633-2020·2020-04-08

    Physio-Control Recalls LifePAK 500 AEDs Due to Contact Plating Wear

    Physio-Control is recalling 173,459 LifePAK 500 AEDs because mechanical wear on the therapy connector may prevent the device from detecting a patient, potentially delaying treatment.

    Product
    LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient s ele
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1631-2020·2020-04-08

    Ra Medical Systems Recalls Pharos Excimer Laser Due to Software Error

    Ra Medical Systems is recalling 10 Pharos EX-308 Excimer Laser units because a software error may prevent the device from stopping, potentially causing skin burns.

    Product
    Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototherapy. The excimer laser system produces collimated 308 nm radiation, within the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0877-2020·2020-04-08

    Vitamin Cottage Almond Clusters Recalled for Undeclared Peanut and Milk Allergens

    Vitamin Cottage is recalling Natural Grocers Almond Clusters in Dark Chocolate because the product contains undeclared peanut and milk allergens.

    Product
    NATURAL GROCERS ALMOND CLUSTERS DK CHOCOLATE NON-GMO, 8 oz. (227g), packed in a plastic bag, UPC 000087236088, Packaged by Vitamin Cottage Natural Food Markets, Inc., Lakewood, CO 80228
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-1620-2020·2020-04-08

    Stryker AXS Vecta 71 Aspiration Catheter Recall for Breakage Risk

    Stryker Neurovascular is recalling AXS Vecta 71 Aspiration Catheters because they may break, fracture, or kink if improperly removed or during use.

    Product
    Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459210(17)211129(10)00000-00 Stryker Neurovascula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0875-2020·2020-04-08

    Advanced Fresh Concepts Recalls Cooked Butterfly Shrimp Due to Vibrio

    Advanced Fresh Concepts Corp is recalling cooked butterfly shrimp after firm testing detected Vibrio parahaemolyticus. The product was distributed in 38 states.

    Product
    Sushi Ebi Cooked Butterfly Tail-On Whiteleg Shrimp; Tray +0.498 pounds; 20 individual trays per case Distributed by AFC Distribution Corp. Rancho Dominguez, CA
    Category
    Food
    Distribution
    40 states
  • HighFDA (Food)·F-0876-2020·2020-04-08

    Vitamin Cottage Peanut Clusters Recalled for Undeclared Almond and Milk Allergens

    Vitamin Cottage Natural Food Markets is recalling Natural Grocers Peanut Clusters due to undeclared almond and milk allergens. Consumers should check their pantry and stop eating the product.

    Product
    NATURAL GROCERS PEANUT CLUSTERS DK CHOCOLATE NON-GMO, 8 oz. (227g), packed in a plastic bag, UPC 000087562088, Packaged by Vitamin Cottage Natural Food Markets, Inc., Lakewood, CO 80228
    Category
    Food
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-1608-2020·2020-04-08

    Trilliant Surgical Disco Subtalar Implant Instructions for Use Recall

    Trilliant Surgical, LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for the Disco Subtalar Implant System to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco Subtalar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1611-2020·2020-04-08

    Trilliant Surgical 3S Hemi Toe Implant Instructions for Use Recall

    Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for the 3S Hemi Toe Implant System to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S Hemi Toe Implant System, Model 111-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1623-2020·2020-04-08

    Gentell Hydrogel Ag Gauze Recalled for FDA Registration Failure

    Gentell, Inc. is recalling 53,134 units of Gentell Hydrogel Ag 2x2 gauze because the product was not properly registered with the FDA.

    Product
    Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second deg
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0865-2020·2020-04-08

    Driscoll's Recalls Blackberries Due to Acephate Pesticide Residue

    Driscoll's is recalling fresh blackberries because testing found Acephate pesticide residue at 2.8 ppm, a level with no established US maximum residue limit.

    Product
    Driscoll's Blackberries; 6 oz. clamshell container; 12 x 6 oz. clamshells per tray; 12 clamshells per case Driscoll's, Watsonville, CA
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1636-2020·2020-04-08

    Qiagen AmniSure ROM Test Recalled for Incorrect Rinse Time Labeling

    Qiagen Sciences LLC is recalling AmniSure ROM Test kits because the packaging displays an incorrect rinse time of 30 seconds instead of the correct 1 minute.

