The Recall Desk

Archive

March 2020 recalls

515 recalls were announced in March 2020.

What the numbers show

Critical
16
Severe
165
High
214
Moderate
96
Low
24

Of the 515 recalls this month scored against our rubric, 3% are Critical, 32% are Severe.

401–500 of 515

  • CriticalFDA (Food)·F-0756-2020·2020-03-04

    Nopalina Flax Seed Fiber Capsules Recalled for Salmonella Contamination

    Salud Natural Entrepreneur, Inc. is recalling Nopalina Flax Seed Fiber Capsules because FDA testing found Salmonella in the senna leaves powder ingredient.

    Product
    Nopalina Flax Seed Fiber Capsules, 120 count bottle, UPC 8 90523 00086 7
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0755-2020·2020-03-04

    Nopalina Flax Seed Fiber Recalled for Salmonella Contamination

    Salud Natural Entrepreneur, Inc. is recalling Nopalina Flax Seed Fiber powder in 1 and 2 lb bags because FDA testing found Salmonella in the senna leaves powder ingredient.

    Product
    Nopalina Flax Seed Fiber in 1 and 2 lb bags, UPC 8 90523 00072 0 and 8 90523 00084 3
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0798-2020·2020-03-04

    Bakkavor Mushroom Barley Soup Recalled for Undeclared Milk Allergen

    Bakkavor Foods USA Inc. is recalling Chef's Recipe Mushroom Barley Soup because it contains undeclared milk. Consumers with milk allergies should not consume the product.

    Product
    chef's recipe MUSHROOM BARLEY SOUP NET WT 16 OZ (1LB) 454g PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105 UPC 1 61088 80363 0
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1346-2020·2020-03-04

    Siemens COHERENCE Oncologist Software Recall for Incorrect Dose Positioning

    Siemens is recalling COHERENCE Oncologist software due to a calculation error that could lead to incorrect patient repositioning and radiation dose delivery to the wrong location.

    Product
    COHERENCE Oncologist, Model Nos. 07333680 & 07351898
    Category
    Medical Device
    Distribution
    16 states
  • SevereNHTSA·20V132000·2020-03-04

    Peterbilt 320 and 520 Trucks Recalled for Brake Signal Hose Defect

    PACCAR is recalling 2016-2020 Peterbilt 320 and 520 trucks because a missing quick release valve may delay brake release, increasing crash risk.

    Product
    PETERBILT — PETERBILT 320, 520
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V130000·2020-03-04

    Peterbilt Trucks Recalled for Battery Cable Fire Risk

    PACCAR is recalling 2015-2020 Peterbilt trucks because a battery cable may chafe and cause an electrical short circuit, increasing fire risk.

    Product
    PETERBILT — PETERBILT 579, 365, 389, 567
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V131000·2020-03-04

    AEV Traumahawk Ambulances Recalled for Electrical Fire Risk

    Halcore Group is recalling 2018 AEV Traumahawk ambulances because an undersized power cord may cause an electrical short circuit, increasing the risk of fire or shock.

    Product
    AEV — AEV TRAUMAHAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0737-2020·2020-03-04

    El Milagro Corn Tortillas Recalled for Potential Metal Inclusion

    El Milagro of Texas Inc. is recalling 2,400 packages of Original Corn/Maiz tortillas due to potential metal inclusion. The products were distributed in Texas.

    Product
    Original El Milagro Corn/Maiz tortillas 30 count Net Wt. 26 Oz. (750g) Refrigerate After Purchase UPC 649619621178
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1358-2020·2020-03-04

    Medline Robotic-LF Complete Delivery System Recall Due to Sterility Concerns

    Medline Industries is recalling 122 units of the Robotic-LF Complete Delivery System because the sterile packs did not complete a sterilization cycle, meaning sterility cannot be guaranteed.

    Product
    Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1357-2020·2020-03-04

    Medline Lumbar Delivery System Recalled Due to Sterilization Failure

    Medline Industries is recalling 122 units of HOI Lumbar Complete Delivery Systems because the sterile packs did not complete a sterilization cycle, compromising sterility.

