The Recall Desk

Archive

May 2020 recalls

456 recalls were announced in May 2020.

What the numbers show

Critical
3
Severe
95
High
244
Moderate
97
Low
17

Of the 456 recalls this month scored against our rubric, 1% are Critical, 21% are Severe.

101–200 of 456

  • ModerateFDA (Devices)·Z-2096-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recall Due to Packaging Defect

    Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may fall off its post in the inner packaging, resulting in coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2089-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right, Sterile, Catalog # 504-02-58D-R, UDI (01)07613327012446(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2093-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled for Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shells because the device may detach from its post within the inner packaging, resulting in loose components and coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Drugs)·D-1282-2020·2020-05-27

    West-Ward Recalls Ethacrynic Acid Tablets for Impurity Failures

    West-Ward Columbus Inc is recalling Ethacrynic Acid Tablets USP, 25 mg, because the product failed impurity and degradation specifications.

    Product
    Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2064-2020·2020-05-27

    Philips HeartStart MRx Processor Board Replacement Kits Recalled for Damaged Bags

    Philips is recalling HeartStart MRx Processor Board PCA Replacement Kits because damaged ESD bags were used for storing components.

    Product
    HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified medical personnel trained in the operation of the device and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0956-2020·2020-05-27

    Frito-Lay Recalls Ruffles Onion Dip Jars Due to Mold Contamination Risk

    Frito-Lay is recalling Ruffles Onion flavoured dip jars in the US and Canada due to potential mold contamination.

    Product
    Ruffles Onion flavoured dip 425 g (15 oz). UPC 6041007298 packaged in clear glass jars
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2067-2020·2020-05-27

    DFINE Vertebral Hydraulic Assemblies Recalled for Incorrect Expiration Dates

    Merit Medical Systems is recalling 228 DFINE Vertebral Hydraulic Assemblies because the labels display a five-year expiration date instead of the correct two-year shelf life.

    Product
    DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1271-2020·2020-05-27

    Mylan Recalls Aloprim Injection Vials Due to Discoloration

    Mylan Institutional LLC is recalling 3,010 vials of Aloprim (allopurinol sodium) for Injection due to out-of-specification appearance and color results.

    Product
    ALOPRIM — ALOPRIM (ALLOPURINOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0957-2020·2020-05-27

    Frito-Lay Recalls Ruffles Ranch Dip Jars Due to Potential Mold Contamination

    Frito-Lay is recalling Ruffles Ranch flavoured dip in 425 g glass jars sold in the US and Canada due to potential mold contamination.

    Product
    Ruffles Ranch flavoured dip 425 g (15 oz). UPC 6041007299 packaged in clear glass jars
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2068-2020·2020-05-27

    Merit Medical Recalls DFINE Vertebral Assemblies Due to Incorrect Expiration Dates

    Merit Medical Systems is recalling 63 DFINE Vertebral Assemblies because the labels display a five-year expiration date instead of the correct two-year shelf life.

    Product
    DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fract
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2098-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post in the inner packaging, resulting in loose coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile, Catalog # 504-02-68F-L, UDI (01)07613327012521(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2099-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shell devices because they may fall off their post in packaging, resulting in loose devices with coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile, Catalog # 504-02-68F-R, UDI (01)07613327012514(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2092-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shell devices because they may fall off their posts within the inner packaging, resulting in loose devices and coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile, Catalog # 504-02-62E-L, UDI (01)07613327012453(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2091-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recall Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2078-2020·2020-05-27

    Becton Dickinson Recalls Bard MyPICC Kits Due to Gown Issue

    Becton Dickinson is recalling Bard MyPICC Kits because the included surgical gowns were subject to a supplier recall.

    Product
    BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2094-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateCPSC·20127·2020-05-27

    Primark Recalls Kitten Heel Court Shoes Due to Chromium Levels

    Primark is recalling Wide Fit Kitten Heel Court Pumps because the leather insoles contain elevated levels of Chromium VI, posing a risk of skin irritation.

    Product
    Wide Fit Kitten Heel Court Pumps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2041-2020·2020-05-27

    ImmersiveView software version 2.1 recalled for internal repetitive glitch

    Immersivetouch Inc is recalling two units of ImmersiveView software version 2.1 due to an observed internal repetitive software glitch.

