The Recall Desk

Archive

October 2019 recalls

807 recalls were announced in October 2019.

What the numbers show

Critical
64
Severe
328
High
307
Moderate
88
Low
20

Of the 807 recalls this month scored against our rubric, 8% are Critical, 41% are Severe.

301–400 of 807

  • HighFDA (Devices)·Z-0091-2020·2019-10-16

    Centurion Medical CVC Bundle Recall Due to Fluid Droplet Risk

    Centurion Medical Products is recalling CVC bundles containing a recalled BD connector due to potential fluid droplet separation.

    Product
    CVC BUNDLE, 20CM, 3L, PI ECVC5120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0055-2020·2019-10-16

    BD Microtainer Tubes Recalled for Damaged Reservoirs and Erroneous Test Results

    Becton Dickinson is recalling specific lots of BD Microtainer Tubes with Lithium Heparin because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

    Product
    BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V739000·2019-10-16

    Hyundai Translead Recalls 2018-2019 Dry Van Trailers for Air Hose Defect

    Hyundai Translead is recalling 2018-2019 Dry Van Trailers because a beam clip may detach, allowing air hoses to drag on the ground and potentially leak air.

    Product
    HYUNDAI TRANSLEAD — HYUNDAI TRANSLEAD DRY VAN TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0136-2020·2019-10-16

    Pfizer Recalls LMD in Dextrose Bags Due to Sterility Concerns

    Pfizer is recalling 17,832 bags of LMD in Dextrose Injection due to a potential leak that compromises sterility.

    Product
    LMD IN DEXTROSE — LMD IN DEXTROSE (DEXTRAN 40)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0061-2020·2019-10-16

    BD Microtainer Tubes Recalled Due to Damaged Reservoirs

    Becton Dickinson is recalling specific lots of BD Microtainer Tubes with FE Glycolytic Inhibitor because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

    Product
    BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0047-2020·2019-10-16

    Ethicon Recalls STRATAFIX Spiral PDS Plus Violet Sutures

    Ethicon, Inc. is recalling 416 units of STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle sutures because the product does not meet internal strength testing specifications.

    Product
    STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0065-2020·2019-10-16

    Stryker Neurovascular Recalls 8F Balloon Guide Catheters Due to Packaging Error

    Stryker Neurovascular is recalling 190 8F Balloon Guide Catheters because they were incorrectly packaged in 9F Balloon Guide Catheter packaging. The affected lot was distributed only outside the United States.

    Product
    Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0109-2020·2019-10-16

    Roche Tina-quant sTfR Assay Recalled for Rheumatoid Factor Interference

    Roche Diagnostics is recalling Tina-quant Soluble Transferrin Receptor (sTfR) assays due to updated claims regarding rheumatoid factor interference.

    Product
    cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0063-2020·2019-10-16

    Conformis iTotal Hip Replacement Stems Recalled for Packaging Error

    Conformis, Inc. is recalling two iTotal Hip Replacement femoral stems (sizes 13 and 15) because they were packed in each other's packaging.

    Product
    iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0112-2020·2019-10-16

    GE Healthcare Recalls Achilles Bone Sonometers with Incorrect Power Cords

    GE Healthcare is recalling 599 Achilles Insight Bone Sonometers because they were shipped with European power cords that do not meet local safety requirements for protective earth connection.

    Product
    Achilles Insight Bone Sonometer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0052-2020·2019-10-16

    K2M Special Connector Instruments Recalled for Regulatory Filing Deficiencies

    K2M, Inc. is recalling 503 Special Connector Instruments because they were developed without adequate consideration for a new regulatory filing.

    Product
    K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instruments include an additional feature on their shafts that enable surgeon users to combine them with non-K2M navigation systems as part of their stan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0060-2020·2019-10-16

    BD Microtainer PST Tubes Recalled for Damaged Reservoirs

    Becton Dickinson is recalling BD Microtainer PST Tubes with Lithium Heparin because damaged reservoirs may cause insufficient sample volume and erroneous test results.

    Product
    BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0045-2020·2019-10-16

    Helena Laboratories Recalls SPIFE ImmunoFix-6 Kits Due to Missing Control Wells

    Helena Laboratories is recalling 24 SPIFE ImmunoFix-6 kits because the plates lack control wells in the patient 1 area.

    Product
    SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0053-2020·2019-10-16

    Arrow Pediatric Central Venous Catheter Kit Recalled for Labeling Error

    Arrow International Inc. is recalling 3,143 Pediatric Two-Lumen Central Venous Catheterization Kits due to a labeling error on the lidstock.