    Product
    Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1402-2020·2020-03-04

    MicroVention HydroFrame 10 Embolic Coils Recalled for Missing Implant Coil

    MicroVention is recalling 991 HydroFrame 10 and HydroCoil embolic systems because the implant coil may be missing. The devices were distributed outside the United States.

    Product
    MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 100306HFRM-V, 100405HFRM-V, 100408HFRM-V, 100410HFRM-V, 100412HFRM-V, 100415HFRM-V, 100510HFRM-V, 100515HFRM-V, 100519HFRM-V, 100612HFRM-V, 100619HFRM-V, 100623HF
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1400-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF numbers 100204CC-V, 100307CC-V, 100410CC-V, 100512CC-V, 100615CC-V, 100718CC-V, 100820CC-V, 100924CC-V, and 101026CC-V. Product Usage: The MCS is also intended
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1405-2020·2020-03-04

    MicroVention HydroSoft Embolization Coils Recalled for Missing Implant Coils

    MicroVention is recalling 847 HydroSoft embolization coils because the implant coil may be missing from the packaging. The devices were distributed to 43 countries outside the United States.

    Product
    MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, 100206HFRM-V, 100208HFRM-V, 100254HFRM-V, 100256HFRM-V, 100308HFRM-V, MV-00202
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1370-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA354
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V128000·2020-03-04

    Horton Ambulances Recalled for Electrical Short Circuit Risk

    Halcore Group is recalling 2016-2019 Horton Type I and III ambulances because an undersized A/C power cord may cause an electrical short circuit, increasing the risk of fire or shock.

    Product
    HORTON — HORTON TYPE I, TYPE III
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0750-2020·2020-03-04

    Domino Foods Recalls SYSCO Brown Sugar Due to Foreign Material

    Domino Foods is recalling SYSCO Classic Light Brown Cane Sugar because it may contain foreign material. The product was distributed to 23 states and Saudi Arabia.

    Product
    SYSCO Classic Light Brown Cane Sugar, 25 LB bag, UPC 074865990301, Lots 50043 (Best By Jan 22, 2022) & 50045 (Best By Jan 24, 2022)
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-1355-2020·2020-03-04

    Cook Inc. Recalls Zenith Alpha Spiral-Z Endovascular Leg Grafts

    Cook Inc. is recalling Zenith Alpha Spiral-Z Endovascular Leg grafts due to identified factors contributing to thrombus formation and lumen occlusion. The product is distributed only outside the United States.

    Product
    Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0754-2020·2020-03-04

    Lotte Choco Pie Banana Recalled for Undeclared Almond

    Lotte Choco Pie Banana is being recalled because FDA testing found undeclared almond protein. Consumers with this product should stop eating it.

    Product
    Lotte Choco Pie Banana, 12 pack, 11.85 oz. (336 g) UPC: 8 45502 06140 7 Distributed by Lotte International America, Los Angeles, CA Product of Korea Contains Wheat, soy Egg Manufactured in a facility that also processes Almond, Peanut.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1407-2020·2020-03-04

    MicroVention Platinum Coil System Recall for Missing Implant Coils

    MicroVention is recalling Microplex 10 Platinum Coil Systems because the implant coil may be missing from the packaging.

    Product
    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx, REF numbers 100101HS-V, 100102HS-V, 100103HS-V, 100104HS-V, 100151HS-V, 100152HS-V, 100153HS-V, 100154HS-V, 100201HS-V, 100202HS-V, 100203HS-V, 100204HS-V, 100
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1398-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 3,442 units of Platinum Coil Systems because the implant coil may be missing from the packaging.

    Product
    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx, REF numbers 100202CSSR-V, 100254CSSR-V, 100306CSSR-V, 100408CSSR-V, 100412CSSR-V, 100515CSSR-V, 100522CSSR-V, 100618CSSR-V, 100626CSSR-V, 100722CSSR-V, 100731CSSR-V,
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1384-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in scanned data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1397-2020·2020-03-04

    MicroVention Platinum Coil System Recall for Missing Implant Coils

    MicroVention is recalling 169 units of Microplex 18 Platinum Coil Systems because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204HC-S-V, 180208HC-S-V, 180308HC-S-V, 180410HC-S-V, and 180512HC-S-V. Product Usage: The MCS is also intended for vascular occlusion of blood v
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1381-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1403-2020·2020-03-04

    MicroVention HydroFrame 18 Embolic System Recalled for Missing Implant Coil

    MicroVention is recalling 32 units of HydroFrame 18 embolic systems because the implant coil may be missing. The devices were distributed internationally.

