The Recall Desk

Manufacturer

Prytime Medical Devices, Inc.

2 recalls in our database name Prytime Medical Devices, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2021-02-17

Of the 2 recalls from Prytime Medical Devices, Inc. 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 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.

1–2 of 2

  • HighFDA (Devices)·Z-0959-2021·2021-02-17

    Prytime Medical REBOA Catheter Introducer Kit Recalled for Incorrect Needle Size

    Prytime Medical Devices is recalling REBOA Catheter Introducer Kits because they may contain a 21G needle instead of the correct 18G needle, which could cause procedure delays or injury.

    Product
    PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0716-2021·2020-12-30

    PryTime Medical Recalls ER-Reboa Plus Catheters Due to Marking Errors

    PryTime Medical is recalling 3 units of ER-Reoba Plus Catheters because they may have incorrect balloon and arterial line markings, which could delay procedures or injure patients.

    Product
    PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for temporary occlusion of large vessels and blood pressure monitoring including patien
    Category
    Medical Device
    Distribution
    Distributed nationwide