    Product
    Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0027-2020·2019-10-16

    PopChips Sour Cream & Onion Potato Popped Chips Recalled for Gluten

    Sonora Mills Foods is recalling specific batches of PopChips Sour Cream & Onion Potato Popped Chips because they may contain gluten levels exceeding the firm's specification.

    Product
    Popchips Sour Cream & Onion Potato Popped Chips; 5 oz. bag and 8 oz. bag UPC: 0 82666 50070 4 - 5 oz. 0 82666 77700 7 - 8 oz.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0134-2020·2019-10-16

    Amneal Recalls Benazepril HCl Tablets Due to Foreign Tablet Presence

    Amneal Pharmaceuticals is recalling Benazepril HCl 40 mg tablets because a Promethazine HCl tablet was found in the bottle.

    Product
    BENAZEPRIL HYDROCHLORIDE — BENAZEPRIL HYDROCHLORIDE (BENAZEPRIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0110-2020·2019-10-16

    K2M Recalls Yukon Polyaxial Screws Due to Manufacturing Error

    K2M, Inc. is recalling Yukon Polyaxial Screws because a manufacturing error may prevent them from mating with the screw inserter or set screw as intended.

    Product
    YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm, 4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 26 mm, 4.0 X 28 mm, 4.0 X 30 mm, 5.0 X 22 mm, 5.0 X 28 mm, 5.0 X 30 mm) Cat
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-0048-2020·2019-10-16

    Ethicon Recalls STRATAFIX Spiral Sutures Due to Strength Testing Failures

    Ethicon, Inc. is recalling 852 units of STRATAFIX Spiral PDS Plus Violet 27 sutures because they do not meet internal strength testing specifications.

    Product
    STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0050-2020·2019-10-16

    Baxter Recalls Exactamed Oral Dispensers Due to Mixed Sizes

    Baxter Healthcare is recalling Exactamed 5 mL Oral Dispensers because pharmacy packs may contain 3 mL dispensers, risking inaccurate dosing.

    Product
    EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H93884205, x 1500 - Product Usage: Oral Liquid Dispensers are intended for the accurate dose measurement and clean intermittent adminis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0132-2020·2019-10-16

    DrKids Children's Natural Cough Syrup Recalled for Potential B. cepacia Contamination

    Unipharma, LLC is recalling DrKids Children's Natural Cough Syrup due to a precautionary measure regarding potential contamination with B. cepacia bacteria.

    Product
    DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 UPC 370302489026
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0139-2020·2019-10-16

    Mylan Recalls Rifampin Injection Vials Due to Impurity Concerns

    Mylan Laboratories is recalling 19,165 vials of Rifampin for Injection due to elevated unknown impurities that may reduce product effectiveness.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0113-2020·2019-10-16

    GE Healthcare Recalls Achilles Express Bone Sonometers Due to Power Cord Issue

    GE Healthcare is recalling 241 Achilles Express Bone Sonometers because they were shipped with power cords that do not meet local safety requirements for protective earth connection.

    Product
    Achilles Express Bone Sonometer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0028-2020·2019-10-16

    PopChips Sea Salt & Vinegar Chips Recalled for Gluten Levels

    Sonora Mills Foods is recalling PopChips Sea Salt & Vinegar Potato Popped Chips because some batches may contain gluten levels exceeding the firm's specification.

    Product
    Popchips Sea Salt & Vinegar Potato Popped Chips; 5 oz. bag; 85 g bag - Canada UPC: 0 82666 50050 6 - 5 oz. UPC: 0 82666 71240 4 - 85 g Safeway brand: 5 oz. bag; UPC: 0 21130 29543 2
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0022-2020·2019-10-16

    Abbott Calcilo XD Infant Formula Recalled for Compromised Can Seams

    Abbott Laboratories is recalling 2,922 cans of Calcilo XD infant formula due to off color, odor, and compromised can seams that may allow air entry.

    Product
    Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0023-2020·2019-10-16

    Wismettac Nori Ajitsuke Recalled for Incorrect Seafood Species Labeling

    Wismettac Asian Foods is recalling Nori Ajitsuke because the label incorrectly lists seafood species. The product contains skipjack tuna and krill.

    Product
    Nori Ajitsuke 100P SK 8.81 oz. (250 g) UPC 074410528288 Item #52818
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0046-2020·2019-10-16

    Leica Biosystems Recalls Three Aperio CS2 CE IVD Scanners

    Leica Biosystems is recalling three Aperio CS2 CE IVD scanners due to incorrect sensors that may affect image quality and analysis results.

