Bolton Medical Inc. RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
Brand
Bolton Medical Inc.
Lot Codes / Batch Numbers
UDI/DI 00843576100268: REF 28-M4-22-190-22S, Lot Numbers: B210925203 UDI/DI 00843576149731, REF 28-M4-24-150-24U, Lot Numbers: 2204210015, 2208250004, 2208250003, UDI/DI 00843576149618, REF 28-M4-26-095-26U, Lot Numbers: 2112210189, UDI/DI 00843576149748, REF 28-M4-26-155-26U, Lot Numbers: 2208240053, 2208250164, 2208220204, UDI/DI 00843576100039, REF 28-M4-28-095-28S, Lot Numbers: B220211367, B220129307, B220211163, UDI/DI 00843576149625, REF 28-M4-28-095-28U, Lot Numbers: 2208220081, UDI/DI 00843576150119, REF 28-M4-28-155-24U, Lot Numbers: 2210110060, 2202150279, 2202150279, UDI/DI 00843576100169, REF 28-M4-28-155-28S, Lot Numbers: B220209262, UDI/DI 00843576149755, REF 28-M4-28-155-28U, Lot Numbers: 2208240183, UDI/DI 00843576150218, REF 28-M4-28-195-24U, Lot Numbers: 2202030119, UDI/DI 00843576149885, REF 28-M4-28-195-28U, Lot Numbers: 2109150299, UDI/DI 00843576150317, REF 28-M4-28-250-24U, Lot Numbers: 2202100029, UDI/DI 00843576150010, REF 28-M4-28-250-28U, Lot Numbers: 2202010127, UDI/DI 00843576100046, REF 28-M4-30-095-30S, Lot Numbers: B220228338, UDI/DI 00843576149632, REF 28-M4-30-095-30U, Lot Numbers: 2208240127, 2112140029, 2202070140, UDI/DI 00843576150126, REF 28-M4-30-155-26U, Lot Numbers: 2203080218, UDI/DI 00843576100176, REF 28-M4-30-155-30S, Lot Numbers: B220825157, B211229047, B220211164, B211228037, UDI/DI 00843576149762, REF 28-M4-30-155-30U, Lot Numbers: 2202100215, 2208240129, UDI/DI 00843576100633, REF 28-M4-30-200-26S, Lot Numbers: B220207438, UDI/DI 00843576100305, REF 28-M4-30-200-30S, Lot Numbers: B220118082, UDI/DI 00843576100732, REF 28-M4-30-250-26S, Lot Numbers: B220202152, UDI/DI 00843576150027, REF 28-M4-30-250-30U, Lot Numbers: 2202030116, UDI/DI 00843576100053, REF 28-M4-32-095-32S, Lot Numbers: B210910015, UDI/DI 00843576100541, REF 28-M4-32-155-28S, Lot Numbers: B220301231, UDI/DI 00843576100183, REF 28-M4-32-155-32S, Lot Numbers: B220216239, UDI/DI 00843576149779, REF 28-M4-32-155-32U, Lot Numbers: 2202100265, 2202110370, UDI/DI 00843576100640, REF 28-M4-32-200-28S, Lot Numbers: B210626308, B210626307, UDI/DI 00843576100749, REF 28-M4-32-250-28S, Lot Numbers: B211222146, UDI/DI 00843576150331, REF 28-M4-32-250-28U, Lot Numbers: 2110120002, UDI/DI 00843576150034, REF 28-M4-32-250-32U, Lot Numbers: 2112180035, UDI/DI 00843576149656, REF 28-M4-34-100-34U, Lot Numbers: 2112110191, 2202120100, 2208230097, UDI/DI 00843576100558, REF 28-M4-34-145-30S, Lot Numbers: B210609033, UDI/DI 00843576150140, REF 28-M4-34-145-30U, Lot Numbers: 2210110037, UDI/DI 00843576100190, REF 28-M4-34-145-34S, Lot Numbers: B220210184, B211012027, B220210028, B220216053, B220216053, B220209191, UDI/DI 00843576149786, REF 28-M4-34-145-34U, Lot Numbers: 2110120028, 2109150326, 2109140012, 2110120025, 2208240141, 2208240140, 2208240126, 2208240029, 2208240030, 2208250006, 