    Product
    AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1614-2020·2020-04-08

    Trilliant Surgical Small Joint Reaming System Instructions for Use Recall

    Trilliant Surgical LLC is recalling Instructions for Use and Cleaning Protocols for the Small Joint Reaming System to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Small Joint Reaming System, Model 311-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1635-2020·2020-04-08

    Trilliant Surgical Recalls 8mm Hammer Toe Reaming Kits Due to Incorrect Contents

    Trilliant Surgical is recalling 117 units of 8mm HTR Sterile Hammer Toe Reaming Kits because they may contain two identical reamers instead of one concave and one convex reamer.

    Product
    8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-1612-2020·2020-04-08

    Trilliant Surgical Recalls Instructions for Use for Cannulated Screw Systems

    Trilliant Surgical, LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for two cannulated screw systems to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 215-00-001; and (2) Trilliant Surgical Ltd Large Cannulated Headless Screw System, Model 215-00-001. The firm name on the labe
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1617-2020·2020-04-08

    Haemonetics Recalls TEG Manager Software Due to Alert Display Defect

    Haemonetics is recalling TEG Manager software versions 1.1.0 through 4.1.1 because a defect causes incorrect out-of-range alerts for coagulation test results.

    Product
    TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1619-2020·2020-04-08

    Binding Site C-Reactive Protein Kit Recalled for Reagent Performance Issues

    The Binding Site Group is recalling C-Reactive Protein Kits because a reagent is not performing to specification, potentially affecting low-concentration samples.

    Product
    C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1630-2020·2020-04-08

    Natus Olympic Brainz Monitor Recalled for Missing Functional Tests

    Natus Neurology is recalling 40 Olympic Brainz Monitors because required functional tests were not performed before release, meaning the manufacturer cannot verify system functionality.

    Product
    natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1605-2020·2020-04-08

    Trilliant Surgical Recalls Instructions for Use for Tiger Screw Systems

    Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for Tiger Cannulated Screw Systems to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001; and (2) Combination Tiger/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name on the label is Trilliant S
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1609-2020·2020-04-08

    Trilliant Surgical Gridlock Plating System Instructions for Use Recall

    Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for the Gridlock Plating System to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Plating System, Model 310-01-100. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1600-2020·2020-04-08

    Butterfly iQ Ultrasound System Auto Bladder Volume Tool Recalled for Regulatory Violation

    Butterfly Network, Inc. is recalling the Butterfly iQ Ultrasound System Auto Bladder Volume Tool because it was distributed without an approved 510(k).

    Product
    Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1628-2020·2020-04-08

    Conformis Recalls iTotal PS Knee Replacement System Due to Labeling Error

    Conformis is recalling two iTotal PS Knee Replacement System kits because tibial trays were labeled with incorrect serial numbers and delivered to the wrong customers.

    Product
    iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be sol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1610-2020·2020-04-08

    Trilliant Surgical Recalls Hammertoe Implant Instructions for Use

    Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for its Two-Step Hammertoe Implant System to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two-Step Hammertoe Implant System, Model 214-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Food)·F-0868-2020·2020-04-08

    NutraBlend Russian Bear Weight Gainer Recalled for Undeclared Soy

    NutraBlend Foods is recalling Russian Bear 10000 Weight Gainer Formula Banana flavor due to undeclared soy protein isolate.

    Product
    Russian Bear 10000 Weight Gainer Formula Banana flavor packed in 15lb bags
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1627-2020·2020-04-08

    Conformis Recalls iTotal CR Knee Replacement System Due to Labeling Error

    Conformis, Inc. is recalling four iTotal CR Knee Replacement System kits because they were labeled with incorrect serial numbers and delivered to the wrong customers.

    Product
    iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0866-2020·2020-04-08

    NutraBlend Russian Bear Weight Gainer Recalled for Undeclared Soy

    NutraBlend Foods is recalling Russian Bear 10000 Weight Gainer Formula Vanilla due to undeclared soy protein isolate. The product was distributed to one customer in Canada.

