RegWardenFDA facility compliance records
Company

Prytime Medical Devices, Inc.

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2020: 2 recalls20172018201922020202120222023202420252026
  • Recalls (2)

Registered facilities (2)

Recalls & enforcement

  • Class IITerminated2020-12-14
    There is a potential that a catheter convenience set contains a 21G access needle instead of the correct 18G needle. If the 21G needle is used to gain vascular access then the guidewire included in the kit will not pass through the access needle to facilitate insertion of an intr…
  • Class IITerminated2020-10-29
    There is a potential that catheters may have incorrectly marked balloon and arterial lines. This could result in a procedure delay or injury to the patient.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Prytime Medical Devices, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10050783-prytime-medical-devices-inc/

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