The Recall Desk

Archive

February 2020 recalls

815 recalls were announced in February 2020.

What the numbers show

Critical
88
Severe
191
High
354
Moderate
163
Low
19

Of the 815 recalls this month scored against our rubric, 11% are Critical, 23% are Severe.

701–800 of 815

  • CriticalFDA (Food)·F-0568-2020·2020-02-05

    Knotts Fine Foods Recalls Egg Salad for Possible Listeria

    Knotts Fine Foods is recalling 12lb buckets of Egg Salad due to possible Listeria monocytogenes contamination in egg ingredients. The product was distributed to Mississippi and Tennessee.

    Product
    12lb plastic bucket of Egg Salad Sold as 2 - 12lb buckets per case
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0574-2020·2020-02-05

    Jeni's Dairy Free Cold Brew Pints Recalled for Undeclared Milk Allergen

    Jeni's Splendid Ice Creams LLC is recalling 49,358 pints of Dairy Free Cold Brew with Coconut Cream frozen dessert because they may contain undeclared milk.

    Product
    Jeni's Dairy Free Cold Brew with Coconut Cream Pints frozen dessert
    Category
    Food
    Distribution
    50 states
  • SevereFDA (Food)·F-0563-2020·2020-02-05

    Whole Foods Recalls Dark Chocolate Peppermint Sandwiches for Undeclared Milk

    Whole Foods Market is recalling 365 Everyday Value Dark Chocolate Peppermint Sandwich Cremes because they may contain undeclared milk.

    Product
    365 Everyday Value Dark Chocolate Peppermint Sandwich Cremes Net Wt 7.75 oz (220g) UPC 9948247605 Paper carton boxes sold individually
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0822-2020·2020-02-05

    Walgreens Acne Cleansing Bar Recalled for Metal Contaminant

    Shandex Personal Care Manufacturing Inc. is recalling Walgreens Acne Cleansing Bar due to the presence of a visible metal contaminant.

    Product
    Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, NDC: 0363-0137-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0864-2020·2020-02-05

    Radiometer AQURE basic system software recall for patient data mix-up risk

    Radiometer Medical ApS is recalling AQURE basic system software versions 2.3.5 and below due to a potential patient data mix-up risk when connected to third-party devices.

    Product
    AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0886-2020·2020-02-05

    Haemonetics Recalls CS5/5+ Bowl Kits Due to Potential Leaks

    Haemonetics is recalling CS5/5+ Bowl Kits because potential leaks may trap fluid, causing device errors and incomplete washing.

    Product
    CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0894-2020·2020-02-05

    Haemonetics Recalls CS Elite Fastpack Autotransfusion Devices Due to Leak Risk

    Haemonetics is recalling CS Elite Fastpack autotransfusion devices because cracks in the bowl core may cause leaks and incomplete blood washing.

    Product
    CS Elite Fastpack, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0867-2020·2020-02-05

    Johnson & Johnson Recalls Healon GV PRO Ophthalmic Viscosurgical Devices

    Johnson & Johnson is recalling Healon GV PRO ophthalmic viscosurgical devices because they may be difficult to remove from the eye, potentially causing increased pressure or equipment clogging.

    Product
    Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0902-2020·2020-02-05

    Haemonetics Recalls Cell Saver Elite Fastpacks Due to Potential Bowl Cracks

    Haemonetics is recalling Cell Saver Elite Fastpacks because cracks in the bowl core may cause fluid trapping and incomplete blood washing.

    Product
    JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0920-2020·2020-02-05

    Mindray BA-800M Chemistry Analyzer Recalled for Gas Spring Failure Risk

    Mindray is recalling seven BA-800M Chemistry Analyzers because a gas spring on the protective cover may fail, posing a low risk of impact injury to users.

    Product
    BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0561-2020·2020-02-05

    Essential Everyday Unbleached Flour Recalled Due to Salmonella Contamination

    UNFI General Corporate is recalling Essential Everyday Unbleached Flour after the product tested positive for Salmonella. The recall involves 1,440 bags distributed to one consignee.

