Reported Mar 11, 2026 · Ongoing

Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE,…

Vascutek, Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Vascutek, Ltd. · Newmains Avenue · Inchinnan, N/A · N/A

Is this the product you have?

Gelsoft Plus
REF
- 635024PE
- 631514PE
- 631222PE
- 633008PE
- 633010PE
- 633007PE
- 636010PE
- 632522PE
- 633012PE
- 635018PE
- 631516PE
- 636016PE
- 631220PE
- 631608PE
- 631206PE
- 631407P50E
- 631508PE
- 636008PE
- 636006PE
- 632518PE
- 634008PE
- 634006PE
- 631218PE
- 632211PE
- 634007PE
- 633006PE
- 631506PE
- 632524PE
- 636007PE
- 631512PE
- 636012PE
- 636014PE
- 632211P50E
- 633016PE
- 631407PE
- 631809PE
- 632010PE
- 631608P50E
- 632520PE
- 632412PE
- 631510PE
- 635022PE
- 631224PE
- 632412P50E
- 631507PE
- 633014PE
- 632010P50E
- 635020PE
- 631809P50E. Gelweave
REF
266 of 266 codes
- 736038E
- 736036E
- 736034E
- 736032ST/10DE
- 736032E
- 736030ST/10DE
- 736030E
- 736028ST/10DE
- 736028E
- 736026ST/10DE
- 736026E
- 736024ST/10DE
- 736024E
- 736022ST/10DE
- 736022E
- 736020E
- 736018E
- 736016E
- 736014E
- 736012E
- 736010E
- 736008E
- 736006E
- 735034ST/8AE
- 735034/8RME
- 735034/10SEE
- 735034/10RME
- 735032STE
- 735032ST/8AE
- 735032/8SE
- 735032/8RME
- 735032/10SEE
- 735032/10RME
- 735030STE
- 735030ST/8AE
- 735030/8SE
- 735030/8RME
- 735030/10SEE
- 735030/10RME
- 735028STE
- 735028ST/8AE
- 735028E
- 735028/8SE
- 735028/8RME
- 735028/10RME
- 735026STE
- 735026ST/8AE
- 735026E
- 735026/8SE
- 735026/8RME
- 735026/10RME
- 735024STE
- 735024ST/8AE
- 735024E
- 735024/8SE
- 735024/8RME
- 735024/10SEE
- 735024/10RME
- 735022STE
- 735022E

Lot codes and dates: All Gelsoft Plus devices (any item number ending 'E-B' e.g. 631206PE-B); REF, Item Number
UDI-DI(GTIN)635024PE, 635024PE-B, 5037881166636; 631514PE, 631514PE-B, 5037881166858; 631222PE, 631222PE-B, 5037881166896; 633008PE, 633008PE-B, 5037881166698; 633010PE, 633010PE-B, 5037881166711; 633007PE, 633007PE-B, 5037881166681; 636010PE, 636010PE-B, 5037881166520; 632522PE, 632522PE-B, 5037881166780; 633012PE, 633012PE-B, 5037881166728; 635018PE, 635018PE-B, 5037881166605; 631516PE, 631516PE-B, 5037881166865; 636016PE, 636016PE-B, 5037881166551; 631220PE, 631220PE-B, 5037881166889; 631608PE, 631608PE-B, 5037881166933; 631206PE, 631206PE-B, 5037881166919; 631407P50E, 631407P50E-B, 5037881167008; 631508PE, 631508PE-B, 5037881166827; 636008PE, 636008PE-B, 5037881166513; 636006PE, 636006PE-B, 5037881166063; 632518PE, 632518PE-B, 5037881166759; 634008PE, 634008PE-B, 5037881166667; 634006PE, 634006PE-B, 5037881166643; 631218PE, 631218PE-B, 5037881166872; 632211PE, 632211PE-B, 5037881166971; 634007PE, 634007PE-B, 5037881166650; 633006PE, 633006PE-B, 5037881166674; 631506PE, 631506PE-B, 5037881166803; 632524PE, 632524PE-B, 5037881166797; 636007PE, 636007PE-B, 5037881166506; 631512PE,631512PE-B, 5037881166841; 636012PE, 636012PE-B, 5037881166537; 636014PE, 636014PE-B, 5037881166544; 632211P50E, 632211P50E-B, 5037881167046; 633016PE, 633016PE-B, 5037881166742; 631407PE, 631407PE-B, 5037881166926; 631809PE, 631809PE-B, 5037881166940; 632010PE, 632010PE-B, 5037881166964; 631608P50E, 631608P50E-B, 5037881167015; 632520PE, 632520PE-B, 5037881166773; 632412PE, 632412PE-B, 5037881166988; 631510PE, 631510PE-B, 5037881166834; 635022PE, 635022PE-B, 5037881166629; 631224PE, 631224PE-B, 5037881166902; 632412P50E, 632412P50E-B, 5037881167053; 631507PE, 631507PE-B, 5037881166810; 633014PE, 633014PE-B, 5037881166735; 632010P50E, 632010P50E-B, 5037881167039; 635020PE, 635020PE-B, 5037881166612; 631809P50E, 631809P50E-B, 5037881167022. All Gelweave devices (any item number ending E-B e.g. 7320128/10RMEE-B); REF, Item Number
UDI-DI(GTIN)
896 of 896 codes
736038E
736038E-B
5037881169415
736036E
736036E-B
5037881169408
736034E
736034E-B
5037881169392
736032ST/10DE
736032ST/10DE-B
5037881172620
736032E
736032E-B
5037881169385
736030ST/10DE
736030ST/10DE-B
5037881172637
736030E
736030E-B
5037881169378
736028ST/10DE
736028ST/10DE-B
5037881172644
736028E
736028E-B
5037881169361
736026ST/10DE
736026ST/10DE-B
5037881172651
736026E
736026E-B
5037881169354
736024ST/10DE
736024ST/10DE-B
5037881172668
736024E
736024E-B
5037881169347
736022ST/10DE
736022ST/10DE-B
5037881172675
736022E
736022E-B
5037881169330
736020E
736020E-B
5037881169323
736018E
736018E-B
5037881169316
736016E
736016E-B
5037881114057
736014E
736014E-B
5037881114040
736012E
736012E-B
5037881168548
Amount recalled: 37430

Where it was sold

Why it was recalled

Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE,…

What you should do

Is this the product you have?

Where it was sold

Why it was recalled

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Where it was sold

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