2208250005, 2112280069, 2201280546, 2202080066, UDI/DI 00843576100657, REF 28-M4-34-200-30S, Lot Numbers: B210430260, B220217323, B220216055, B220217319, B211222145, B220216055, B210430262, B220216054, UDI/DI 00843576150249, REF 28-M4-34-200-30U, Lot Numbers: 2202260090, UDI/DI 00843576100329, REF 28-M4-34-200-34S, Lot Numbers: B210428257, B211014252, UDI/DI 00843576149915, REF 28-M4-34-200-34U, Lot Numbers: 2202170286, 2202170286, 2202170219, 2202170278, 2202160200, 2202160200, UDI/DI 00843576100756, REF 28-M4-34-250-30S, Lot Numbers: B211221199, UDI/DI 00843576100077, REF 28-M4-36-100-36S, Lot Numbers: B220217276, B220217276, UDI/DI 00843576100206, REF 28-M4-36-145-36S, Lot Numbers: B221025248, UDI/DI 00843576100664, REF 28-M4-36-190-32S, Lot Numbers: B210622126, B221025300, UDI/DI 00843576100763, REF 28-M4-36-250-32S, Lot Numbers: B221007313, UDI/DI 00843576150058, REF 28-M4-36-250-36U, Lot Numbers: 2210110276, 2210100191, UDI/DI 00843576100084, REF 28-M4-38-100-38S, Lot Numbers: B220824128, UDI/DI 00843576150164, REF 28-M4-38-145-34U, Lot Numbers: 2202170235, UDI/DI 00843576100213, REF 28-M4-38-145-38S, Lot Numbers: B221026208, UDI/DI 00843576100671, REF 28-M4-38-190-34S, Lot Numbers: B220121067, B220317294, UDI/DI 00843576150263, REF 28-M4-38-190-34U, Lot Numbers: 2204140072, UDI/DI 00843576100473, REF 28-M4-38-250-38S, Lot Numbers: B220825007, UDI/DI 00843576100091, REF 28-M4-40-105-40S, Lot Numbers: B220216195, B220216195, B220125193, UDI/DI 00843576149687, REF 28-M4-40-105-40U, Lot Numbers: 2202160194, UDI/DI 00843576100589, REF 28-M4-40-145-36S, Lot Numbers: B220825008, UDI/DI 00843576100350, REF 28-M4-40-195-40S, Lot Numbers: B220222125, B220222125, B220216224, B220223318, B220223318, B220216224, UDI/DI 00843576100787, REF 28-M4-40-250-36S, Lot Numbers: B221025298, UDI/DI 00843576150379, REF 28-M4-40-250-36U, Lot Numbers: 2203010243, UDI/DI 00843576149694, REF 28-M4-42-105-42U, Lot Numbers: 2109100260, UDI/DI 00843576100596, REF 28-M4-42-150-38S, Lot Numbers: B220115098, UDI/DI 00843576100695, REF 28-M4-42-195-38S, Lot Numbers: B220420138, UDI/DI 00843576149700, REF 28-M4-44-105-44U, Lot Numbers: 2201170430, UDI/DI 00843576100602, REF 28-M4-44-155-40S, Lot Numbers: B220117359, UDI/DI 00843576100701, REF 28-M4-44-200-40S, Lot Numbers: B220121070, UDI/DI 00843576100374, REF 28-M4-44-200-44S, Lot Numbers: B220824149, B211229052, B220115095, UDI/DI 00843576150393, REF 28-M4-44-250-40U, Lot Numbers: 2201170418, UDI/DI 00843576150096, REF 28-M4-44-250-44U, Lot Numbers: 2112130139, UDI/DI 00843576100121, REF 28-M4-46-105-46S, Lot Numbers: B211203109, UDI/DI 00843576149717, REF 28-M4-46-105-46U, Lot Numbers: 2203030290, UDI/DI 00843576100718, REF 28-M4-46-200-42S, Lot Numbers: B220825037, UDI/DI 00843576100381, REF 28-M4-46-200-46S, Lot Numbers: B220825038, UDI/DI 00843576149977, REF 28-M4-46-200-46U, Lot Numbers: 2204200130, UDI/DI 00843576100510, REF 28-M4-46-250-46S, Lot Numbers: B210525287.