    Product
    Essential Everyday, Unbleached Flour, Enriched All-Purpose Pre-Sifted, packaged in a 5lb paper bag
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0861-2020·2020-02-05

    Vitreq 27G Blunt Needles Recalled for Potential Sterility Compromise

    Vitreq Bv is recalling VitreQ 27G Blunt Needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:8719214221669
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0848-2020·2020-02-05

    Vitreq 20G Needles Recalled for Potential Sterility Compromise

    Vitreq Bv is recalling VitreQ 20G Blunt and Brush Needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF Brush Needles-REF: BF20.D52 GTIN: 8719214221102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0922-2020·2020-02-05

    Roche Cobas infinity Software Recalled for Incorrect Alarm Mapping

    Roche Diagnostics is recalling 20 Cobas infinity software modules due to incorrect alarm mapping. The software versions 2.4.1 through 2.5.4 are affected.

    Product
    Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2020·2020-02-05

    Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk

    Haemonetics is recalling Cell Saver bowl sets because cracks in the inner core may cause leaks and incomplete blood washing.

    Product
    JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and was
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2020·2020-02-05

    Haemonetics Recalls Cell Saver 5/5+ Bowl Kits Due to Leak Risk

    Haemonetics is recalling Cell Saver 5/5+ Bowl Kits because they may leak, trapping fluid and causing incomplete washing.

    Product
    Cell Saver¿5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0897-2020·2020-02-05

    Haemonetics Recalls Cell Saver 5/5+ and Elite Bowl Sets Due to Leak Risk

    Haemonetics is recalling Cell Saver 5/5+ and Elite bowl sets because potential leaks may trap fluid, causing incomplete washing of recovered blood.

    Product
    JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and was
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2020·2020-02-05

    Zimmer Biomet Recalls ASI 2.0 Calcar Trimmer Shafts Due to Mating Failure

    Zimmer Biomet is recalling 67 units of ASI 2.0 Calcar Trimmer Shafts because the shaft end may fail to mate effectively with the broach.

    Product
    ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0847-2020·2020-02-05

    Vitreq 25G Blunt and Brush Needles Recalled for Sterility Risk

    Vitreq Bv is recalling VitreQ 25G Blunt and Brush Needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    (1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-BF25.D52 GTIN: 8719214221188
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2020·2020-02-05

    Haemonetics Recalls CS Elite Processing Sets Due to Potential Bowl Cracks

    Haemonetics is recalling CS Elite Processing Sets (125 ml) because cracks in the bowl core may cause fluid trapping and incomplete blood washing.

    Product
    CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2020·2020-02-05

    Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk

    Haemonetics is recalling specific Cell Saver bowl sets because they may leak, potentially trapping fluid and causing incomplete washing.

    Product
    Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2020·2020-02-05

    Energetiq EQ-400 Light Source Recalled for Safety Interlock Failure

    Energetiq Technology is recalling 15 EQ-400 light sources because a safety interlock may fail to shut down the system if the laser collimator is removed.

    Product
    EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband light source emitting incoherent non-laser light from the Deep UV through the visible wavelengths.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0896-2020·2020-02-05

    Haemonetics Recalls CS Elite Fastpack Autotransfusion Devices Due to Leak Risk

    Haemonetics is recalling CS Elite Fastpack autotransfusion devices because cracks in the bowl core may cause leaks and incomplete washing.

    Product
    CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0853-2020·2020-02-05

    Vitreq Recalls VitreQ 27G Cannulas Due to Sterility Concerns

    Vitreq Bv is recalling VitreQ 27G VFI Cannulas because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0887-2020·2020-02-05

    Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk

    Haemonetics is recalling Cell Saver 5/5+ and Elite bowl sets because they may leak, trapping fluid and causing incomplete washing.

    Product
    High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0855-2020·2020-02-05

    Vitreq Recalls VitreQ 23G Silicone Tipped Cannula Due to Sterility Concerns

    Vitreq Bv is recalling VitreQ 23G Silicone Tipped Cannulas because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0860-2020·2020-02-05

    Vitreq Bv Recalls VitreQ 25G Blunt Needles Due to Sterility Concerns

    Vitreq Bv is recalling VitreQ 25G Blunt Needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719214221645
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2020·2020-02-05

    Vitreq Bv Recalls VitreQ 25G Pick Needles Due to Sterility Concerns

    Vitreq Bv is recalling VitreQ 25G Pick Needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0573-2020·2020-02-05

    Kindroot Adaptogems Lozenges Recalled for Undeclared Fish Allergen

    Kindroot LLC is recalling Peach Blossom plant lozenges because the label failed to list fish as the source of collagen peptides.