    Product
    Russian Bear 10000 Weight Gainer Formula Vanilla packed in 15lb bags
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1624-2020·2020-04-08

    Gentell Hydrogel Ag Gauze Recalled for FDA Registration Deficiency

    Gentell, Inc. is recalling 20,025 units of Gentell Hydrogel Ag 4x4 gauze because the product was not properly registered with the FDA.

    Product
    Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1615-2020·2020-04-08

    Biomet Shoulder Baseplate Recall Due to Incorrect Packaging Contents

    Biomet is recalling 21 units of Comprehensive Reverse Shoulder Glenosphere Mini Baseplates because some packages contained two baseplates and no taper adapters.

    Product
    Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency Item Number: 010000589
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1601-2020·2020-04-08

    Butterfly iQ Ultrasound System Recalled for Lack of FDA Approval

    Butterfly Network, Inc. is recalling 11,183 Butterfly iQ Ultrasound Systems because they were distributed without an approved 510(k).

    Product
    Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0 Product Usage: Intended use: Diagnostic ultrasound imaging and measurement of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1606-2020·2020-04-08

    Trilliant Surgical Recalls Instructions for Use for Tiger Screw Systems

    Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for Tiger Screw Systems to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw System, Model 212-00-001; and (2) Combination Tiger Cannulated/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name on
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1613-2020·2020-04-08

    Trilliant Surgical Gridlock Ankle Plating System Instructions for Use Recalled

    Trilliant Surgical LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for the Gridlock Ankle Plating System to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Ankle Plating System, Model 320-01-100. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Drugs)·D-1079-2020·2020-04-08

    Lupin Recalls Lisinopril Tablets Due to Foreign Tablet Mix-Up

    Lupin Pharmaceuticals is recalling 25,944 bottles of Lisinopril 30 mg tablets because a 5 mg tablet was found mixed into a 30 mg bottle.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1616-2020·2020-04-08

    Philips Recalls MRI Patient Monitoring Systems Due to Incorrect Calibration Instructions

    Philips is recalling 2,214 MRI Patient Monitoring Systems because the instructions for oxygen sensor calibration are incorrect for specific software versions.

    Product
    Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product Usage: The Expression Model MR400 MRI Patient Monitoring Systems is intended for use by healthcare professionals to monitor vital s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1607-2020·2020-04-08

    Trilliant Surgical Twist Sublatar Implant System Instructions for Use Recall

    Trilliant Surgical, LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for the Twist Sublatar Implant System to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.
    Category
    Medical Device
    Distribution
    29 states
  • LowFDA (Food)·F-0872-2020·2020-04-08

    Nature's Blend Folic Acid Recalled for Labeling Error

    National Vitamin Company is recalling Nature's Blend Folic Acid 1000 mcg bottles due to a front panel label error stating 1000 mg instead of 1000 mcg.

    Product
    Nature's Blend Folic Acid 1000 mcg Dietary Supplement, 1000-count bottle, Product Number: 1280, UPC 0-79854-51280-9
    Category
    Food
    Distribution
    18 states
  • LowFDA (Devices)·Z-1625-2020·2020-04-08

    Gentell Hydrogel Ag Saturated Gauze Recalled for FDA Registration Deficiency

    Gentell, Inc. is recalling 6,433 units of Gentell Hydrogel Ag Saturated Gauze because the product was not properly registered with the FDA.

    Product
    Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1258-2020·2020-04-08

    Akorn Recalls Fentanyl Citrate Injection Due to Impurity Specification Failure

    Akorn Inc. is recalling Fentanyl Citrate Injection, USP, 100 mcg/2 mL, because retained sample testing showed total impurities exceeded the allowed limit.

    Product
    Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1626-2020·2020-04-08

    Gentell Hydrogel Ag Wound Dressing Recalled for Registration Issues

    Gentell, Inc. is recalling Gentell Hydrogel Ag wound dressings because the product was not properly registered with the FDA.