Products Sold
UDI/DI 00843576100268: REF 28-M4-22-190-22S, Lot Numbers: B210925203 UDI/DI 00843576149731, REF 28-M4-24-150-24U, Lot Numbers: 2204210015, 2208250004, 2208250003; UDI/DI 00843576149618, REF 28-M4-26-095-26U, Lot Numbers: 2112210189; UDI/DI 00843576149748, REF 28-M4-26-155-26U, Lot Numbers: 2208240053, 2208250164, 2208220204; UDI/DI 00843576100039, REF 28-M4-28-095-28S, Lot Numbers: B220211367, B220129307, B220211163; UDI/DI 00843576149625, REF 28-M4-28-095-28U, Lot Numbers: 2208220081; UDI/DI 00843576150119, REF 28-M4-28-155-24U, Lot Numbers: 2210110060, 2202150279, 2202150279; UDI/DI 00843576100169, REF 28-M4-28-155-28S, Lot Numbers: B220209262; UDI/DI 00843576149755, REF 28-M4-28-155-28U, Lot Numbers: 2208240183; UDI/DI 00843576150218, REF 28-M4-28-195-24U, Lot Numbers: 2202030119; UDI/DI 00843576149885, REF 28-M4-28-195-28U, Lot Numbers: 2109150299; UDI/DI 00843576150317, REF 28-M4-28-250-24U, Lot Numbers: 2202100029; UDI/DI 00843576150010, REF 28-M4-28-250-28U, Lot Numbers: 2202010127; UDI/DI 00843576100046, REF 28-M4-30-095-30S, Lot Numbers: B220228338; UDI/DI 00843576149632, REF 28-M4-30-095-30U, Lot Numbers: 2208240127, 2112140029, 2202070140; UDI/DI 00843576150126, REF 28-M4-30-155-26U, Lot Numbers: 2203080218; UDI/DI 00843576100176, REF 28-M4-30-155-30S, Lot Numbers: B220825157, B211229047, B220211164, B211228037; UDI/DI 00843576149762, REF 28-M4-30-155-30U, Lot Numbers: 2202100215, 2208240129; UDI/DI 00843576100633, REF 28-M4-30-200-26S, Lot Numbers: B220207438; UDI/DI 00843576100305, REF 28-M4-30-200-30S, Lot Numbers: B220118082; UDI/DI 00843576100732, REF 28-M4-30-250-26S, Lot Numbers: B220202152; UDI/DI 00843576150027, REF 28-M4-30-250-30U, Lot Numbers: 2202030116; UDI/DI 00843576100053, REF 28-M4-32-095-32S, Lot Numbers: B210910015; UDI/DI 00843576100541, REF 28-M4-32-155-28S, Lot Numbers: B220301231; UDI/DI 00843576100183, REF 28-M4-32-155-32S, Lot Numbers: B220216239; UDI/DI 00843576149779, REF 28-M4-32-155-32U, Lot Numbers: 2202100265, 2202110370; UDI/DI 00843576100640, REF 28-M4-32-200-28S, Lot Numbers: B210626308, B210626307; UDI/DI 00843576100749, REF 28-M4-32-250-28S, Lot Numbers: B211222146; UDI/DI 00843576150331, REF 28-M4-32-250-28U, Lot Numbers: 2110120002; UDI/DI 00843576150034, REF 28-M4-32-250-32U, Lot Numbers: 2112180035; UDI/DI 00843576149656, REF 28-M4-34-100-34U, Lot Numbers: 2112110191, 2202120100, 2208230097; UDI/DI 00843576100558, REF 28-M4-34-145-30S, Lot Numbers: B210609033; UDI/DI 00843576150140, REF 28-M4-34-145-30U, Lot Numbers: 2210110037; UDI/DI 00843576100190, REF 28-M4-34-145-34S, Lot Numbers: B220210184, B211012027, B220210028, B220216053, B220216053, B220209191; UDI/DI 00843576149786, REF 28-M4-34-145-34U, Lot Numbers: 2110120028, 2109150326, 2109140012, 2110120025, 2208240141, 2208240140, 2208240126, 2208240029, 2208240030, 2208250006, 2208250005, 2112280069, 2201280546, 2202080066; UDI/DI 00843576100657, REF 28-M4-34-200-30S, Lot Numbers: B210430260, B220217323, B220216055, B220217319, B211222145, B220216055, B210430262, B220216054; UDI/DI 00843576150249, REF 28-M4-34-200-30U, Lot Numbers: 2202260090; UDI/DI 00843576100329, REF 28-M4-34-200-34S, Lot Numbers: B210428257, B211014252; UDI/DI 00843576149915, REF 28-M4-34-200-34U, Lot Numbers: 2202170286, 2202170286, 2202170219, 2202170278, 2202160200, 2202160200; UDI/DI 00843576100756, REF 28-M4-34-250-30S, Lot Numbers: B211221199; UDI/DI 00843576100077, REF 28-M4-36-100-36S, Lot Numbers: B220217276, B220217276; UDI/DI 00843576100206, REF 28-M4-36-145-36S, Lot Numbers: B221025248; UDI/DI 00843576100664, REF 28-M4-36-190-32S, Lot Numbers: B210622126, B221025300; UDI/DI 00843576100763, REF 28-M4-36-250-32S, Lot Numbers: B221007313; UDI/DI 00843576150058, REF 28-M4-36-250-36U, Lot Numbers: 2210110276, 2210100191; UDI/DI 00843576100084, REF 28-M4-38-100-38S, Lot Numbers: B220824128; UDI/DI 00843576150164, REF 28-M4-38-145-34U, Lot Numbers: 2202170235; UDI/DI 00843576100213, REF 28-M4-38-145-38S, Lot Numbers: B221026208; UDI/DI 00843576100671, REF 28-M4-38-190-34S, Lot Numbers: B220121067, B220317294; UDI/DI 00843576150263, REF 28-M4-38-190-34U, Lot Numbers: 2204140072; UDI/DI 00843576100473, REF 28-M4-38-250-38S, Lot Numbers: B220825007; UDI/DI 00843576100091, REF 28-M4-40-105-40S, Lot Numbers: B220216195, B220216195, B220125193; UDI/DI 00843576149687, REF 28-M4-40-105-40U, Lot Numbers: 2202160194; UDI/DI 00843576100589, REF 28-M4-40-145-36S, Lot Numbers: B220825008; UDI/DI 00843576100350, REF 28-M4-40-195-40S, Lot Numbers: B220222125, B220222125, B220216224, B220223318, B220223318, B220216224; UDI/DI 00843576100787, REF 28-M4-40-250-36S, Lot Numbers: B221025298; UDI/DI 00843576150379, REF 28-M4-40-250-36U, Lot Numbers: 2203010243; UDI/DI 00843576149694, REF 28-M4-42-105-42U, Lot Numbers: 2109100260; UDI/DI 00843576100596, REF 28-M4-42-150-38S, Lot Numbers: B220115098; UDI/DI 00843576100695, REF 28-M4-42-195-38S, Lot Numbers: B220420138; UDI/DI 00843576149700, REF 28-M4-44-105-44U, Lot Numbers: 2201170430; UDI/DI 00843576100602, REF 28-M4-44-155-40S, Lot Numbers: B220117359; UDI/DI 00843576100701, REF 28-M4-44-200-40S, Lot Numbers: B220121070; UDI/DI 00843576100374, REF 28-M4-44-200-44S, Lot Numbers: B220824149, B211229052, B220115095; UDI/DI 00843576150393, REF 28-M4-44-250-40U, Lot Numbers: 2201170418; UDI/DI 00843576150096, REF 28-M4-44-250-44U, Lot Numbers: 2112130139; UDI/DI 00843576100121, REF 28-M4-46-105-46S, Lot Numbers: B211203109; UDI/DI 00843576149717, REF 28-M4-46-105-46U, Lot Numbers: 2203030290; UDI/DI 00843576100718, REF 28-M4-46-200-42S, Lot Numbers: B220825037; UDI/DI 00843576100381, REF 28-M4-46-200-46S, Lot Numbers: B220825038; UDI/DI 00843576149977, REF 28-M4-46-200-46U, Lot Numbers: 2204200130; UDI/DI 00843576100510, REF 28-M4-46-250-46S, Lot Numbers: B210525287.
Bolton Medical Inc. is recalling RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX due to The product may be shorter than packaging indicates. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product may be shorter than packaging indicates
Recommended Action
Per FDA guidance
On 12/15/2022, Terumo Aortic/Bolton Medical, Inc. issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees by mail. The notice explained the problem and the risk, and requested the return of the device to a Terumo Sales Representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026