    Product
    kindroot adaptogems; Peach Blossom Plant lozenges for lit looks. 20 lozenges net wt. 2.6 oz. 74 g - Dietary Supplement UPC: 8 60000 30544 0 Ingredients: Marine collagen Peptides, Ashwagandha Root Extract (organic). Other ingredients: Organic Brown Rice Syrup, malic a
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0918-2020·2020-02-05

    ROi CPS Recalls Custom Procedure Packs Containing Recalled Clearlink Devices

    ROi CPS LLC is recalling 412 custom procedure packs containing Clearlink Continu-Flo devices that were previously recalled by Baxter Healthcare Corporation.

    Product
    Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B - M
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0903-2020·2020-02-05

    Haemonetics Recalls Cell Saver Elite Sets Due to Potential Bowl Leaks

    Haemonetics is recalling Cell Saver Elite sets because potential leaks in the bowl core may cause fluid trapping and incomplete washing.

    Product
    JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0917-2020·2020-02-05

    Bard Conquest 40 PTA Dilation Catheter Recalled for Packaging Error

    Bard Peripheral Vascular Inc. is recalling 286 units of Conquest 40 PTA Dilation Catheters because packaging incorrectly listed the balloon size, posing a risk of vessel injury.

    Product
    Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire .035"; Recommended Introducer 6F; Nominal Pressure 8atm, Rated Burst Pressure 40atm; Syringe inflation 1cc; UDI: (01)00801741060533(17)220228(10)REDQ3444
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0914-2020·2020-02-05

    Beckman Coulter iQ200 Urine Analyzer Recalled for Duplicate Specimen ID Errors

    Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers because they may report duplicate Specimen IDs with different patient results.

    Product
    iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis pro
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0846-2020·2020-02-05

    Vitreq 23G Needles Recalled for Potential Sterility Compromise

    Vitreq Bv is recalling VitreQ 23G needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    (1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#: 8719214221140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2020·2020-02-05

    RayStation Treatment Planning Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation software due to defects that may cause incorrect dose calculations during treatment planning.

    Product
    RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0854-2020·2020-02-05

    Vitreq Recalls VitreQ 20G VFI Cannulas Due to Sterility Concerns

    Vitreq Bv is recalling VitreQ 20G VFI Cannulas because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2020·2020-02-05

    LivaNova Recalls Cyberonics VNS Therapy AspireSR Generators for Battery Depletion

    LivaNova is recalling 745 Cyberonics VNS Therapy AspireSR Model 106 generators due to electrical leakage causing premature battery depletion.

    Product
    Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0888-2020·2020-02-05

    Haemonetics Recalls Cell Saver 5/5+ Fastpacks Due to Potential Bowl Cracks

    Haemonetics is recalling Cell Saver 5/5+ Fastpacks because cracks in the bowl core may cause fluid trapping and incomplete washing.

    Product
    CS5/5+ Fastpacks, 125 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2020·2020-02-05

    Haemonetics Recalls CS5/5+ Fastpacks Due to Potential Bowl Cracks

    Haemonetics is recalling CS5/5+ Fastpacks because cracks in the bowl core may trap fluid, causing device errors and incomplete washing.

    Product
    CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0868-2020·2020-02-05

    LivaNova Recalls Cyberonics VNS Therapy AspireHC Model 105 Generators

    LivaNova USA Inc is recalling 106 Cyberonics VNS Therapy AspireHC Model 105 generators due to electrical leakage causing premature battery depletion.

    Product
    Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0901-2020·2020-02-05

    Haemonetics Recalls Cell Saver Bowl Sets Due to Potential Leaks

    Haemonetics is recalling Cell Saver bowl sets because cracks may cause leaks and incomplete blood washing.

    Product
    Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0565-2020·2020-02-05

    ASK Foods Recalls Krab Salad Due to Potential Metal Contamination

    ASK Foods Inc. is recalling 5 lb. containers of Krab Salad in Maryland because the product may contain metal pieces.