    Product
    MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, and MV-81036HHFA. Product Usage: The HES is also intended for vascular occlu
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1378-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0753-2020·2020-03-04

    Lotte Choco Pie Recalled for Undeclared Almond Allergen

    Lotte Choco Pie Original is being recalled because FDA testing found undeclared almond protein in the product.

    Product
    Lotte Choco Pie Original, 12 pack 11.85 oz. (336 g) UPC: 8 801062 160709 Distributed by Lotte International America, Los Angeles, CA Product of Korea Contains: Wheat, soy, Egg. Manufactured in a facility that also processes Almond, Peanut.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1356-2020·2020-03-04

    Zimmer Sterile Disposable Tourniquet Cuff Recalled for Bladder Leak

    Zimmer Surgical Inc is recalling 58 units of sterile tourniquet cuffs because a leak between bladders may cause both to inflate or deflate simultaneously.

    Product
    Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (17)230812(10)27968701 The product is a tourniquet - Product Usage: Tourniquets are intended to be used by qualified medical prof
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1343-2020·2020-03-04

    Hologic Selenia Dimensions Mammography System Recalled for C-Arm Defects

    Hologic is recalling 72 Selenia Dimensions Mammography Systems because the C-arm may seize or drop during repairs and cleaning.

    Product
    Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Food)·F-0739-2020·2020-03-04

    Lanvin French Bakery Recalls Deep-Fried Bread for Undeclared Wheat and Soybean Oil

    Lanvin French Bakery is recalling 26 bags of deep-fried bread (Banh Gio Chao Quay) in Oregon and Washington due to undeclared wheat and soybean oil.

    Product
    Deep-fried Bread (Banh Gio Chao Quay) 6-ounce package in clear plastic bag, no UPC, no brand. Product is labeled in part, "BANH GIO CHAO QUAY***Ingredients: bread flour, sugar, salt, baking powder, vegetable oil, water.***Lanvin French Bakery***".
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1392-2020·2020-03-04

    MicroVention HydroSoft 10 Embolic Coils Recalled for Missing Implant Coil

    MicroVention is recalling 2,762 units of HydroSoft 10 embolic coils because the implant coil may be missing from the packaging.

    Product
    MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2HS-V, 100103H2HS-V, 100104H2HS-V, 100151H2HS-V; 100152H2HS-V; 100153H2HS-V; 100154H2HS-V; 100201H2HS-V; 100202H2HS-V; 100203H2HS-V;
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1399-2020·2020-03-04

    MicroVention Platinum Embolization Coils Recalled for Missing Implant Coil

    MicroVention is recalling 403 units of Platinum Embolization Coils because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 180619CS-V, 180723CS-V, 180827CS-V, 180931CS-V, 181036CS-V, 181139CS-V, 181243CS-V, 181347CS-V, 181451CS-V, 181652CS-V, 181859CS-V, 182065CS-V, 182263CS-V, and 182468CS-V; Produc
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1347-2020·2020-03-04

    Zimmer Biomet Recalls THP Hip Plating System Due to Fracture Risk

    Zimmer Biomet is recalling 1,662 units of the THP Hip Plating System after internal testing detected a potential increase in fracture rate and packaging discoloration.

    Product
    THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1404-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coils

    MicroVention is recalling 85 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the packaging.

    Product
    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V, 100408CMSR-V, 100412CMSR-V, 100510CMSR-V, 100516CMSR-V, 100612CMSR-V, 100618CMSR-V, and 100721CMSR-V. Product Usage: The MCS is also inten
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0757-2020·2020-03-04

    Annie Chun's Teriyaki Noodle Bowl Recalled for Undeclared Peanuts

    CJ Foods is recalling Annie Chun's Teriyaki Noodle Bowls because they were packaged with sleeves for Pad Thai bowls, leaving peanuts undeclared on the label.