    Product
    Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, fir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V204000·2020-04-07

    Vac-Tron Recalls 2012-2020 Vacuum Excavator Trailers for Lighting Defects

    Vac-Tron is recalling 2012-2020 vacuum excavator trailers because improper exterior lighting and missing reflectors may reduce visibility at night, increasing crash risk.

    Product
    VAC-TRON — VAC-TRON MC 873 SDT, MC 855 SDT, MC 833 SDT, MC 835 SDT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V201000·2020-04-07

    Vac-Tron Recalls Vacuum Excavator Trailers for Lighting Defects

    Vac-Tron is recalling 2012-2020 vacuum excavator trailers because improper lighting and missing reflectors may reduce visibility at night, increasing crash risk.

    Product
    VAC-TRON — VAC-TRON MC 535, MC 533 SDT, MINICOMBO, MC 573 SDT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V198000·2020-04-06

    KTM Recalls 2019-2020 790 Adventure Models Due to Rear Brake Hose Overheating

    KTM is recalling 2019-2020 790 Adventure and 790 Adventure R motorcycles because the rear brake hose may overheat, potentially causing brake failure and increasing crash risk.

    Product
    KTM — KTM 790 ADVENTURE R, 790 ADVENTURE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V193000·2020-04-03

    Isuzu Recalls 2019 NPR Vehicles Due to Brake Line Clip Defect

    Isuzu is recalling 2019 NPR and Chevrolet 4500 vehicles because incorrectly installed brake line clips may cause rear driver-side brake failure.

    Product
    ISUZU — ISUZU NPR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V196000·2020-04-03

    Trans Tech Bus Recalls 2020 Models for Seatbelt Warning Light Defect

    Trans Tech Bus is recalling 446 specific 2020 Roadstar, SST, and ST Aero buses because the seatbelt-unfastened warning light may not illuminate for five seconds after ignition.

    Product
    TRANS TECH — TRANS TECH ROADSTAR, SST, ST AERO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V190000·2020-04-02

    Setra S417TC Coaches Recalled for Front Door Detachment Risk

    Daimler Coaches is recalling 2017-2020 Setra S417TC coaches because the front entrance door support frame may be the wrong size, allowing the door to detach while moving.

    Product
    SETRA — SETRA S417 TC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20104·2020-04-02

    VP Harrier and Giant Pinner DH Bicycle Pedals Recalled for Fall Hazards

    VP Components is recalling Harrier and Giant Pinner DH bicycle pedals because the spindle can separate from the pedal body, posing fall and injury hazards.

    Product
    VP Harrier and Giant Pinner DH bicycle pedals
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20102·2020-04-02

    Manhattan Toy Recalls Musical Lili Llama Due to Choking Hazard

    Manhattan Toy is recalling Musical Lili Llama wooden activity toys because loose screws can fall off, posing a choking hazard to young children.

    Product
    Musical Lili Llama
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20105·2020-04-02

    Stelpro Recalls Sonoma Wall Fan Heaters Due to Fire Hazard

    Stelpro Design is recalling about 3,600 Sonoma wall fan heaters because an internal part poses a fire hazard. Consumers should stop using the units and contact Stelpro for a free replacement.

    Product
    ASSO and ASSOS Sonoma wall fan heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V192000·2020-04-02

    KME Emergency Vehicles Recalled for Battery Corrosion Electrical Short Risk

    KME is recalling 2016-2020 emergency vehicles because battery corrosion can cause electrical shorts, potentially draining the battery and preventing operation during emergencies.

    Product
    KME — KME COMMERCIALCAB/ CHASSIS, PREDATOR PANTHER, PREDATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0886-2020·2020-04-01

    Clover Seed Recalled Due to Possible E. Coli Contamination

    International Sprout Holding Inc. is recalling clover seed in 50 lb. bags due to possible E. Coli contamination. The product was distributed to multiple states, territories, and countries.

    Product
    Clover seed in 50 lb. woven poly bags, 40 bags to a pallet.
    Category
    Food
    Distribution
    19 states
  • SevereFDA (Food)·F-0890-2020·2020-04-01

    Hong Bin Foods Recalls Enoki Mushrooms Due to Listeria Risk

    Hong Bin Foods LLC is recalling Enoki Mushrooms after testing by the State of Michigan found Listeria monocytogenes. The product was distributed in six states.

