Teleflex Medical Recalls Non-absorbable Steel Sutures for Diameter Defects
Teleflex Medical is recalling specific lots of non-absorbable steel sutures because they did not meet minimum diameter requirements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a physical specification (diameter) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Teleflex Medical is recalling 3,816 units of Monofilament and Multifilament Non-absorbable Steel Sutures. The recall involves specific product codes and lot numbers, including 0520197-2, 29-727, and X-2235.
The products are being recalled because they did not meet minimum diameter requirements. The affected units were distributed worldwide, including in California, Colorado, Florida, Indiana, Kentucky, Massachusetts, New Mexico, Pennsylvania, Canada, Ireland, and Germany.
Healthcare facilities and consumers should stop using the affected sutures and contact Teleflex Medical for instructions on return or replacement.
The recalled product
- Product
- Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5.
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 3,816
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code: 0520197-2
- Lot number: 02H1001071
- Product Code: 29-727
- Lot numbers: 02M1101954
- 02C1201003
- and 02C1201646
- Product Code: 29-7270M4
- Lot number: 02D1100604
- Product Code: 29-7281M4
- Lot number: 02M1002679
- Product Code: E29-5553M4
- Lot number: 02B1300245
- Product Code: E29-7270M4
- Lot number: 02J1001576
- Product Code: E29-7272M4
- Lot number: 02D1003015
- Product Code: E29-727A
- Lot number: 02F1101062
- Product Code: EP4013P
- Lot number: 02L0800898
Distribution
Related recalls
Same manufacturer · Teleflex Medical
See all →- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- ModerateTeleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighTeleflex Medical Recalls Steel Sutures Due to Needle Attachment Strength Defect
FDA (Devices) · 2014-04-02
- HighTeleflex Medical Recalls Non-absorbable Surgical Sutures for Needle Attachment Defect
FDA (Devices) · 2014-04-02
- HighTeleflex Medical Recalls Polypropylene Sutures for Needle Attachment Defect
FDA (Devices) · 2014-04-02
- HighTeleflex Medical Recalls Polyglycolic Acid Sutures for Needle Attachment Defects
FDA (Devices) · 2014-04-02
- HighTeleflex Medical Recalls Non-absorbable Polyamide Surgical Sutures
FDA (Devices) · 2014-04-02
- HighTeleflex Medical Recalls Stainless Steel Sutures Due to Needle Detachment Risk
FDA (Devices) · 2014-05-14