    Product
    Annie Chun's Japanese Style Teriyaki Noodle Bowl with Cooked Hokkien Noodles - Sweet & Tangy sauce with Bok choy and carrots. Noodles are in Opaque White Plastic bowl with paper sleeves. Net Wt. 7.8 oz. (221g) UPC: 7-65667-10387-6 Add 1 1/4 water and microwave on high fo
    Category
    Food
    Distribution
    10 states
  • HighFDA (Drugs)·D-0863-2020·2020-03-04

    Taro Recalls Phenytoin Oral Suspension Due to Resuspension Issues

    Taro Pharmaceuticals is recalling two lots of Phenytoin Oral Suspension because the medication may coagulate and fail to resuspend as directed.

    Product
    PHENYTOIN — PHENYTOIN (PHENYTOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0742-2020·2020-03-04

    PNW Veg Co Recalls Frozen Roasted Spicy Potatoes Due to Undeclared Allergens

    PNW Veg Co LLC is recalling frozen Roasted Spicy Potatoes O'Brien because the product contains undeclared wheat and soy.

    Product
    Foodservice item, Norpac Catalog Number 08099, frozen FLAV-R-PAC Roasted Spicy Potatoes O'brien, 6/40 oz. (2.5 lbs.) clear poly bags per case. Master Case # 100488000080997. The affected product was packaged in a clear poly bags and has no label. The affected product's m
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1351-2020·2020-03-04

    St Jude Ellipse ICD Recall for Wireless Communication Loss

    St Jude Medical is recalling 256 Ellipse ICDs because past updates may cause loss of wireless communication, preventing remote patient monitoring.

    Product
    Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1395-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention, Inc. is recalling 780 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HCSR-S-V, 100310HC-S-V, 100310HCSR-S-V, 100410HC-S-V, 100410HCSR-S-V, Product
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1406-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 666 units of Platinum Coil Systems because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC, MV-00310VFC, MV-00630VFC, VFC010303-V, VFC030606-V, VFC030610-V, VFC030615-V, VFC061020-V, VFC061030-V, VFC101530-V, VFC101540-V, VFC1520
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1350-2020·2020-03-04

    Ulrich Medical Recalls Spinal Locking Screws Due to Weld Seam Defect

    Ulrich medical USA Inc is recalling 179 units of neon3 OCT spinal stabilization locking screws because a production error prevents them from reliably transmitting required torque.

    Product
    Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1394-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 486 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular, Sterile, Rx, REF numbers 100515HC-R-V, 100515HCSR-R-V, 100520HC-R-V, 100520HCSR-R-V, 100620HC-R-V, 100620HCSR-R-V, 100730HC-R-V, 100730HCSR-R-V, 100830HC-R-V, 100930HC-R-V
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1396-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 9 units of Microplex 18 Platinum Coil Systems because the implant coil may be missing from the packaging.

    Product
    MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Regular, Sterile, Rx, REF numbers 180520HC-R-V and 181230HC-R-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1393-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 1,725 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V, 100103HS3D-V, 100152HS3D-V, 100153HS3D-V, 100154HS3D-V, 100202HS3D-V, 100203HS3D-V, 100204HS3D-V, 100206HS3D-V, 100208HS3D-V, 100254HS3D-V
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0752-2020·2020-03-04

    Lotte Choco Pie Cocao Recalled for Undeclared Almond Protein

    Lotte International America is recalling Lotte Choco Pie Cocao because FDA testing found undeclared almond protein in the product.

    Product
    Lotte Choco Pie Cocao, 12 pack, 11.85 oz. (336 g) UPC: 8 801062 475148 Distributed by Lotte International America, Los Angeles, CA Product of Korea
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0738-2020·2020-03-04

    Lanvin French Bakery Recalls Deep-Fried Donuts for Undeclared Allergens

    Lanvin French Bakery is recalling 49 bags of deep-fried donuts (Banh Tieu) distributed in Oregon and Washington due to undeclared wheat and soybean oil.

    Product
    Deep-fried Donut (Banh Tieu) 3.2-ounce package in clear plastic bag, no UPC, no brand. Product is labeled in part, "BANH TIEU***Ingredients: bread flour, sugar, baking powder, salt, sesame seed, water, shortening oil.***Lanvin French Bakery***".
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0800-2020·2020-03-04

    Coburn Farms Snackers Recalled for Undeclared Peanut Labeling Error

    Great Lakes Cheese Co Inc is recalling Coburn Farms Snackers due to a labeling error that failed to declare peanut as an ingredient.