    Product
    ASK Foods Inc., KRAB SALAD, NET WT. 5 LB (2.27 kg), Plastic tub with a plastic lid,Keep Refrigerated, 2786-140
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0564-2020·2020-02-05

    Whole Foods Recalls Dark Chocolate Caramel Sea Salt Sandwich Cremes

    Whole Foods Market is recalling 365 Everyday Value Dark Chocolate Caramel Sea Salt Sandwich Cremes due to potential undeclared milk and coconut.

    Product
    365 Everyday Value Dark Chocolate Caramel Sea Salt Sandwich Cremes Net Wt 7.75 oz (220g) UPC 9948247606 Paper carton boxes sold individually
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2020·2020-02-05

    Beckman Coulter Recalls iChemVELOCITY Urine Chemistry Systems Due to Data Errors

    Beckman Coulter is recalling iChemVELOCITY Urine Chemistry Systems because they may report duplicate specimen IDs with conflicting patient data and results.

    Product
    iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry analysis profile using iChem¿ VELOCITY Urine Chemistry Strips.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0852-2020·2020-02-05

    Vitreq Recalls VitreQ 25G VFI Cannulas Due to Sterility Concerns

    Vitreq Bv is recalling VitreQ 25G VFI Cannulas because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0857-2020·2020-02-05

    Vitreq Bv Recalls VitreQ 23G Pick Needles Due to Sterility Concerns

    Vitreq Bv is recalling VitreQ 23G Pick Needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2020·2020-02-05

    Haemonetics Recalls Cell Saver Fastpacks Due to Potential Bowl Cracks

    Haemonetics is recalling 8,641 Cell Saver 5/5+ Fastpacks because cracks in the bowl core can trap fluid, causing incomplete washing and device errors.

    Product
    CS5/5+ Fastpacks, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0588-2020·2020-02-05

    Frozen Yellowfin Tuna Recalled Due to Elevated Histamine Levels

    Truong Phu Xanh Co. is recalling frozen yellowfin tuna products from Vietnam due to elevated histamine levels. The recall affects multiple brands and cuts distributed to four states.

    Product
    Frozen Yellowfin Tuna, Product of Vietnam, Packaged under the following brands and cuts: Tidal Seafood Tuna Round Steak, size 6 - 8 oz, Size 8 - 10 oz, pack 2X10 lbs; and Sea Mart PREMIUM FROZEN YELLOWFIN TUNA LOINS 5-8 LBS IVP, 30 LBS; Sea Mart GRADE AAA FROZEN YELLOWFI
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0904-2020·2020-02-05

    Haemonetics Recalls Cell Saver Elite Sets Due to Potential Bowl Cracks

    Haemonetics is recalling Cell Saver Elite sets because cracks in the bowl core may trap fluid, causing incomplete washing of recovered blood.

    Product
    JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0889-2020·2020-02-05

    Haemonetics Recalls Cell Saver 5/5+ Fastpacks Due to Potential Leaks

    Haemonetics is recalling 1,340 units of Cell Saver 5/5+ Fastpacks because potential leaks in the inner core may cause fluid trapping and incomplete washing.

    Product
    CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0895-2020·2020-02-05

    Haemonetics Recalls CS Elite Fastpack Autotransfusion Devices Due to Leak Risk

    Haemonetics is recalling CS Elite Fastpack autotransfusion devices because cracks in the bowl core may cause leaks and incomplete blood washing.

    Product
    CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0863-2020·2020-02-05

    Custom Healthcare Systems Recalls Inpatient Dialysis Kits Due to Latex

    Custom Healthcare Systems is recalling 240 inpatient dialysis kits because a component contains latex that was not listed on the product labels.

    Product
    Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0921-2020·2020-02-05

    Mindray ABS800 Chemistry Analyzer Gas Spring Recall

    Mindray is recalling six ABS800 Chemistry Analyzers due to a potential gas spring failure that poses a low risk of impact injury to users.

    Product
    ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0899-2020·2020-02-05

    Haemonetics Recalls Japan Disp Sets Due to Potential Bowl Cracks

    Haemonetics is recalling specific Japan Disp Sets for Cell Saver systems due to potential bowl cracks that may cause leaks and incomplete blood washing.

    Product
    JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0900-2020·2020-02-05

    Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk

    Haemonetics is recalling 739 Cell Saver bowl sets because cracks in the inner core can cause leaks and incomplete blood washing.