    Product
    ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-1272-2020·2020-05-27

    InvaGen Recalls Gabapentin Tablets Due to Impurity Test Failure

    InvaGen Pharmaceuticals is recalling 2,202 bottles of Gabapentin 600 mg tablets because they failed an impurity test during stability testing.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2038-2020·2020-05-27

    Pega Medical Recalls SLIM System Handle Due to Lot Number Mismatch

    Pega Medical Inc. is recalling three units of the SLIM System handle because the lot number on the instrument does not match the packaging label.

    Product
    Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V301000·2020-05-26

    Altec Recalls Aerial Devices With Incorrect Tow Hitch Load Ratings

    Altec is recalling 2014-2020 Aerial Devices with Class 3 towing hitches that may have incorrect load ratings or damage from overloading, increasing crash risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V302000·2020-05-26

    2020-2021 Keystone Cougar travel trailer cooktop fire hazard

    Keystone is recalling 2020-2021 Cougar travel trailers because the cooktop may not be properly sealed from the furnace, causing burner flames to invert and increasing fire risk. Dealers will inspect and seal it free of charge.

    Product
    KEYSTONE — KEYSTONE COUGAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V300000·2020-05-23

    AEV TraumaHawk Ambulances Recalled for Rear Brake Line Wear Risk

    Halcore Group is recalling 2019-2020 AEV TraumaHawk ambulances because rear brake lines may wear from contact with suspension parts, risking brake loss.

    Product
    AEV — AEV TRAUMAHAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·007-2020-EXP ·2020-05-22

    Conagra Recalls Frozen Chicken and Turkey Bowls Due to Rock Contamination

    Conagra Brands is recalling approximately 276,872 pounds of frozen Healthy Choice Power Bowls because they may contain small rocks. No illnesses have been reported.

    Product
    Conagra Brands (Conagra Foods Packaged Foods, LLC) — Conagra Brands, Inc. Recalls Frozen Not-Ready-To-Eat Chicken and Turkey Bowl Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·20V297000·2020-05-22

    2020-2021 Forest River Surveyor Travel Trailers Safety Chain Recall

    Forest River is recalling 2020-2021 Surveyor travel trailers because the safety chains are insufficient for the trailer's weight rating and may break if the trailer becomes unhitched, risking complete detachment.

    Product
    FOREST RIVER — FOREST RIVER SURVEYOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V299000·2020-05-22

    Triple E Recalls 2020 Unity Travel Trailers Due to Latch Defect

    Triple E is recalling 2020 Unity travel trailers because a latch may lock, blocking access to the propane shutoff valve and increasing fire risk.

    Product
    TRIPLE E — TRIPLE E UNITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V298000·2020-05-22

    Mercedes-Benz Recalls 2012 C-Class Vehicles for Incorrect Air Bag Replacement

    Mercedes-Benz is recalling 2012 C-Class vehicles where an incorrect front passenger air bag may have been installed during a prior recall, potentially reducing crash protection.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG C63, C250, C300, C350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V294000·2020-05-21

    Dennis Eagle Elite Garbage Trucks Recalled for Braking System Defect

    Dennis Eagle is recalling 2017-2018 Elite garbage trucks because the anti-lock braking system may activate on the wrong side, increasing stopping distance.

    Product
    DENNIS EAGLE — DENNIS EAGLE ELITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20747·2020-05-21

    Herman Miller and Design Within Reach Recall Dressers and Cabinets for Tip-Over Hazards

    Herman Miller and Design Within Reach are recalling Nelson and Lauki dressers and cabinets because they can tip over and entrap children. Consumers should stop using unanchored units and contact the company for a refund.

    Product
    Nelson and Lauki Dressers and Cabinets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V295000·2020-05-21

    2021 Chevrolet Trailblazer lacks tire size and pressure label information

    General Motors is recalling certain 2021 Chevrolet Trailblazer vehicles with optional sport terrain tires because their certification labels do not show tire size and cold tire pressure information required by federal safety standards.

    Product
    CHEVROLET — CHEVROLET TRAILBLAZER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20746·2020-05-21

    Viva Doria Recalls Wintergreen Essential Oil Due to Packaging Defect

    Viva Doria is recalling Wintergreen Essential Oil because the packaging is not child-resistant, posing a risk of poisoning if swallowed by young children.

    Product
    Viva Doria Wintergreen Essential Oil
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V291000·2020-05-20

    Horton Emergency Vehicles Recalled for Rear Brake Line Wear Risk

    Halcore is recalling 2018-2020 Horton ambulances because a rear brake line may wear from contact with suspension parts, risking brake loss.

