Recall archive / FDA device enforcement
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX — FDA record Z-0998-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 20, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX
- Reason
- The product may be shorter than packaging indicates
- Classification
- Class II
- Recalling firm
- Bolton Medical Inc.
- Quantity
- 640 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0998-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDIUDI/DI 00843576100954, REF 28-N4-22-159-22S, Lot Numbers: B210719245, B210619174; UDI/DI 00843576100831, REF 28-N4-24-099-24S, Lot Numbers: B220323028, B211222140; UDI/DI 00843576150423, REF 28-N4-24-099-24U, Lot Numbers: 2204210157, 2204210158, 2208230256, 2208250035; UDI/DI 00843576100961, REF 28-N4-24-159-24S, Lot Numbers: B220104035, B220824113, B210612293, B220201173; UDI/DI 00843576150553, REF 28-N4-24-159-24U, Lot Numbers: 2202090215, 2202090293; UDI/DI 00843576101227, REF 28-N4-24-259-24S, Lot Numbers: B220210257, B220210257; UDI/DI 00843576150812, REF 28-N4-24-259-24U, Lot Numbers: 2210110048, 2210110049, 2210100193; UDI/DI 00843576100848, REF 28-N4-26-104-26S, Lot Numbers: B220226088, B220414055; UDI/DI 00843576150430, REF 28-N4-26-104-26U, Lot Numbers: 2110070047, 2202020135, 2202010164, 2112210201, 2202120154, 2202260085, 2204140202; UDI/DI 00843576100978, REF 28-N4-26-164-26S, Lot Numbers: B220316171, B210927313, B210602367, B220303176, B220316275, B220204220, B220210181, B220210141, B211215127, B220203121; UDI/DI 00843576150560, REF 28-N4-26-164-26U, Lot Numbers: 2110130276, 2203030136, 2203040029, 2206140190, 2202280430, 2203030197, 2202020185, 2202090218, 2202100235; UDI/DI 00843576150690, REF 28-N4-26-204-26U, Lot Numbers: 2201150114, 2204150063, 2206130239; UDI/DI 00843576100855, REF 28-N4-28-104-28S, Lot Numbers: B220323030, B220323295, B221024139, B221026118, B221024275; UDI/DI 00843576150447, REF 28-N4-28-104-28U, Lot Numbers: 2108090034, 2206140194, 2112170035, 2202100079, 2202110166, 2202160141; UDI/DI 00843576150935, REF 28-N4-28-164-24U, Lot Numbers: 2202160143, 2202160143, 220614019; UDI/DI 00843576100985, REF 28-N4-28-164-28S, Lot Numbers: 2202150157, B210713325, B211019291, B211218042, B211217126, B211228051, B211228183, B211019294, B220302187, B220308234, B220308196, B220315291, B220315290, B220316085, B220224046, B211215130, B220211180, B220215104, B220215116, B211218039, B220215116; UDI/DI 00843576150577, REF 28-N4-28-164-28U, Lot Numbers: 2202140139, 2203160088, 2203110300, 2208190099, 2203110300, 2208230038; UDI/DI 00843576101449, REF 28-N4-28-204-24S, Lot Numbers: B220216144; UDI/DI 00843576151031, REF 28-N4-28-204-24U, Lot Numbers: 2203040078, 2203040076; UDI/DI 00843576101111, REF 28-N4-28-204-28S, Lot Numbers: B220222108, B220222103, B220222101, B220216186, B220315302; UDI/DI 00843576150706, REF 28-N4-28-204-28U, Lot Numbers: 2203140261, 2210260120; UDI/DI 00843576100862, REF 28-N4-30-104-30S, Lot Numbers: B220222073, B220613221, B220316226, UDI/DI 00843576150454, REF 28-N4-30-104-30U, Lot Numbers: 2202150087, 2108110152, 2108110159, 2108140005, 2108110132, 2202160183, 2202150087, 2202280426, 