    Product
    Enoki Mushroom; Product of Korea; Net Wt. 7.05 oz., (200 g) UPC: 7 426852 625810 The Enoki is packaged in a clear film, bottom portion will be a green back group. With Enoki Mushroom in Orange letters, under that will be Product of Korea, 7.05 oz / 200g Sun Hong Foods,
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1587-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pumps Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 88,243 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1053-2020·2020-04-01

    Thrive Pharmacy Recalls Subpotent Buprenorphine Troches in Florida

    Thrive Pharmacy is recalling 403 buprenorphine troches in Florida because they contain less active ingredient than labeled.

    Product
    Buprenorphine Watermelon 8 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0887-2020·2020-04-01

    International Sprout Holding Recalls Clover Seed for E. Coli Contamination

    International Sprout Holding Inc. is recalling 13,455 lbs of clover seed due to possible E. Coli contamination. The product was distributed to multiple US states, territories, and countries.

    Product
    Clover seed in 55 lb. multi-layered white paper bags, 40 bags to a pallet.
    Category
    Food
    Distribution
    19 states
  • SevereFDA (Drugs)·D-1052-2020·2020-04-01

    Thrive Pharmacy Recalls Subpotent Buprenorphine Troches in Florida

    Thrive Pharmacy is voluntarily recalling 71 Buprenorphine troches in Florida because the medication was found to be subpotent.

    Product
    Buprexone Banana cream 6-0.6 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1527-2020·2020-04-01

    ev3 Pipeline Flex Embolization Device Recalled for Potential Fracture

    Micro Therapeutics Inc is recalling 1,050 ev3 Pipeline Flex Embolization Devices because the delivery system may fracture during implantation, potentially leaving a part in the patient.

    Product
    ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1589-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pumps Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 38 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1054-2020·2020-04-01

    Thrive Pharmacy Recalls Subpotent Buprenorphine Troches in Florida

    Thrive Pharmacy is recalling 89 Buprenorphine Black Cherry 2 mg troches in Florida because the medication was found to be subpotent.

    Product
    Buprenorphine Black Cherry 2 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0857-2020·2020-04-01

    WinCo Foods Recalls Frozen Berry Medley Due to Norovirus Contamination

    WinCo Foods is recalling 21,264 bags of frozen Berry Medley because the product was found to be adulterated with Norovirus.

    Product
    WinCo Foods frozen Berry Medley (Strawberries, Blackberries, Raspberries and Blueberries), item# 107412, packaged in polyethylene bags. Product is distributed by WinCo Foods, LLC, Boise, ID 83704. Net weight 16 oz (1 lb or 454 g). UPC 70552 30522. Net weight 32 oz (2 lb or
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1591-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 23,221 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1569-2020·2020-04-01

    Skytron Monitor Bracket Recalled for Weld Failure Risk

    Skytron is recalling 43 monitor brackets because a weld may fail, causing the display to fall and potentially injure users.

    Product
    Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-0846-2020·2020-04-01

    Whole Foods Market Green Chile Chicken Tamale Recalled for Undeclared Milk

    Whole Foods Market is recalling Green Chile Chicken Tamales because they contain undeclared milk, posing a risk to individuals with milk allergies.

    Product
    Whole Foods Market Green Chile Chicken Tamale served as a Family Meal, Chef's Case, Packaged, Frozen and on he hot bar PLU 72429 packaged in plastic containers and in family-style meal kits
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-1595-2020·2020-04-01

    Medtronic MiniMed Paradigm Veo Insulin Pumps Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling Paradigm Veo insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1550-2020·2020-04-01

    Mavidon CardioPrep Single Recalled Due to Burkholderia cepacia Contamination

    Carroll-Baccari, Inc. is recalling Mavidon CardioPrep Single products because samples were found contaminated with Burkholderia cepacia.

    Product
    MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order # MCP-24
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2020.