Teleflex Medical recalls Simplastic suprapubic puncture instruments with latex that may cause allergic reactions. Affected products include specific model codes and batch numbers. Consumers should check packaging for the allergy warning.
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
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📍Recalling firmTeleflex Medical Europe LtdIda Business Park · Athlone, Ireland
✎ GovInfoNow plain-language explainer
Teleflex Medical is recalling Simplastic suprapubic puncture instruments that contain latex but lack a warning label about potential allergic reactions. This recall affects medical devices used for emergency bladder drainage in hospitals and clinics. The hazard is a risk of allergic reactions in sensitive individuals, which could lead to serious health issues if they have latex allergies. Read more at govinfonow.com/recall/71705-teleflex-medical-simplastic-suprapubic-puncture-instruments-recall-latex-allergy-risk.
“Teleflex Medical: Simplastic Suprapubic Puncture Instruments Recall - Latex Allergy Risk.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71705-teleflex-medical-simplastic-suprapubic-puncture-instruments-recall-latex-allergy-risk. Based on FDA recall #Z-1369-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1369-2018%22&limit=1).
The FDA announced on March 15, 2018, that Teleflex Medical Europe Ltd is recalling Simplastic Suprapubic Puncture Instruments because they contain latex without the required warning label. The agency said the products pose an allergic reaction risk to users.
The instruments contain latex but lack the mandatory caution statement regarding natural rubber latex that may cause allergic reactions. The FDA said this missing label creates a risk of allergic reaction for patients.
Context
GovInfoNow's records show Teleflex Medical Europe Ltd has had four other recalls since March 19, 2018, including a July 16, 2021 recall of RUSCH Endotracheal Tubes and a June 12, 2018 recall of Universal Shears. Other recent recalls of similar products include the Stryker NICO BrainPath Shephard's Hook Recall (Oct. 31, 2025), the GRI Medical Laparoscopy Pack Contains Latex Catheter - Recall (Aug. 26, 2026), and the Stryker NICO Myriad Handpieces Recall (Oct. 31, 2025).
How to tell if you have this one
Check the product packaging for the model codes: (a) 650704100/551310, (b) 650704120/551312, or (c) 650704160/551316. Also look for batch numbers listed in the recall notice.
Brand
Teleflex Medical
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1369-2018 (March 15, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1369-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.