    Product
    Coburn Farms Snackers, Sharp Yellow Cheddar Cheese, Cherry Juice Infused Dried Cranberries & Roasted Sea Salted Cashews, 3 Pack, Net Wt 4.5 oz (127.5g) 3-1.5 oz (42.5g) packs, Keep Refrigerated. UPC 51933-36243. Distributed By: Save-A-Lot Food Stores, Ltd., Earth City, MO 63
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-1369-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Misalignment

    Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation or margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1401-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 19 units of the Microplex 18 Platinum Coil System because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, 180820CC-V, 181026CC-V, 181434CC-V, and 182050CC-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within t
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1373-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1352-2020·2020-03-04

    Breas Medical Recalls Vivo Ventilator Protective Covers Due to Obstruction Risk

    Breas Medical is recalling 629 Vivo ventilator protective covers because the design may obstruct the exhalation valve control pressure tube.

    Product
    Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1342-2020·2020-03-04

    Philips Ambulance Parameter Extension Kit Recalled for ECG Signal Loss

    Philips is recalling 43 Ambulance Parameter Extension kits because they may cause ECG 'Leads Off' errors in hot, humid environments.

    Product
    Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1374-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Fit Issues

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0743-2020·2020-03-04

    Domino Foods Recalls C&H Golden Brown Sugar Due to Foreign Material

    Domino Foods Inc is recalling specific lots of C&H Pure Cane Sugar Golden Brown due to possible foreign material contamination.

    Product
    C&H Pure Cane Sugar Golden Brown, 32 oz (2 LB) plastic bag, UPC 015800090038, Lots 50042 (Best By Jan 21, 2022) & 50043 (Best By Jan 22, 2022)
    Category
    Food
    Distribution
    23 states
  • ModerateFDA (Food)·F-0778-2020·2020-03-04

    Nature's Sunshine SmartMeal Shake Mix Recalled for Unapproved Herbicide in Flax Seed

    Pro-Form Manufacturing LLC is recalling Nature's Sunshine SmartMeal Nutritional Shake Mix because the flax seed used in the product contains an unapproved herbicide.

    Product
    Nature's Sunshine SmartMeal Nutritional Shake Mix; Natural Chocolate Flavor Net Wt. 1 lb. 3.5 oz. (555 Grams) UPC: 0 99904 03084 8 Product number: 6116 US3084 Distributed exclusively by: Nature's Sunshine Products, Inc. Spanish Fork, UT 84660
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0749-2020·2020-03-04

    Domino Foods Recalls SYSCO Light Brown Cane Sugar for Foreign Material

    Domino Foods Inc is recalling specific lots of SYSCO Classic Light Brown Cane Sugar due to possible foreign material. The product was distributed to 23 states and Saudi Arabia.

    Product
    SYSCO Classic Light Brown Cane Sugar, 32 oz (2 LB) plastic bag, UPC 074865755368, Lots 50042 (Best By Jan 21, 2022) & 50051 (Best By Jan 27, 2022)
    Category
    Food
    Distribution
    23 states
  • ModerateFDA (Food)·F-0744-2020·2020-03-04

    Domino Brown Sugar Recalled for Possible Foreign Material

    Domino Foods Inc is recalling specific lots of Domino Premium Pure Cane Light Brown Sugar due to possible foreign material.

    Product
    Domino Premium Pure Cane Light Brown Sugar, 16 oz (1 LB) box, UPC 049200056752, Lots 50045 (Best By Jan 24, 2022) & 50046 (Best By Jan 25, 2022)
    Category
    Food
    Distribution
    23 states
  • ModerateFDA (Food)·F-0790-2020·2020-03-04

    Paleonola Grain Free Granola Recalled for Unapproved Herbicide Contamination

    Paleonola Llc is recalling Paleonola Grain Free Granola in Pina Colada flavor due to potential contamination with the unapproved herbicide haloxyfop.

