Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 19, 2018
Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression and drainage of stomach contents following injury, illness, or surgery in patients with intestinal obstruction, and to prevent the distention of the stomach.
This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Covidien LLC recalled Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 88882649… - a moderate-severity action.
Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 88882649… was recalled by Covidien LLC in December 19, 2018. Reason: This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stom…. Check the official notice for the remedy. Verify recall #Z-0597-2019 with the FDA Devices before acting.
The recall
Covidien LLC issued this moderate-severity FDA Devices recall-This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stom….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- December 19, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0597-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0597-2019) was formally reported on December 19, 2018, with the manufacturer initiating the action on October 31, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Covidien LLC is listed as the recalling firm, operating out of Mansfield, MA. Federal records list the affected scope as 1522.
The documented reason for this recall is: This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr Salem Sump Tube when a 16Fr is nee… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and foreign distribution to Canada.. 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 - 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 - 40,422 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
1522
Related Recalls
6
0 from same agency
Product description
Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression and drainage of stomach contents following injury, illness, or surgery in patients with intestinal obstruction, and to prevent the distention of the stomach.
Reason for recall
This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr Salem Sump Tube when a 16Fr is needed could result in decreased fluid collection, with the potential to affect patient care, particularly in an emergency situation where the correct size is not readily available.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0597-2019 |
| Date reported | December 19, 2018 |
| Date initiated | October 31, 2018 |
| Recalling firm | Covidien LLC |
| Firm location | Mansfield, MA |
| Affected scope | 1522 |
| Distribution | Worldwide Distribution - US Nationwide and foreign distribution to Canada. |
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-0597-2019) 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? ▼
Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression and drainage of stomach contents following injury, illness, or surgery in patients with intestinal obstruction, and to prevent the distention of the stomach.. Recalled by Covidien LLC. Units affected: 1522.
Why was this product recalled? ▼
This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr Salem Sump Tube when a 16Fr is needed could result in decreased fluid collection, with the potential to affect patient care, particularly in an emergency situation where the correct size is not readily available.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 19, 2018. Severity: Moderate. Recall number: Z-0597-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide and foreign distribution to Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0597-2019) 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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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 December 19, 2018. 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.