    Product
    HORTON — HORTON TYPE III, TYPE I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1957-2020·2020-05-20

    Siemens Cios Alpha Mobile X-Ray System Recalled for Electrical Shock Risk

    Siemens is recalling four Cios Alpha mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage.

    Product
    Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1991-2020·2020-05-20

    FDA Recalls Dover Foley Catheters Due to Temperature Sensor Inaccuracy

    The FDA is recalling specific lots of Dover Foley catheters because their temperature sensors may not measure accurately. This could lead to incorrect patient diagnoses.

    Product
    Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code P4P16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1944-2020·2020-05-20

    Beckman Coulter iChem VELOCITY Urine Chemistry System Recalled for Fire Risk

    Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Systems due to a defect in the SATA power adapter cable that poses a risk of electrical short, smoke, or flames.

    Product
    iChem¿VELOCITY Urine Chemistry System-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1960-2020·2020-05-20

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Arm Faults

    Intuitive Surgical is recalling 74 da Vinci Xi Surgical Systems because a manufacturing variation can cause arm faults and loss of functionality during surgery.

    Product
    da Vinci Xi Surgical System
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1933-2020·2020-05-20

    Philips Zenition 70 Trolley Cable Recall for Electrical Contact Failure

    Philips is recalling 25 Zenition 70 systems because strain relief loss on the trolley cable can break electrical contacts, exposing live parts.

    Product
    Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1945-2020·2020-05-20

    Beckman Coulter iQ200 Urine Analyzer Recalled for Electrical Short Risk

    Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers due to a defect in the SATA power adapter cable that poses a risk of electrical short, charring, smoke, or flames.

    Product
    iQ200 Series Urine Microscopy Analyzer- All part numbers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1932-2020·2020-05-20

    Philips Zenition 50 Medical Device Recalled for Electrical Contact Failure

    Philips is recalling 25 Zenition 50 devices because strain relief loss can cause electrical contacts to break, potentially exposing live parts or losing the video signal.

    Product
    Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V284000·2020-05-20

    REV Recalls 2018-2020 Type 1 Ambulances for Rear Brake Line Wear

    REV is recalling 2018-2020 Type 1 ambulances because a rear brake line may wear, causing brake failure and increasing crash risk.

    Product
    FRONTLINE — FRONTLINE, ROAD RESCUE, WHEELED COACH TYPE I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0945-2020·2020-05-20

    Whole Foods Market Queso Sauce Recalled for Undeclared Cashews

    Whole Foods Market is recalling Queso Sauce sold in Arizona due to a potential undeclared cashew allergen.

    Product
    Whole Foods Market Queso Sauce PLU code printed on the product scale labels beginning with 74135 sold in clear plastic deli-style containers of various weights.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1269-2020·2020-05-20

    MasterPharm Recalls Finasteride Plus Capsules Due to Minoxidil Contamination

    MasterPharm LLC is recalling Finasteride Plus 1.25 mg capsules because they were found to contain minoxidil. The recall covers 7,260 capsules distributed nationwide.

    Product
    Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Compounded Product Not for Resale, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V283000·2020-05-20

    BMW and MINI Recall Vehicles Due to Rollover Sensor Defect

    BMW is recalling certain 2020-2021 vehicles because a rollover sensor defect may prevent air bags and seat belt pretensioners from deploying in a crash.

    Product
    MINI — MINI, BMW COOPER S CLUBMAN, X1, X2, COOPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V293000·2020-05-20

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

    Vac-Tron is recalling 2016-2020 vacuum excavator trailers because the rear extends too far, failing federal safety standards and increasing crash risks.

    Product
    VAC-TRON — VAC-TRON CS 1270 GT, CS 870 GT, CS 873 GT, CV 1273 GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V286000·2020-05-20

    Toyota Recalls 2019-2020 RAV4 Models for Front Suspension Arm Cracks

    Toyota is recalling 2019-2020 RAV4 and RAV4 Hybrid vehicles because front lower suspension arms may crack and separate, risking loss of vehicle control.

    Product
    TOYOTA — TOYOTA RAV4, RAV4 HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V289000·2020-05-20

    Vac-Tron Recalls 2016-2020 Vacuum Excavator Trailers for Lighting Defects

    Vac-Tron is recalling 2016-2020 vacuum excavator trailers because improper lighting and missing reflectors may reduce visibility, increasing crash risk.