    Product
    Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0051-2020·2019-10-16

    Repro-Med Systems Recalls Mislabeled Subcutaneous Safety Needle Sets

    Repro-Med Systems is recalling 1,990 pouches of 26-gauge subcutaneous safety needle sets due to mislabeled needle lengths.

    Product
    20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0137-2020·2019-10-16

    Guerbet Recalls Optiray Syringes Due to RFID Formatting Error

    Guerbet LLC is recalling 3,860 Optiray syringes because an RFID formatting error causes the injector to read the product as expired, preventing injection.

    Product
    OPTIRAY — OPTIRAY (IOVERSOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0026-2020·2019-10-16

    PopChips Sea Salt Potato Popped Chips Recalled for Gluten Levels

    Sonora Mills Foods is recalling PopChips Sea Salt Potato Popped Chips because some batches may contain gluten levels exceeding the firm's specification.

    Product
    Popchips Sea Salt Potato Popped Chips; 5 oz. bag, 0.8 oz. bag UPC: 0 82666 50080 3 - 5 oz. ; UPC: 0 82666 71100 1 - 8 oz.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0029-2020·2019-10-16

    PopChips Variety Pack Recalled for Potential Gluten Contamination

    PopChips Variety Pack is being recalled because some batches may contain gluten levels exceeding the firm's specification.

    Product
    Popchips Variety Pack of Sea Salt, BBQ and Sour Cream and Onion Potato Popped Chips; 8 oz. bag UPC: 0 82666 94002 9
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0017-2020·2019-10-16

    Fetting's White Bread Recalled for Potential Foreign Object Contamination

    Fetting's Frozen Foods LLC is recalling specific lots of Fetting's Family Breads White Bread in Minnesota due to the potential presence of a foreign object.

    Product
    Fetting's Family Breads, White Bread, 4-1 lb. loaves. Net Wt. 4 lbs. (1.81 kg) UPC code 75812-79216
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0058-2020·2019-10-16

    BD Microtainer SST- Amber Tubes Recalled for Damaged Reservoirs

    Becton Dickinson is recalling specific lots of BD Microtainer SST- Amber tubes because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

    Product
    BD Microtainer SST- Amber Part/Catalog Number: 365978
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0138-2020·2019-10-16

    Guerbet Recalls Sodium Chloride Syringes Due to RFID Formatting Error

    Guerbet LLC is recalling 3,140 prefilled sodium chloride syringes because an RFID formatting error prevents the Optivantage injector from administering the product.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0131-2020·2019-10-16

    Teva Recalls Matzim LA Tablets Due to GMP Deviation

    Teva Pharmaceuticals USA is recalling 5,849 bottles of Matzim LA (Diltiazem Hydrochloride) 240 mg tablets because the lot was not intended for commercial distribution.

    Product
    MATZIM LA — MATZIM LA (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·19V732000·2019-10-15

    BMW Recalls 2019-2020 330i and Z4 Models for Engine Bearing Defect

    BMW is recalling 2019-2020 330i and 2019 Z4 vehicles because improperly installed counterbalance shaft bearings may loosen, causing severe engine damage and increasing crash risk.

    Product
    BMW — BMW 330I, Z4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V731000·2019-10-15

    GM Recalls 2020 Cadillac CT6 Vehicles for Tire Pressure Sensor Defect

    General Motors is recalling 2020 Cadillac CT6 vehicles with specific dealer-installed wheels because the tire pressure sensors use the wrong frequency, preventing low-pressure warnings.

    Product
    CADILLAC — CADILLAC CT6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V733000·2019-10-15

    Peterbilt 579 Recall for Incorrect Conspicuity Tape Placement

    PACCAR is recalling 2020 Peterbilt 579 sleeper trucks because conspicuity tape may be installed in the wrong location, reducing visibility to other drivers.

    Product
    PETERBILT — PETERBILT 579
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·097-2019·2019-10-14

    Kenosha Beef International Recalls Seasoned Beef Products Due to Metal Contamination

    Kenosha Beef International is recalling seasoned beef products that may contain metal shavings. The recall affects restaurant distribution nationwide.

    Product
    Kenosha Beef International, Ltd. — Kenosha Beef International Recalls Seasoned Beef Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·19V730000·2019-10-14

    E-One Recalls Emergency Vehicles Due to Starter Solenoid Circuit Defect

    E-One is recalling specific emergency vehicles because a missing diode in the starter solenoid circuit can damage the lock-out relay, potentially preventing the vehicle from starting.

