Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported May 1, 2019
Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical activity, (Edi signals) by which the two ventilator modes NAVA and NIV NAVA can be controlled. - Detecting diaphragmatic electrical activity, (Edi signals) by which the respiratory drive from the brain ca
Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
Getinge US Sales LLC recalled Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF … — a low-severity action.
Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF … was recalled by Getinge US Sales LLC in May 1, 2019. Reason: Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes. Check the official notice for the remedy. Verify recall #Z-1221-2019 with the FDA Devices before acting.
The recall
Getinge US Sales LLC issued this low-severity FDA Devices recall — Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes.
- Low
- severity level
- Class III
- classification
- May 1, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1221-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1221-2019) was formally reported on May 1, 2019, with the manufacturer initiating the action on March 20, 2019. It is classified under Low severity (Class III), with a current status of Terminated. Getinge US Sales LLC is listed as the recalling firm, operating out of WAYNE, NJ. Federal records list the affected scope as 17 boxes (5 catheters per box).
The documented reason for this recall is: Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes Distribution data in the federal record shows the product reached: Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO.. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
17 boxes (5 catheters per box)
Related Recalls
6
6 from same agency
Product description
Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical activity, (Edi signals) by which the two ventilator modes NAVA and NIV NAVA can be controlled. - Detecting diaphragmatic electrical activity, (Edi signals) by which the respiratory drive from the brain can be monitored. - administrating nutrition, fluids and medications by the naso-gastricenteric route.
Reason for recall
Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1221-2019 |
| Date reported | May 1, 2019 |
| Date initiated | March 20, 2019 |
| Recalling firm | Getinge US Sales LLC |
| Firm location | WAYNE, NJ |
| Affected scope | 17 boxes (5 catheters per box) |
| Distribution | Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO. |
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-1221-2019) 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? ▼
Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical activity, (Edi signals) by which the two ventilator modes NAVA and NIV NAVA can be controlled. - Detecting diaphragmatic electrical activity, (Edi signals) by which the respiratory drive from the brain can be monitored. - administrating nutrition, fluids and medications by the naso-gastricenteric route.. Recalled by Getinge US Sales LLC. Units affected: 17 boxes (5 catheters per box).
Why was this product recalled? ▼
Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2019. Severity: Low. Recall number: Z-1221-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1221-2019) 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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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 1, 2019.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.