The Recall Desk

Manufacturer

Angiodynamics Inc. (Navilyst Medical Inc.)

78 recalls in our database name Angiodynamics Inc. (Navilyst Medical Inc.) as the manufacturing or recalling firm.

What the numbers show

Total
78
Critical
0
Severe
27
Most recent
2021-10-06

Of the 78 recalls from Angiodynamics Inc. (Navilyst Medical Inc.) we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 27 (35%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 78

  • HighFDA (Devices)·Z-2199-2018·2018-06-20

    Angiodynamics Recalls BioFlo Midline Kits Due to Bacterial Endotoxins

    Angiodynamics Inc. is recalling 23 boxes of BioFlo Midline kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2191-2018·2018-06-20

    Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk

    Angiodynamics Inc. is recalling 20 boxes of Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2206-2018·2018-06-20

    Angiodynamics Recalls TANDEM 5F DL BIOFLO PASV Kits Due to Endotoxins

    Angiodynamics Inc. is recalling TANDEM 5F DL BIOFLO PASV kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2215-2018·2018-06-20

    Angiodynamics Recalls RS TANDEM 5F DL BIOFLO PASV Catheters

    Angiodynamics Inc. is recalling 20 boxes of RS TANDEM 5F DL BIOFLO PASV catheters because a component may contain unsafe levels of bacterial endotoxins.

    Product
    RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-1390-2018·2018-04-25

    NAMIC Fluid Management Convenience Kits Recalled for Assembly Defect

    Angiodynamics Inc. is recalling 38 NAMIC Fluid Management Convenience Kits because the Fluid Delivery Set was not assembled to specification, preventing device use.

    Product
    Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0242-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the included introducer sheaths have handles that may detach during use.

    Product
    XCELA PASV 5F DL 55CM MST-70 KIT PG, UPN H965457320, Catalog No. 45-732 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intrav
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0244-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheaths have handles that may detach during use.

    Product
    Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, UPN H965458180, Catalog No. 45-818 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0252-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment Risk

    Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the included introducer sheath handles may detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0241-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included Greatbatch introducer sheaths have handles that may detach during use.

    Product
    XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260, Catalog No. 25-126 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0245-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheaths may have handles that detach during use.

    Product
    Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-833 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Sheath Defect

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheath handles may detach during use.

    Product
    XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intrav
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0246-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment Risk

    Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the included introducer sheaths may have handles that detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0250-2018·2017-12-20

    Navilyst Medical Recalls PICC Kits Due to Potential Handle Detachment

    Navilyst Medical is recalling specific PICC kits because the included introducer sheath handles may detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0247-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheath handles may detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0240-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheath handles may detach during use.

    Product
    Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0249-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the introducer handles may detach from the sheath during use.

    Product
    Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog No. 45-889 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0251-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the introducer sheath handles may detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0248-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the included introducer sheaths may have handles that detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830, Catalog No. 45-883 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1853-2017·2017-04-26

    NAMIC Fluid Delivery Set Recalled for Potential Non-Sterility

    Angiodynamics Inc. is recalling NAMIC Fluid Delivery Sets because they may not be sterile due to packaging errors.

    Product
    NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1137-2017·2017-02-15

    AngioDynamics Recalls Celerity ECG Cable Accessory Packs Due to Soldering Defect

    AngioDynamics is recalling Celerity ECG Cable Accessory Packs because the ECG clip cable may not be soldered correctly, potentially preventing the device from conducting ECG signals.

    Product
    Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls Technical Park, Glens Falls, NY 12801; and (b) medCOMP UPN/
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0709-2017·2016-12-14

    BioFlo PICC Nursing Kits Recalled for Incorrect Glove Expiration Dates

    Navilyst is recalling BioFlo PICC Maximal Barrier Nursing Kits because the included sterile gloves have incorrect expiration dates.

    Product
    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H965750241/Catalog No: 5020644, 5) UPN # H965750325/Catalog No: 5026458, 6) UPN #
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0715-2017·2016-12-14

    Angiodynamics Recalls PICC Catheters Due to Stylet Diameter Labeling Error

    Angiodynamics is recalling PICC catheters because the stylet diameter may be larger than stated on the label.

    Product
    Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Techn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0710-2017·2016-12-14

    BioFlo PICC Nursing Kits Recalled for Incorrect Glove Expiration Dates

    Angiodynamics is recalling BioFlo PICC Maximal Barrier Nursing Kits because included sterile gloves have incorrect expiration dates.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0708-2017·2016-12-14

    Navilyst Recalls Xcela PICC Kits Due to Incorrect Glove Expiration Dates

    Navilyst Medical is recalling Xcela Power Injectable PICC Maximal Barrier Nursing Kits because included sterile gloves have incorrect expiration dates.

    Product
    Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system
    Category
    Medical Device
    Distribution
    Distributed nationwide