2110180211, 2206130118, 2206130220, 2206130222, 2108240015; UDI/DI 00843576101357, REF 28-N4-30-164-26S, Lot Numbers: B220316227, B220224140, B220224216, B220223287, B220224044, B220222297, B220225423; UDI/DI 00843576150942, REF 28-N4-30-164-26U, Lot Numbers: 2203040072, 2110130019, 2110130017, 2203040073, 2110190312, 2208250041, 2112220164, 2201210010, 2202050219, 2202030151, 2210110302, 2205210093; UDI/DI 00843576100992, REF 28-N4-30-164-30S, Lot Numbers: B220324178, B220324178, B220324163, B211012014; UDI/DI 00843576150584, REF 28-N4-30-164-30U, Lot Numbers: 2203010234, 2202230316, 2202250014, 2202280425, 2202180529, 2202220074, 2202220072, 2202220069, 2202180529, 2202220074, 2202220072, 2202220069, 2203020201, 2206130228, 2202140234; UDI/DI 00843576101456, REF 28-N4-30-209-26S, Lot Numbers: B220316255; UDI/DI 00843576151048, REF 28-N4-30-209-26U, Lot Numbers: 2112140027, 2112130022, 2202160146, 2202150163, 2202160145, 2203160257, 2208250012, 2201180076, 2203160257, 2208240034; UDI/DI 00843576101128, REF 28-N4-30-209-30S, Lot Numbers: B220326008, B220222333; UDI/DI 00843576150713, REF 28-N4-30-209-30U, Lot Numbers: 2203160252, 2202220110, 2202220113, 2203160253, 2112210090, 2201040111, 2201180074, 2202140257, 2202100239, 2202110347; UDI/DI 00843576101258, REF 28-N4-30-259-30S, Lot Numbers: B220215153; UDI/DI 00843576100879, REF 28-N4-32-104-32S, Lot Numbers: B220216231, B221021262, B220324319; UDI/DI 00843576150461, REF 28-N4-32-104-32U, Lot Numbers: 2108120046, 2107140315, 2202180555, 2202160240, 2202170062, 2107260368, 2107240008, 2112170233, 2202190002, 2202180531, 2202180555, 2202190002, 2107260364, 2112270017, 2202040221; UDI/DI 00843576101364, REF 28-N4-32-164-28S, Lot Numbers: B220324327, B220822175, B220824051, B220823128, B220824185, B220824144, B211216067, B220325018, B220324175, B220324176, B220825153, B211215259, B220324175, B220324176, B220823156, B220823157; UDI/DI 00843576150959, REF 28-N4-32-164-28U, Lot Numbers: 2203230306, 2210210006, 2210260127, 2202230291, 2202230295; UDI/DI 00843576101005, REF 28-N4-32-164-32S, Lot Numbers: B220325138, B220323296, B220323298, B220613231, B211211183, B211214172, B211211162; UDI/DI 00843576150591, REF 28-N4-32-164-32U, Lot Numbers: 2203250141, 2203230297, 2110060132, 2203030284, 2208240048, 2208250009, 2210250032, 2203080200, 2112110095, 2204010186, 2210250296; UDI/DI 00843576101463, REF 28-N4-32-209-28S, Lot Numbers: B220323320; UDI/DI 00843576151055, REF 28-N4-32-209-28U, Lot Numbers: 2202020166, 2202180572, 2112150321, 2112110166, 2112110165, 2202280418, 2205250253; UDI/DI 00843576101135, REF 28-N4-32-209-32S, Lot Numbers: B220324197, B211214116, B220222117, B220222117; UDI/DI 00843576150720, REF 28-N4-32-209-32U, Lot Numbers: 2203230299, 2204090207, 2112140173, 2208250166, 2208230272; UDI/DI 00843576101562, REF 28-N4-32-259-28S, Lot Numbers: B211012003; UDI/DI 00843576151154, REF 28-N4-32-259-28U, Lot Numbers: 2206130123; UDI/DI 00843576150478, REF 28-N4-34-109-34U, Lot Numbers: 2203080004, 2203100247, 2108210088, 2109030355, 2203080007, 2112210087, 2112210085, 2210110299, 2112110082, 2203080003, 2206130241; UDI/DI 00843576101371, REF 28-N4-34-154-30S, Lot