Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
BLOM-SINGER indwelling TEP Occluder Recalled by Helix Medical LLC Due to Helix Medical LLC is recalling the BLOM-SINGER indwelling...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Helix Medical LLC directly.
Affected Products
BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.
Quantity: 2 devices
Why Was This Recalled?
Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Helix Medical LLC
Helix Medical LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report