    Product
    Paleonola Grain Free Granola; Pina Colada; packaged in 10oz stand-up pouches; UPC 091037367808
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1387-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1364-2020·2020-03-04

    Exactech Recalls Truliant Splined Stem Extensions Due to Labeling Error

    Exactech is recalling four Truliant Splined Stem Extensions because the labels incorrectly identify the implant size as 17mm x 80mm instead of 18mm x 120mm.

    Product
    Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1366-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1376-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i, LLC is recalling specific lots of Bellatek Encode Healing Abutments because they may produce incorrect rotation or margin contour misalignment in scanned data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0784-2020·2020-03-04

    Lifetime Fitness D. Tox Shake Mix Recalled for Unapproved Herbicide

    Pro-Form Manufacturing LLC is recalling Lifetime Fitness D. Tox Shake Mix because the flax seed used in the product contains an unapproved herbicide.

    Product
    Lifetime Fitness D. Tox Shake Mix; Plant-Based Protein Blend. Dietary Supplement - Net Wt. 2.50 lb. (40 oz.) 1.13 kg One gallon White HDPE Jar Natural Chocolate Flavor UPC: 6 82471 00830-5 Product number: 6142-2644 Manufactured exclusively for: Life Time Fitness Inc.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0747-2020·2020-03-04

    Domino Foods Recalls Great Value Light Brown Sugar for Foreign Material

    Domino Foods Inc is recalling Great Value Light Brown Sugar, 32 oz, due to possible foreign material. The product was distributed to 23 states and Saudi Arabia.

    Product
    Great Value Light Brown Sugar, 32 oz (2 LB) plastic bag, UPC 078742372211, Lots 50043 (Best By Jan 22, 2022), 50044 (Best By Jan 23, 2022), 50045 (Best By Jan 24, 2022), 50046 (Best By Jan 25, 2022), 50047 (Best By Jan 26, 2022)
    Category
    Food
    Distribution
    23 states
  • ModerateFDA (Food)·F-0788-2020·2020-03-04

    Paleonola Grain Free Granola Recalled for Unapproved Herbicide Contamination

    Paleonola Llc is recalling 7,388 cases of Grain Free Granola due to potential contamination with the unapproved herbicide haloxyfop.

    Product
    Paleonola Grain Free Granola; The Original; packaged in 10oz stand-up pouches; UPC 013964497144
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-0780-2020·2020-03-04

    Nature's Sunshine CMapt M SmartMeal Recalled for Unapproved Herbicide in Flax Seed

    Pro-Form Manufacturing LLC is recalling Nature's Sunshine CMapt M SmartMeal products because the flax seed used contains an unapproved herbicide.

    Product
    Nature's Sunshine CMapt M - Cmapt Mi- SmartMeal; Bahu bhbhi - Vanilla; 510 g UPC: 0 99904 03085 5 Product number: 6116-RU3085 6116-UA3085 Distributed in Russia and Ukraine - same label Nature's Sunshine Products Inc. 2500 West Executive Pa
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0782-2020·2020-03-04

    Nature's Sunshine SmartMeal Shake Mix Recalled for Unapproved Herbicide

    Pro-Form Manufacturing LLC is recalling Nature's Sunshine SmartMeal Nutritional Shake Mix because the flax seed ingredient contains an unapproved herbicide.

    Product
    Nature's Sunshine SmartMeal Nutritional Shake Mix; Natural Vanilla Flavor Net Wt. 1 lb. 2 oz. (510 g) UPC: 0 99904 03085 5 Product number: 6116-US3085 Distributed by: Nature's Sunshine Products Inc. 1655 North Main Spanish Fork, UT 84660
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0748-2020·2020-03-04

    Domino Foods Recalls HY-VEE Brown Sugar Due to Foreign Material

    Domino Foods Inc is recalling specific lots of HY-VEE Pure Cane Light Brown Sugar due to a possible foreign material hazard.

    Product
    HY-VEE Pure Cane Light Brown Sugar, 32 oz (2 LB) plastic bag, UPC 075450055177, Lots 50043 (Best By Jan 22, 2022) & 50044 (Best By Jan 23, 2022)
    Category
    Food
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-1368-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference Number: IEHA346
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0792-2020·2020-03-04

    Paleonola Grain Free Granola Recalled for Unapproved Herbicide Contamination

    Paleonola Llc is recalling 7,388 cases of Grain Free Granola; Apple Pie due to potential contamination with the unapproved herbicide haloxyfop.