Numbers: B210608025, B211213134, B211214113, B211028048, B211101323, B211220050, B211221096, B220314244; UDI/DI 00843576150966, REF 28-N4-34-154-30U, Lot Numbers: 2203040077, 2203040075, 2204040345, 2110040246, 2202240217, 2204120411, 2112180054, 2112200048, 2210120224, 2202050011; UDI/DI 00843576101012, REF 28-N4-34-154-34S, Lot Numbers: B211221131, B211220039, B210610038; UDI/DI 00843576150607, REF 28-N4-34-154-34U, Lot Numbers: 2203080204, 2202220094, 2109070357, 2109040003, 2108280016, 2107300166, 2107300158, 2202220127, 2202220104, 2202220129, 2109040002, 2112200021, 2112210095, 2201070130, 2202260034, 2202220096, 2202220075, 2202220079, 2202220138, 2202220102, 2201070146, 2202220075, 2202220138, B220315087; UDI/DI 00843576151062, REF 28-N4-34-209-30U, Lot Numbers: 2205250147, 2112200052, 2201190027, 2201180135, 2201310004; UDI/DI 00843576101142, REF 28-N4-34-209-34S, Lot Numbers: B211214294, B220324009, B220324165, B220324181, B220326025, B220324181, B211214174, B220325013, B220329320; UDI/DI 00843576150737, REF 28-N4-34-209-34U, Lot Numbers: 2210260199, 2210260201, 2210260198, 2210260200, 2210260126, 2210260197, 2210260207, 2203090075, 2203100243, 2203250143, 2206140097; UDI/DI 00843576170155, REF 28-N4-34-210-44U, Lot Numbers: 2208240124; UDI/DI 00843576101272, REF 28-N4-34-259-34S, Lot Numbers: B211222139; UDI/DI 00843576150867, REF 28-N4-34-259-34U, Lot Numbers: 2210100114; UDI/DI 00843576100893, REF 28-N4-36-109-36S, Lot Numbers: B211213218, B221007301, B211215203, B220226036, B220228230, B220228434, B220322215, UDI/DI 00843576150485, REF 28-N4-36-109-36U, Lot Numbers: 2107150330, 2107210144, 2107150333, 2112160106; UDI/DI 00843576101388, REF 28-N4-36-154-32S, Lot Numbers: B220825195, B220316259, B220822023, B211221094; UDI/DI 00843576150973, REF 28-N4-36-154-32U, Lot Numbers: 2202140171, 2203100002, 2110060302, 2202170251, 2203080225, 2203080362, 2203030299, 2112100338, 2112150158, 2112150159, 2202150132, 2202140062, 2201200119, 2202140062; UDI/DI 00843576150973, REF 28-N4-36-154-32U, Lot Numbers: 2202120091; UDI/DI 00843576101029, REF 28-N4-36-154-36S, Lot Numbers: B220324164, B211217046, B220825165, B211217043, B220420031, B220415060, B220420032, B220419247; UDI/DI 00843576150614, REF 28-N4-36-154-36U, Lot Numbers: 2202140142, 2202140222, 2202140142, 2202120084, 2108040300, 2108100279, 2110120294, 2202250085, 2204200029, 2204190245, 2204140198, 2204180291, 2201200081; UDI/DI 00843576101487, REF 28-N4-36-199-32S, Lot Numbers: B220420141, B220824035, B220823266, B211217230, B220420142; UDI/DI 00843576151079, REF 28-N4-36-199-32U, Lot Numbers: 2112140115, 2202160005, 2202160147, 2202150173, 2202160062, 2202160192, 2202190003, 2202220342, 2201180071, 2201210202, 2202150173, 2202160192, 2202190003, 2202160147, 2201310240; UDI/DI 00843576101159, REF 28-N4-36-199-36S, Lot Numbers: B220325145, B220316278, B220614146, B220812095, B220824139; UDI/DI 00843576150744, REF 28-N4-36-199-36U, Lot Numbers: 2202160190, 2202170035, 2203030285, 2203250159, 2204200134, 2203080251, 2203020257, 2203040068, 2203160254, 2203160313, 2112180048, 2112200054, 2112200042, 2202120166, 2204200137, 2204200132, 2202120166, 2202170035; UDI/DI 