    Product
    JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0814-2020·2020-02-05

    Sildenafil 200 mg Troche Recall for Labeling and Expiry Issues

    Sildenafil 200 mg Troche is recalled for incorrect labeling and being compounded with expired components. Consumers in Texas should check their bottles and contact the manufacturer for instructions.

    Product
    Sildenafil 200 mg Troche (Clinic)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0906-2020·2020-02-05

    Haemonetics Recalls Japan DISP SETs Due to Potential Bowl Cracks

    Haemonetics is recalling 1,584 Japan DISP SETs because cracks in the bowl core may cause leaks and incomplete washing.

    Product
    Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0569-2020·2020-02-05

    Knotts Fine Foods Recalls Tuna Salad for Possible Listeria

    Knotts Fine Foods is recalling 5lb buckets of Tuna Salad due to possible Listeria monocytogenes contamination in egg ingredients.

    Product
    5lb plastic bucket of Tuna Salad Sold as 2 - 5lb buckets per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0849-2020·2020-02-05

    Vitreq Recalls VitreQ 23G Injection Needles Due to Sterility Concerns

    Vitreq Bv is recalling VitreQ 23G PFC Injection Needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0892-2020·2020-02-05

    Haemonetics Recalls CS Elite Processing Sets Due to Potential Bowl Cracks

    Haemonetics is recalling CS Elite Processing Sets because cracks in the bowl core may cause fluid trapping and incomplete washing.

    Product
    CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0850-2020·2020-02-05

    Vitreq Recalls VitreQ 25G Injection Needles Due to Sterility Concerns

    Vitreq Bv is recalling VitreQ 25G PFC Injection Needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0820-2020·2020-02-05

    MPRX Recalls Testosterone Topical Cream 4% Due to Expired Components

    MPRX, Inc. dba Medical Park Pharmacy is recalling Testosterone Topical Cream 4% because it was compounded using expired components and has incorrect or missing lot and expiration dates.

    Product
    Testosterone Topical Cream 4%
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0881-2020·2020-02-05

    Synthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect

    Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the inner cap may open or the tube may remain in the outer cap, preventing screw removal.

    Product
    2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0845-2020·2020-02-05

    Intuitive da Vinci SP Surgical System Cannula Mount Button Recall

    Intuitive Surgical is recalling five da Vinci SP surgical systems because the cannula mount button may be damaged if released abruptly.

    Product
    The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary function is to support the positioning of the surgical port (c
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0821-2020·2020-02-05

    McGuff Compounding Pharmacy Recalls DMPS Injection Due to Particulate Matter

    McGuff Compounding Pharmacy Services, Inc. is recalling Dimercaptopropanesulfonate Sodium (DMPS) injection vials due to the presence of particulate matter.

    Product
    Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc. Santa Ana, CA 92704
    Category
    Drug
    Distribution
    19 states
  • ModerateFDA (Drugs)·D-0813-2020·2020-02-05

    Progesterone E4M SR 100 mg capsules recalled for expired components

    MPRX, Inc. is recalling specific lots of compounded Progesterone E4M SR 100 mg capsules because they were made with expired components and have incorrect labeling.

    Product
    Progesterone E4M SR 100 mg capsules
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0817-2020·2020-02-05

    Medical Park Pharmacy Recalls T3/T4 SR Capsules Due to Labeling Errors

    MPRX, Inc. dba Medical Park Pharmacy is recalling T3/T4 SR 9 mcg/38 mcg capsules due to incorrect or missing lot and expiration dates and the use of expired components.

    Product
    T3/T4 SR 9 mcg/38 mcg capsule
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0859-2020·2020-02-05

    Vitreq Bv Recalls VitreQ 23G Blunt Needles Due to Sterility Risk

    Vitreq Bv is recalling VitreQ 23G Blunt Needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719214221621
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0824-2020·2020-02-05

    FDA Recalls Nystatin Oral Suspension for Subpotent Assay Levels

    Pharmaceutical Associates Inc. is recalling Nystatin Oral Suspension because it failed potency testing at 12 months. Patients should stop using the product and consult their healthcare provider.

    Product
    NYSTATIN — NYSTATIN (NYSTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0809-2020·2020-02-05

    MPRX Recalls Magic Bullet Supplement Due to Expired Components

    MPRX, Inc. is recalling Magic Bullet Supplement bottles compounded with expired components and incorrect labeling. The recall affects products distributed in Texas.