    Product
    Paleonola Grain Free Granola; Apple Pie; packaged in 10oz stand-up pouches; UPC 013964497106
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-0783-2020·2020-03-04

    Lifetime Fitness D. Tox Shake Mix Recalled for Unapproved Herbicide

    Pro-Form Manufacturing LLC is recalling Lifetime Fitness D. Tox Shake Mix because the flax seed used in the product contains an unapproved herbicide.

    Product
    Lifetime Fitness D. Tox Shake Mix; Plant-Based Protein Blend. Dietary Supplement - Net Wt. 2.36 lb. (37.76 oz.) 1.07 kg Program Kit - Natural Vanilla Flavor UPC: 6 82471 00831-2 Product number: 6142-2646 Manufactured exclusively for: Life Time Fitness Inc. 2902 Corpor
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1365-2020·2020-03-04

    bioMerieux Recalls NUCLISENS Lysis Buffer Due to pH Electrode Dysfunction

    bioMerieux is recalling NUCLISENS Lysis Buffer, Lot 19040201, because pH electrode dysfunction caused colored eluates and invalid test results.

    Product
    NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280 Marcy-l'Etoile - France - Product Usage: to be used for the release of total nucleic acid from biological specimens.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1388-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1375-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1345-2020·2020-03-04

    Philips DigiTrak XT Holter Recorder Software Recall for Malfunction

    Philips is recalling DigiTrak XT Holter Recorders because a software defect causes the device to fail when an AAA battery is present.

    Product
    Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as follows: - 453564067151 24-Hour Configuration - 453564067161 48-Hour Config
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1363-2020·2020-03-04

    Siemens ADVIA Chemistry Lipase Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Lipase reagents due to customer complaints about failed calibrations and increased imprecision in quality control and patient samples.

    Product
    ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas, such as acute pancreatitis and obstruction of the pancreatic duct.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1382-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0751-2020·2020-03-04

    Losurdo Foods Recalls Fresh Mozzarella Products Due to Employee Illness

    Losurdo Foods is recalling three fresh mozzarella products as a precaution because a production employee was diagnosed with food poisoning after handling the items.

    Product
    1. Boars Head Fresh Mozzarella Ball, 8oz. 2. Losurdo Fresh Caprese Log Mozzarella, 6 lbs. 3. Piancone Fresh Mozzarella Loaf, 3 lbs. and 6 lbs.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0746-2020·2020-03-04

    Domino Brown Sugar Recalled for Possible Foreign Material

    Domino Foods Inc is recalling 50 LB bags of Premium Pure Cane Medium Brown Sugar due to possible foreign material.

    Product
    Domino Premium Pure Cane Medium Brown Sugar, 50 LB bag, UPC 049200009727, Lots 50044 (Best By Jan 23, 2022) & 50045 (Best By Jan 24, 2022)
    Category
    Food
    Distribution
    23 states
  • ModerateFDA (Food)·F-0779-2020·2020-03-04

    Nature's Sunshine NutriSmart Vanilla Powder Recalled for Unapproved Herbicide

    Pro-Form Manufacturing LLC is recalling Nature's Sunshine NutriSmart Vanilla Powder because the flax seed ingredient contains an unapproved herbicide.

    Product
    Nature's Sunshine NutriSmart Polvo Para Preparar Bebida Sabor Vainilla Con In Toque Sabor a Chocolate; Vainilla Flavor Contenido Neto 510 g UPC: 0 99904 61532 8 Product number: 6116-MX61532 Importado y Distribuido por: Nature's Sunshine Products de Mexico, S.A. de C. V.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0793-2020·2020-03-04

    Paleonola Grain Free Granola Recalled for Unapproved Herbicide Contamination

    Paleonola Llc is recalling 7,388 cases of Grain Free Granola; Pumpkin Pie due to potential contamination with the unapproved herbicide haloxyfop.