00843576151178, REF 28-N4-36-259-32U, Lot Numbers: 2102240015, 2201170287; UDI/DI 00843576101289, REF 28-N4-36-259-36S, Lot Numbers: B220412367, B220226086; UDI/DI 00843576150492, REF 28-N4-38-109-38U, Lot Numbers: 2201290084, 2107220127, 2112010077, 2107220126; UDI/DI 00843576101395, REF 28-N4-38-154-34S, Lot Numbers: B220329299, B220418293; UDI/DI 00843576150980, REF 28-N4-38-154-34U, Lot Numbers: 2201210011, 2204210129, 2204060407, 2204220290, 2112130021, 2201290305; UDI/DI 00843576101036, REF 28-N4-38-154-38S, Lot Numbers: B220329318, B220420115, B211215133, B211215143, B211215134, B211227031, B220823037; UDI/DI 00843576150621, REF 28-N4-38-154-38U, Lot Numbers: 2110130259, 2201260405, 2110130263, 2110130261, 2110130262, 2204210143, 2208230039, 2208250172, 2201200092, 2201200099, 2201210068, 2201260344, 2205060274; UDI/DI 00843576101494, REF 28-N4-38-199-34S, Lot Numbers: B220414211; UDI/DI 00843576151086, REF 28-N4-38-199-34U, Lot Numbers: 2203030169, 2210260129, 2206130122, 2112220144, 2112150208, 2201180083, 2201180079, 2201180132, 2201210298; UDI/DI 00843576101166, REF 28-N4-38-199-38S, Lot Numbers: B220411209, B220823257, B220614191, B220823260; UDI/DI 00843576150751, REF 28-N4-38-199-38U, Lot Numbers: 2203080257, 2201210100, 2201210117, 2201210186, 2201210057, 2201270226, 2208230274, 2208230124, 2208240033, 2208230258, 2208220167, 2208250078, 2208240184, 2208250152, 2201210157, 2201250164; UDI/DI 00843576101593, REF 28-N4-38-259-34S, Lot Numbers: B220315384; UDI/DI 00843576151185, REF 28-N4-38-259-34U, Lot Numbers: 2108260329; UDI/DI 00843576101296, REF 28-N4-38-259-38S, Lot Numbers: B210609044, B211214297, B220824031; UDI/DI 00843576150881, REF 28-N4-38-259-38U, Lot Numbers: 2203080242, 2108040320, 2204110222, 2204200258; UDI/DI 00843576100916, REF 28-N4-40-114-40S, Lot Numbers: B211220015; UDI/DI 00843576101401, REF 28-N4-40-154-36S, Lot Numbers: B220212187, B211218056, B211221089, B220214225, B220328369; UDI/DI 00843576150997, REF 28-N4-40-154-36U, Lot Numbers: 2203240199, 2203250146, 2201210024, 2201210021, 2201210027, 2201310002; UDI/DI 00843576101043, REF 28-N4-40-154-40S, Lot Numbers: B220328261, B220329007, B220328341, B220124254, B211227044, B220301024; UDI/DI 00843576150638, REF 28-N4-40-154-40U, Lot Numbers: 2201200112, 2205180204, 2204220151, 2204210111, 2204200034, 2204090201, 2201180080, 2201210330, 2203010010, 2204230122, 2201250163; UDI/DI 00843576101500, REF 28-N4-40-204-36S, Lot Numbers: B220324328, B220316279; UDI/DI 00843576151093, REF 28-N4-40-204-36U, Lot Numbers: 2112130223, 2210260205, 2204220084, 2201310010, 2201280055, 2204200217, 2204220085, 2204200140, 2210120145, 2210260204, 2201220095; UDI/DI 00843576101173, REF 28-N4-40-204-40S, Lot Numbers: B220328304, B220328305, B220613305; UDI/DI 00843576150768, REF 28-N4-40-204-40U, Lot Numbers: 2203030296, 2204200040, 2203080217, 2201150117, 2201220082, 2204210012, 2204210125, 2201220134, 2201280513, 2201270355, 2204200039; UDI/DI ... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 25, 2023
- Recall initiation date
- Dec 20, 2022
- Center classification date
- Jan 19, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.