    Product
    VAC-TRON — VAC-TRON CS 1270 GT, CS 573 GT, CS 1270 SGT, CS 500 DT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2020·2020-05-20

    Cardiac Assist Recalls 15 TandemHeart Pumps Due to Assembly Error

    Cardiac Assist, Inc. is recalling 15 TandemHeart pump kits due to an assembly error that may prevent the device from priming.

    Product
    TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1973-2020·2020-05-20

    Access Scientific Recalls BD PosiFlush Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 6,254 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80701/10859821006213 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contras
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2020·2020-05-20

    BD Alaris PCEA Administration Set Recalled for Potential Leaking

    BD is recalling Alaris PCEA Administration Sets because they may leak at the luer connection, potentially causing inadequate pain control.

    Product
    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1988-2020·2020-05-20

    Dover Silicone Foley Catheter Recalled for Temperature Sensor Inaccuracy

    Covidien is recalling Dover 100% Silicone Foley trays because the temperature sensors failed to meet calibration standards, potentially leading to incorrect patient diagnoses.

    Product
    Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P14TSD - Product Usage: for Drainage of the Ur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1934-2020·2020-05-20

    CuattroDR System Software Recalled for Potential Image Misattribution

    Cuattro LLC is recalling CuattroDR System Software because images from previous patient studies may appear in later studies, potentially leading to misdiagnosis.

    Product
    CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1984-2020·2020-05-20

    Dover Silicone Foley Catheter Recalled for Temperature Sensor Inaccuracy

    FDA recalls 468 Dover Foley catheters with temperature sensors that failed accuracy tests. Incorrect readings could lead to misdiagnosis.

    Product
    Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1963-2020·2020-05-20

    DeRoyal Sterile Custom Kits Recalled Due to Packaging Holes

    DeRoyal Industries is recalling sterile custom kits packaged with BD PosiFlush syringes because holes in the packaging may compromise sterility.

    Product
    DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack Pgybk, 89-6209.03 b. H* Vein Pack, 89-6209.04 c. PICC Line Tray Pgybk, 89-6150.12 d. Umbilical Arterial Cath, 89-9370.01 e. P
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1929-2020·2020-05-20

    Encore Medical Recalls EMPOWR Acetabular Impactor Balls Due to Fracturing

    Encore Medical is recalling 86 units of EMPOWR Acetabular Impactor Balls because they may fracture during use, potentially leaving debris in the joint space.

    Product
    EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to noninflammat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2003-2020·2020-05-20

    Inpeco FlexLab Interface Module Recalled for Sample Cross-Contamination Risk

    Inpeco S.A. is recalling 82 FlexLab Interface Modules because a timeout error could cause sample cross-contamination.

    Product
    Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1982-2020·2020-05-20

    Access Scientific Recalls BD PosiFlush Saline Flush Syringes Due to Packaging Defects

    Access Scientific LLC is recalling 50 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit. REF/UDI / 94115/10859821006251 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·20125·2020-05-20

    Bunz Kidz Children's Sleepwear Sets Recalled for Burn Hazard

    Stargate Apparel is recalling Bunz Kidz children's sleepwear sets because they fail to meet federal flammability standards, posing a risk of burn injuries.

    Product
    Bunz Kidz Children's Sleepwear Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1980-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 4,187 saline flush syringes used in vascular kits because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit. REF/UDI / 94123/10859821006473 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast med
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V285000·2020-05-20

    Navistar Recalls 2019-2020 International CV Vehicles Due to ABS Software Error

    Navistar is recalling 2019-2020 International CV vehicles because a software error may prevent the ABS warning light from illuminating, potentially leaving drivers unaware of system failures.

    Product
    INTERNATIONAL — INTERNATIONAL CV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2004-2020·2020-05-20

    Inpeco Abbott Accelerator a3600 Interface Module Recalled for Cross-Contamination Risk

    Inpeco S.A. is recalling 273 Abbott Accelerator a3600 Interface Modules because a timeout error could cause sample cross-contamination.

    Product
    Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1994-2020·2020-05-20

    Recall of Dover Foley Catheters Due to Temperature Sensor Inaccuracy

    FDA is recalling specific Dover Foley catheters because their temperature sensors failed to meet calibration standards, potentially leading to incorrect patient diagnoses.

