Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 30, 2014
Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract.
Sterility of the product cannot be guaranteed.
Teleflex Medical recalled Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, an… - a moderate-severity action.
Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, an… was recalled by Teleflex Medical in April 30, 2014. Reason: Sterility of the product cannot be guaranteed.. Check the official notice for the remedy. Verify recall #Z-1506-2014 with the FDA Devices before acting.
The recall
Teleflex Medical issued this moderate-severity FDA Devices recall-Sterility of the product cannot be guaranteed..
- Moderate
- severity level
- Class II
- classification
- April 30, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1506-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1506-2014) was formally reported on April 30, 2014, with the manufacturer initiating the action on March 4, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Teleflex Medical is listed as the recalling firm, operating out of Durham, NC. Federal records list the affected scope as 117,801 ea..
The documented reason for this recall is: Sterility of the product cannot be guaranteed. Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) including the states of AL, AK, AR, CA, CO, FL, GA, ID, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, OH, PA, SC, TN, TX, UT, VT, VA, WA, WV, and WI, and the cou…. 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
117,801 ea.
Related Recalls
6
3 from same agency
Product description
Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract.
Reason for recall
Sterility of the product cannot be guaranteed.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1506-2014 |
| Date reported | April 30, 2014 |
| Date initiated | March 4, 2014 |
| Recalling firm | Teleflex Medical |
| Firm location | Durham, NC |
| Affected scope | 117,801 ea. |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AL, AK, AR, CA, CO, FL, GA, ID, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, OH, PA, SC, TN, TX, UT, VT, VA, WA, WV, and WI, and the countries of Algeria, … |
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-1506-2014) 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? ▼
Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract.. Recalled by Teleflex Medical. Units affected: 117,801 ea..
Why was this product recalled? ▼
Sterility of the product cannot be guaranteed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 30, 2014. Severity: Moderate. Recall number: Z-1506-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-USA (nationwide) including the states of AL, AK, AR, CA, CO, FL, GA, ID, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, OH, PA, SC, TN, TX, UT, VT, VA, WA, WV, and WI, and the countries of Algeria, Andorra, Armenia, Argentina, Austria, Australia, Azerbaijan, Belarus, Bermuda, Bahamas, Boliva, Brazil, Canada, Chile, China, Costa Rica, Cyprus, Czechoslovakia, Germany Guatemala, Denmark, Estonia, Egypt, Finland, France, Great Britain, Georgia, Guadeloupe, Greece, Guyana, Curacao, Hungary, Israel, India, Italy, Jordan, Japan, Kuwait, Kazakhstan, Luxembourg, Latvia, Libya, Madagascar, Macedonia, Martinique, Malta, Mauritius, Mexico, Nicaragua, Nigeria, Netherlands, Norway, Oman, Peru, French Polynesia, Poland, Portugal, San Marino, Singapore, Spain, Suriname, San Salvador, Thailand, Tunisia, Turkey, Uruguay, Uzbekistan, Wallis & Futuna Islands, Zambia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1506-2014) 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 April 30, 2014. 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.