Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 17, 2017
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580
Product sterility compromised due to breach in sterile barrier package
Mederi Therapeutics, Inc recalled Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERA… - a moderate-severity action.
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERA… was recalled by Mederi Therapeutics, Inc in May 17, 2017. Reason: Product sterility compromised due to breach in sterile barrier package. Check the official notice for the remedy. Verify recall #Z-2050-2017 with the FDA Devices before acting.
The recall
Mederi Therapeutics, Inc issued this moderate-severity FDA Devices recall-Product sterility compromised due to breach in sterile barrier package.
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- May 17, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2050-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2050-2017) was formally reported on May 17, 2017, with the manufacturer initiating the action on April 3, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Mederi Therapeutics, Inc is listed as the recalling firm, operating out of Norwalk, CT. Federal records list the affected scope as 1458 units.
The documented reason for this recall is: Product sterility compromised due to breach in sterile barrier package Distribution data in the federal record shows the product reached: Worldwide Distribution - Nationwide Distribution and to the countries of: Turkey, Great Britain, Belgium, Kuwait, Poland, Italy, India, China, Costa Rica, Australia, Malaysia, Jordan and Egypt.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1458 units
Related Recalls
6
3 from same agency
Product description
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580
Reason for recall
Product sterility compromised due to breach in sterile barrier package
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2050-2017 |
| Date reported | May 17, 2017 |
| Date initiated | April 3, 2017 |
| Recalling firm | Mederi Therapeutics, Inc |
| Firm location | Norwalk, CT |
| Affected scope | 1458 units |
| Distribution | Worldwide Distribution - Nationwide Distribution and to the countries of: Turkey, Great Britain, Belgium, Kuwait, Poland, Italy, India, China, Costa Rica, Australia, Malaysia, Jordan and Egypt. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2050-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580. Recalled by Mederi Therapeutics, Inc. Units affected: 1458 units.
Why was this product recalled? ▼
Product sterility compromised due to breach in sterile barrier package
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 17, 2017. Severity: Moderate. Recall number: Z-2050-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - Nationwide Distribution and to the countries of: Turkey, Great Britain, Belgium, Kuwait, Poland, Italy, India, China, Costa Rica, Australia, Malaysia, Jordan and Egypt..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2050-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 17, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.