The Recall Desk

Hazard

Procedural Failure recalls

8 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
8
Critical
0
Severe
0
Most recent
2024-03-27

Of the 8 procedural failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all procedural failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–8 of 8

  • HighFDA (Devices)·Z-1343-2024·2024-03-27

    Vascular Guidewire Introducer Sheath Recalled for Internal Hub Defect

    Angiodynamics recalls 130 MINI STICK MAX guidewire introducers due to hub voids that may prevent guidewire passage during vascular procedures. No injuries reported.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1501-2021·2021-05-05

    Nextremity Solutions Recalls InCore Lapidus Disposable Kits Due to Drill Bushing Defect

    Nextremity Solutions is recalling 123 units of InCore Lapidus Disposable Kits because a drill bushing defect may prevent surgeons from completing the intended procedure.

    Product
    InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2986-2020·2020-09-30

    LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure

    LivaNova is recalling 102 Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter, preventing implantation.

    Product
    Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2984-2020·2020-09-30

    LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure

    LivaNova is recalling 77 Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter during implantation.

    Product
    Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, all
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0415-2020·2019-11-27

    Cook Inc. Recalls Guardia Access Nano Embryo Transfer Catheters

    Cook Inc. is recalling 202 units of the Guardia Access Nano Embryo Transfer Catheter because bent tips may prevent insertion into the guiding catheter.

    Product
    Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1344-2016·2016-04-13

    AngioDynamics Recalls Renown Regional Medical Center Convenience Kits

    AngioDynamics is recalling 100 Renown Regional Medical Center Convenience Kits because the needle inner lumen is too small to accept the intended guidewire.

    Product
    NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box of 30 pieces, box label contains UPN Product No. H965652300291 Product Usage - This needle is intended to be placed over the guidewire to e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1240-2013·2013-05-15

    Smiths Medical Recalls Sure-Pro Ultra Embryo Replacement Catheters

    Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro Ultra Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1244-2013·2013-05-15

    Smiths Medical Recalls Wallace Sure-Pro Embryo Replacement Catheters

    Smiths Medical ASD, Inc. is recalling 800 Wallace Sure-Pro Single Stage Embryo Replacement Catheters because the catheter cannot be passed through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro¿ Single Stage Embryo Replacement Catheter Product Code: PP623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the adde
    Category
    Medical Device
    Distribution
    Distributed nationwide