    Product
    E-ONE — E-ONE TYPHOON, QUEST II, CYCLONE II, CHSH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V728000·2019-10-11

    Arcimoto Recalls 2019 FUV Motorcycles Due to Tie Rod Separation Risk

    Arcimoto is recalling 2019 FUV motorcycles because insufficient thread engagement in the tie rods could cause separation, leading to loss of steering and increased crash risk.

    Product
    ARCIMOTO — ARCIMOTO FUV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19E069000·2019-10-11

    ASA Electronics Recalls Relay Modules for Voyager Rear Camera Displays

    ASA Electronics is recalling specific relay/capacitor modules used in Voyager rear camera displays. The modules may fail, causing loss of power to the display and increasing crash risk.

    Product
    BACK OVER PREVENTION: SENSING SYSTEM: CAMERA recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V727000·2019-10-11

    Forest River Recalls 2020 Shasta Trailers Due to Axle Hanger Defect

    Forest River is recalling 2020 Shasta Oasis SST30QB and SST31OK trailers because an incorrect axle hanger length may cause the axle to contact the chassis, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER SHASTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·096-2019·2019-10-11

    YOUBITE Recalls Pork and Turkey Sausage Due to Undeclared Casings

    YOUBITE, LLC is recalling approximately 7,197 pounds of pork and turkey sausage products because they contain natural sheep or pork casings not declared on the label.

    Product
    The Sausage LLC — YOUBITE, LLC Recalls Pork Sausage and Turkey Sausage Products due to Mislabeling
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V722000·2019-10-10

    Western Star 4900 and 5700 Recall for Door Hinge Adhesive Failure

    Daimler Trucks North America is recalling 2017-2020 Western Star 4900 and 5700 trucks because the adhesive bond on side doors may fail, allowing doors to separate from the vehicle.

    Product
    WESTERN STAR — WESTERN STAR 4900, 5700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E068000·2019-10-10

    Dorman Recalls Accelerator Pedal Assemblies for Acura and Honda Vehicles

    Dorman is recalling specific accelerator pedal assemblies for Acura and Honda vehicles because the rotating portion may bind, increasing crash risk.

    Product
    ACURA — ACURA, HONDA MDX, ACCORD, RIDGELINE, CR-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·20009·2019-10-10

    Carrier Recalls Ductless Heat Pumps Due to Fire Hazard

    Carrier is recalling specific ductless heat pumps because a fan motor failure can cause overheating and fire. No injuries have been reported.

    Product
    Carrier- and Bryant-branded 1.5-ton multi-zone, 4-ton multi zone and 4-ton single-zone ductless heat pumps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V718000·2019-10-10

    2020 Thomas Built Buses Minotour Recall for Seatbelt Warning Light Defect

    Daimler Trucks North America is recalling 2020 Thomas Built Buses Minotour school buses because the seatbelt-unfastened warning light may not illuminate for five seconds after ignition.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2564-2019·2019-10-09

    Medtronic Recalls SHERPA NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 538 units of SHERPA NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2646-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 492 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MB1, .070", REF SA6MB1. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·F-0019-2020·2019-10-09

    SE Grocers Bakery Variety Pack Cookies Recalled for Undeclared Peanut

    Southeastern Grocers is recalling 18-count Variety Pack Cookies made in-store because peanut butter cookies were included without declaring peanuts on the label.

    Product
    SE Grocers **BAKERY** 18 CT Variety Pack Cookies
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Devices)·Z-2660-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 409 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F 3DRIGHT, .070", REF SA63DRIGHT. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2618-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 15,603 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070", REF SA6JR40. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2682-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 62 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MP2, .070", REF SA6MP2. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2601-2019·2019-10-09

    Medtronic Recalls 10 Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 10 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, PK1, 47CM, 070", REF SA6PK1W. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2722-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 9 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F FR3.5, .070", REF SA6FR35. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2600-2019·2019-10-09

    Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling 4 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO SH, 100CM, 070", REF SA6NOTOSH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2736-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 52 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JCL4.0, .070", REF SA6JCL40. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2596-2019·2019-10-09

    Medtronic Recalls Six Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, MB1, 90CM, 070", REF SA6MB1D. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2686-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 51 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5 SH, .070", REF SA6JL45SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2650-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 305 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB, .070", REF SA6LCB. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2751-2019·2019-10-09