    Product
    Magic Bullet Supplement
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0910-2020·2020-02-05

    Collagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions

    Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane Extended because they may have been packaged with incorrect Instructions for Use.

    Product
    GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; locali
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0878-2020·2020-02-05

    Smith & Nephew Recalls Legion AP Cutting Blocks Due to Design Defect

    Smith & Nephew is recalling specific lots of LEGION AP Cutting Blocks because they were manufactured with an oversize green plunger hole, failing to meet design specifications.

    Product
    LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical instrument).
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0919-2020·2020-02-05

    Arthrex Fibulock Fibular Nail Instrument Set Recalled for Potential Blockage

    Arthrex, Inc. is recalling 47 units of the Fibulock Fibular Nail Instrument Set due to a potential for blockage of the Hub Attachment Tube.

    Product
    Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0909-2020·2020-02-05

    Collagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions

    Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane 6-9 because they may have been packaged with incorrect Instructions for Use.

    Product
    GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized rid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0875-2020·2020-02-05

    GE Healthcare Recalls SIGNA Architect MRI Systems Due to Date Errors

    GE Healthcare is recalling SIGNA Architect MRI systems because a potential installation issue may cause incorrect dates to be recorded on medical images.

    Product
    SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0882-2020·2020-02-05

    Synthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect

    Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the inner packaging cap may open or fail to separate, potentially delaying surgery.

    Product
    2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0865-2020·2020-02-05

    Medline VP Tray Recall Due to Potential Sterile Barrier Compromise

    Medline Industries is recalling 500 units of DYNDA1928 VP Trays because the sterile wrap may become loose in transit, compromising the sterile barrier.

    Product
    Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10)0000000000 (17)000000(30)20 Packaged for Medline Industries, Inc., Northfield, IL 60093 USA. 1-800-MEDLINE www.medline.com WINGED SPONGE:M
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0571-2020·2020-02-05

    Healthy Food Ingredients Recalls Organic Flaxseed Due to Unapproved Herbicide

    Healthy Food Ingredients, LLC is recalling Organic IntegriPure Cold Milled Flaxseed in 50 lb and 2,000 lb totes due to the detection of an unapproved herbicide.

    Product
    Organic IntegriPure Cold Milled Flaxseed, 50 lb Net Wt. and 2000 lb. totes
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0912-2020·2020-02-05

    GIBSON Healthcare Membrane Extended Recalled for Incorrect Instructions for Use

    Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane Extended because they may have been packaged with incorrect Instructions for Use.

    Product
    GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localize
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0874-2020·2020-02-05

    GE Healthcare Recalls SIGNA Premier MRI Systems Due to Date Errors

    GE Healthcare is recalling 62 SIGNA Premier MRI systems because a potential installation issue could cause incorrect dates to be recorded on medical images.

    Product
    SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0880-2020·2020-02-05

    Synthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect

    Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the packaging may fail to keep the screw sealed, potentially causing surgical delays.

    Product
    2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0879-2020·2020-02-05

    Synthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect

    Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the packaging may fail to keep the screw accessible, potentially delaying surgery.

    Product
    2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0877-2020·2020-02-05

    GE Healthcare Recalls MRI Systems Due to Potential Date Setting Error

    GE Healthcare is recalling 62 MRI systems because a potential installation issue may cause incorrect dates to be recorded on medical images.

    Product
    SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0908-2020·2020-02-05

    GIBSON Healthcare Membrane Recalled for Incorrect Instructions for Use

    Collagen Matrix Inc is recalling GIBSON Healthcare Membrane 6-9 units because they may have been packaged with incorrect Instructions for Use.

    Product
    GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized rid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0907-2020·2020-02-05

    Collagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions

    Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane 6-9 because they may have been packaged with incorrect Instructions for Use.

    Product
    GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized rid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0808-2020·2020-02-05

    Medical Park Pharmacy Recalls Liothyronine Due to Expired Components

    MPRX, Inc. dba Medical Park Pharmacy is recalling Liothyronine (T3) 92.5 MCG compounded with expired components due to incorrect or missing lot and expiration dates.

    Product
    Liothyronine (T3) 92.5 MCG
    Category
    Drug
    Distribution
    1 state

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