Use cautionMedical device recall · FDA · Published October 29, 2020
Prytime Medical ER-Reboa Plus Catheter Recall: Incorrect Balloon Marking Risk
Prytime Medical recalls ER-Reboa Plus Catheters with potential incorrect balloon marking, risking procedure delays or patient injury. Affected units have specific model and lot numbers.
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.
Take action
Contact the company
📍Recalling firmPrytime Medical Devices, Inc.229 N Main St · Boerne, TX 78006-2035
“Prytime Medical ER-Reboa Plus Catheter Recall: Incorrect Balloon Marking Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64048-prytime-medical-er-reboa-plus-catheter-recall-incorrect-balloon-marking. Based on FDA recall #Z-0716-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0716-2021%22&limit=1).
The FDA announced on Oct. 29, 2020, that Prytime Medical Devices, Inc. voluntarily recalled its ER-Reboa Plus Catheter due to potentially incorrect markings on balloon and arterial lines. The agency stated this defect could cause procedure delays or patient injury.
How to tell if you have it
Brand: Prytime Medical
Product: PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS
Lot #: 205936
The hazard
According to the FDA, there is a potential that catheters may have incorrectly marked balloon and arterial lines. This defect could result in a procedure delay or injury to the patient.
Context
GovInfoNow's records show Prytime Medical Devices, Inc. has one other recall on record since Dec. 14, 2020: the Prytime Medical Reboa Catheter Kit Recall regarding wrong needle risk. Other recent recalls of similar products include Microvention Bobby Balloon Guide Catheter Recall (April 30, 2026), Diversatek Viper 3-Stage Balloon Dilator Recall (March 18, 2026), and Medline Medical Procedure Kits Recall (May 4, 2026).
How to tell if you have this one
Check for the model number ER7232PLUS and lot number 205936 on the catheter packaging. The product is intended for emergency use only and requires specific medical training.
Brand
Prytime Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for model number ER7232PLUS and lot number 205936 on the catheter packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of Utah.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0716-2021 (October 29, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0716-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.