    Medtronic Recalls SHERPA NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 3 units of SHERPA NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2626-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 614 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5 SH, .070", REF SA6EBU35SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2676-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 57 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.5 SH, .070", REF SA6MAC35SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2725-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 16 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 SH, .070", REF SA6MAC30SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2589-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 22 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 110CM, 070", REF SA6JL40A. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2691-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 23 units of Sherpa NX Active Guiding Catheters because of a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5, .070", REF SA6CHAMP15. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2696-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 37 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JL6.0 SH, .070", REF SA6JL60SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2638-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 364 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0 SH, .070", REF SA6AL10SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2587-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 27 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, JCR4.0, 100CM, 070", REF SA6JCR40. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2565-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling 12 units of the SHERPA NX Active Guiding Catheter due to a potential for extensive loss of primary segment material, which exposes underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2717-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 40 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.5 SH, .070", REF SA6AL15SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2727-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 9 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F RELAXED MOD HSII, .070", REF SA6RMHSII. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2709-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 8 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.5 SH, .070", REF SA6SAL15SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2630-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 90 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5, .070", REF SA6JR45. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2627-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 167 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, .070", REF SA6ERADL. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2594-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 39 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 55CM, 070", REF SA6JR40K. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2715-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 57 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0, .070", REF SA6JR60. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2670-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 615 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070", REF SA6JR405. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2603-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 55 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5 SH, 100CM, 070", REF SA6RBU35SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2729-2019·2019-10-09

    Medtronic Sherpa NX Active Guiding Catheter Recalled for Material Loss

    Medtronic Vascular is recalling 3 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0 SH, .070", REF SA6MAC40SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0061-2020·2019-10-09

    KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling Hydroxocobalamin 10 mL vials because the company cannot ensure the product is sterile. The recall covers 1,528 units distributed nationwide.

    Product
    Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678336
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0085-2020·2019-10-09

    KRS Global Biotechnology Recalls Phenylephrine and Lidocaine Ophthalmic Injection

    KRS Global Biotechnology is recalling 3,150 vials of Phenylephrine HCl and Lidocaine Ophthalmic Injection due to a lack of assurance of sterility.

    Product
    PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL fill in a 5 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678170
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0047-2020·2019-10-09

    KRS Global Biotechnology Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling ephedrine sulfate syringes nationwide because the company cannot guarantee the product is sterile.

    Product
    ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678374
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2690-2019·2019-10-09

    SHERPA NX Active Guiding Catheter recall due to exposed stainless-steel braid wires

    A recall of Medtronic Vascular SHERPA NX active guiding catheters was issued because some units may expose underlying stainless-steel braid wires, posing a potential safety risk.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.5, .070", REF SA6SL45. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0090-2020·2019-10-09

    KRS Global Biotechnology Recalls Polidocanol Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 317 vials of Polidocanol 5% for IV use nationwide due to a lack of assurance of sterility.

    Product
    Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677749
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0116-2020·2019-10-09

    KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns

    KRS Global Biotechnology is recalling 242 droptainers of a sterile ophthalmic solution because the company cannot guarantee the product's sterility.

    Product
    Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer,Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, F
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0080-2020·2019-10-09

    KRS Global Biotechnology Recalls Repinephrine IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 528 bags of Repinephrine in 0.9% Sodium Chloride due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487, NDC 3321678032
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0118-2020·2019-10-09

    KRS Global Biotechnology Recalls Isoproterenol HCL IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling Isoproterenol HCL IV bags because the company cannot ensure the product is sterile.

    Product
    Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains Sulfites, For Slow IV use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677610
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2703-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 12 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SAR1.0, .070", REF SA6SAR10. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0041-2020·2019-10-09

    KRS Global Biotechnology Recalls Ascorbic Acid Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 602 vials of Ascorbic Acid (Tapioca Source) 25 g/50 mL due to a lack of assurance of sterility.

    Product
    Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains Sulfites, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675033
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2563-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 658 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070", REF SA6RDND1K. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0036-2020·2019-10-09

    Quality Electrodynamics Recalls MRI Knee Coils Due to Ferrous Material Risk

    Quality Electrodynamics LLC is recalling 36 Siemens MRI knee coils because unintended ferrous material may be present in the pushbutton assembly.

    Product
    TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0016-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-MB12/HB12 Injection Due to Sterility Concerns

    Colonia Care Pharmacy is recalling six syringes of C-MB12/HB12 5MG/5MG/ML Injection Solution because the product's sterility cannot be guaranteed. The affected lot was distributed via patient-specific prescriptions in New Jersey.

    Product
    C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state

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