    Product
    Paleonola Grain Free Granola; Pumpkin Pie; packaged in 10oz stand-up pouches; UPC 013964497137
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-0789-2020·2020-03-04

    Paleonola Grain Free Granola Recalled for Unapproved Herbicide Contamination

    Paleonola Llc is recalling Grain Free Granola and Maple Pancake products due to potential contamination with the unapproved herbicide haloxyfop.

    Product
    Paleonola Grain Free Granola; Maple Pancake; packaged in 10oz stand-up pouches; UPC 013964497120
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1371-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Misalignment

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0791-2020·2020-03-04

    Paleonola Grain Free Granola Recalled for Unapproved Herbicide Contamination

    Paleonola Llc is recalling 7,388 cases of Grain Free Granola (Chocolate Fix) because it may be contaminated with the unapproved herbicide haloxyfop.

    Product
    Paleonola Grain Free Granola; Chocolate Fix; packaged in 10oz stand-up pouches; UPC 013964497113
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-0758-2020·2020-03-04

    Sierra Soups Pasta e Fagioli Recalled for Misleading Gluten-Free Labeling

    Sierra Soups is recalling 2,868 packages of Pasta e Fagioli soup because the product contains wheat pasta but is labeled as gluten-free.

    Product
    Sierra Soups Pasta e Fagioli: All Natural Vegetarian Vegan (without pasta); Gluten Free (without pasta); Net Wt. 369 g , 13 oz. Packed in clear plastic bag. Pasta is contained in a separate plastic bag inside the package. Product of USA Sierra Foods Company, Fresno, CA
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1380-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1349-2020·2020-03-04

    Randox RX Daytona Plus Clinical Chemistry Analyzer Software Recall

    Randox Laboratories is recalling RX Daytona Plus clinical chemistry analyzers to fix software issues causing incorrect sample ordering and quality control flags.

    Product
    RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1385-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in scanned data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1377-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1379-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because the resulting impression or scanned data may cause incorrect rotation and margin contour misalignment.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA464
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1386-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour misalignment in scanned data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0745-2020·2020-03-04

    Domino Brown Sugar Recalled for Possible Foreign Material

    Domino Foods Inc is recalling 50 LB bags of Premium Pure Cane Golden Light Brown Sugar due to possible foreign material.

    Product
    Domino Premium Pure Cane Golden Light Brown Sugar, 50 LB bag, UPC 049200009727, Lots 50041 (Best By Jan 20, 2022), 50042 (Best By Jan 21, 2022), 50043 (Best By Jan 22, 2022)
    Category
    Food
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-1367-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Misalignment

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.

    Product
    CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0741-2020·2020-03-04

    Terra Ingredients Recalls Organic Flax Due to Haloxyfop Residue

    Terra Ingredients is recalling Organic Gold and Brown Flax due to the detection of the chemical residue Haloxyfop.

    Product
    terra ingredients - Organic Gold Flax and Organic Brown Flax, 50 pound bags & 2,000 lbs. Totes
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-0861-2020·2020-03-04

    CVS Health Sodium Chloride Ophthalmic Ointment Recalled for Particulate Matter

    Akorn, Inc. is recalling CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, due to the presence of brown spots identified as tin with trace copper inside the tubes.

    Product
    CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895, NDC 59779-303-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1354-2020·2020-03-04

    Theralase TLC-2000 Laser System Recalled for Low Power Output

    Theralase Inc. is recalling 92 TLC-2000 Therapeutic Medical Laser Systems because the 905 nm laser diodes may be below rated power output.

    Product
    TLC-2000 Therapeutic Medical Laser System
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0860-2020·2020-03-04

    Akorn Recalls Well at Walgreens Sodium Chloride Ophthalmic Ointment Due to Particulate Matter

    Akorn, Inc. is recalling specific tubes of Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, due to the presence of brown spots identified as tin with trace copper.

    Product
    Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-9050-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1390-2020·2020-03-04

    Getinge 46-Series Washer Disinfector Recalled Due to Missing Water Intake Components

    Maquet Cardiovascular is recalling four Getinge 46-Series Washer Disinfector units because they lack necessary water intake components, preventing proper installation.

    Product
    Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods
    Category
    Medical Device
    Distribution
    7 states

Looking for a different month? Back to 2020.