    Product
    Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P18XTSD - Product Usage:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1979-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 570 units of BD PosiFlush SF Saline Flush Syringes used in POWERWAND XL catheters because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1956-2020·2020-05-20

    Merit Medical Recalls Custom Sheath Introducer Kits Due to Labeling Error

    Merit Medical Systems is recalling 15 Custom Sheath Introducer Kits because they were incorrectly labeled and contained the wrong sheath assembly.

    Product
    Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1955-2020·2020-05-20

    Cardiac Assist Recalls 13 TandemLife Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling 13 TandemLife Kits because an assembly error may prevent the pump from priming. The kits provide temporary circulatory support.

    Product
    TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1992-2020·2020-05-20

    FDA Recalls Dover Foley Catheters Due to Temperature Sensor Failures

    FDA is recalling Dover Foley catheters because their temperature sensors failed to meet calibration standards, which could lead to incorrect patient diagnoses.

    Product
    Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P16XTSD - Product Usage:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1936-2020·2020-05-20

    Argon Medical Devices Recalls Arterial Line Kits Due to Needle Defect

    Argon Medical Devices is recalling 150 Arterial Line Kits because they contain a thicker suture and curved needle that may increase the risk of needle sticks.

    Product
    Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required. Case Label:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1987-2020·2020-05-20

    Dover Foley Catheter Recalled for Temperature Sensor Calibration Failures

    Covidien is recalling Dover Foley catheters with temperature sensors that failed to meet calibration tolerances, posing a risk of incorrect diagnosis.

    Product
    Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2020·2020-05-20

    Magstim Recalls Rapid2 Stim Interconnecting Cables Due to Potential Failure

    The Magstim Company Limited is recalling 71 Rapid2 PSU Stim Interconnecting Cables because the high-voltage cable may fail. The recall covers units distributed worldwide.

    Product
    Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1976-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Defects

    Access Scientific LLC is recalling 1,864 units of BD PosiFlush SF Saline Flush Syringes used in POWERWAND XL kits because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit. REF/UDI / 94106/10859821006176 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1935-2020·2020-05-20

    Stryker Power-PRO TL Ambulance Cots Recalled for Crash Test Non-Compliance

    Stryker is recalling 34 Power-PRO TL ambulance cots in the UK because they may not meet the crash test standard BS EN 1789.

    Product
    Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0946-2020·2020-05-20

    Essential Baking Company Recalls Organic Sliced Columbia Bread for Undeclared Egg

    The Essential Baking Company is recalling 84 loaves of Organic Sliced Columbia bread in Washington due to undeclared egg.

    Product
    The product is twisted bread and packaged in a flexible plastic bag with a yellow Kwik-Lok seal. The label is read in parts: "***ORGANIC SLICED COLUMBIA*** Net Weight 32 ounces *** The ESSENTIAL BAKING Company***INGREDIENTS: Organic Unbleached Wheat Flour, Water, Organic Who
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1953-2020·2020-05-20

    Cardiac Assist Recalls Six TandemHeart Pump Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling six TandemHeart pump kits because an assembly error may prevent the device from priming.

    Product
    TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1968-2020·2020-05-20

    BD Alaris PCEA Administration Set Recalled for Potential Leakage

    BD Switzerland is recalling 110,350 units of Alaris PCEA Administration Sets due to a potential leak at the luer connection that may cause inadequate pain control.

    Product
    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 7,395 saline flush syringes used in POWERWAND kits because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/10859821006169 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast med
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1938-2020·2020-05-20

    Argon Medical Devices Recalls PAC Tray Catheter Introducer Kits

    Argon Medical Devices is recalling 80 PAC Tray/5 Catheter Introducer Trays due to incorrect needle and suture components that may increase the risk of needle sticks.

    Product
    PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. Curved tip Introducer allows for c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1952-2020·2020-05-20

    Cardiac Assist Recalls TandemHeart ProtekDuo Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling 46 TandemHeart ProtekDuo Kits due to an assembly error that may cause failure to prime.

    Product
    TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1983-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 110 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1972-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Defects

    Access Scientific LLC is recalling 2,697 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 00859821006674 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast med
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1959-2020·2020-05-20

    Siemens Cios Spin Mobile X-Ray System Recalled for Electrical Shock Risk

    Siemens is recalling 46 Cios Spin mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage.

    Product
    Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1940-2020·2020-05-20

    Cook Inc. Recalls Formula 418 Renal Balloon-Expandable Stents

    Cook Inc. is recalling 10 Formula 418 Renal Balloon-Expandable Stents because the stent may dislodge from the delivery system before deployment.

    Product
    Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system. Th
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1947-2020·2020-05-20

    Sunrise Medical Recalls Quickie and Zippie Powered Wheelchairs Due to Controller Error

    Sunrise Medical is recalling specific Quickie and Zippie powered wheelchairs because a controller programming error allows users to set motor parameters beyond safe limits.

    Product
    Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966).
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1967-2020·2020-05-20

    BD Alaris PCEA Administration Set Recalled for Potential Leaking

    BD is recalling 110,350 Alaris PCEA Administration Sets because they may leak at the luer connection, potentially causing inadequate pain control.

    Product
    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1954-2020·2020-05-20

    Cardiac Assist Recalls TandemLung Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling two TandemLung Kit units because an assembly error may prevent the pump from priming.

    Product
    TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2020·2020-05-20

    Magstim Horizon PSU Stim Interconnecting Cable Recalled for Potential Failure

    The Magstim Company Limited is recalling 71 Horizon PSU Stim Interconnecting Cables because the high-voltage cable may fail. The device is used for treating Major Depressive Disorder.

    Product
    Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V288000·2020-05-20

    Vac-Tron Vacuum Excavator Trailers Recalled for Lighting and Reflectivity Defects

    Vac-Tron is recalling 2016-2020 vacuum excavator trailers because improper lamp positioning and missing reflectors may reduce visibility and increase crash risk.

    Product
    VAC-TRON — VAC-TRON LP MINI 373 GT, LP MINI 373 DT, CS 870 GT, CS 873 GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V290000·2020-05-20

    Vac-Tron Vacuum Excavator Trailers Recalled for Lighting Defects

    Vac-Tron is recalling 2016-2020 vacuum excavator trailers because front clearance lamps may be positioned improperly and reflectors may be missing, increasing crash risk.

    Product
    VAC-TRON — VAC-TRON LP 1273 XDT, CS 1270 GT, CS 1273 GT, CS 870 GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1990-2020·2020-05-20

    Dover Silicone Foley Catheter Recalled for Temperature Sensor Inaccuracy

    FDA is recalling Dover silicone Foley catheters because temperature sensors failed to meet calibration standards, risking incorrect patient diagnoses.

    Product
    Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P16TSD - Product Usage: for Drainage of the U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1977-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 2,055 saline flush syringes because holes in the packaging compromised their sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier Kit. REF/UDI / 94107/10859821006206 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1958-2020·2020-05-20

    Siemens Cios Alpha Mobile X-Ray System Recalled for Electrical Shock Risk

    Siemens is recalling 16 Cios Alpha mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage and shock.

    Product
    Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0939-2020·2020-05-20

    Joseph's Gluten Free Original Wrap Recalled for Containing Gluten

    Middle East Bakery is recalling Joseph's Gluten Free Original Wraps because the product contains gluten, posing a risk to consumers with celiac disease or gluten sensitivity.

    Product
    Joseph's Gluten Free Original Wrap, 4 wraps, Net. Wt. 5.6 oz., UPC Code: 074117-003612
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-1986-2020·2020-05-20

    Dover Silicone Foley Catheters Recalled for Temperature Measurement Failures

    FDA is recalling Dover 100% Silicone Foley Catheters because they failed to meet temperature sensing tolerances, potentially leading to incorrect diagnoses.

    Product
    Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1985-2020·2020-05-20

    Dover Foley Catheters Recalled for Temperature Sensor Inaccuracy

    FDA is recalling 480 Dover Foley catheters with temperature sensors that failed to meet accuracy standards, posing a risk of incorrect patient diagnosis.

    Product
    Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2007-2020·2020-05-20

    Edwards Lifesciences Recalls Sterile Oxymetry Oligon Catheter Kits

    Edwards Lifesciences is recalling 597 sterile catheter kits because their packaging was compromised, potentially affecting sterility.

    Product
    Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1981-2020·2020-05-20

    Access Scientific Recalls Pediatric Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 120 units of BD PosiFlush SF Saline Flush Syringes used in pediatric kits because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit. REF/UDI / 94124/10859821006480 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast
    Category
    Medical Device
    Distribution
    Distributed nationwide

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