Recall archive / FDA device enforcement

Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; ... — FDA record Z-1323-2023

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 Feb 8, 2023. 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: Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110; f) DBM T43101 0.5CC GRAFTON PUTTY, REF T43101; g) DBM T43101INT 0.5CC GRAFTON PUTTY, REF T43101INT; h) DBM T43102 1CC GRAFTON PUTTY, REF T43102; i) DBM T43102INT 1CC GRAFTON PUTTY, REF T43102INT; j) DBM T43102JPN GRAFTON PUTTY 1CC JAR, REF T43102JPN; k) DBM T43103 2.5CC GRAFTON PUTTY, REF T43103; l) DBM T43103INT 2.5CC GRAFTON PUTTY, REF T43103INT; m) DBM T43103JPN GRAFTON PUTTY 2.5CC JAR, REF T43103JPN; n) DBM T43105 5CC GRAFTON PUTTY, REF T43105; o) DBM T43105INT 5CC GRAFTON PUTTY, REF T43105INT; p) DBM T43105JPN GRAFTON PUTTY 5CC JAR, REF T43105JPN; q) DBM T43110 10CC GRAFTON PUTTY, REF T43110; r) DBM T43110INT 10CC GRAFTON PUTTY, REF T43110INT; Demineralized Bone Matrix (DBM) product
Reason: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Classification: Class II
Recalling firm: Medtronic Sofamor Danek USA Inc
Quantity: 186889 units
Agency-reported status: Ongoing
Source record identifier: Z-1323-2023

Open the official record

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	a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101, GTIN 00613994960900, Serial Numbers: A43107, A44312, A44898, A45026, A47094, A48070, A48239, A48726, A54374; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102, GTIN 00613994960894, Serial Numbers: A39801, A40711, A42973, A43546, A44572, A44970, A45136, A45543, A46181, A46352, A46538, A46924, A47103, A47710, A48122, A48391, A50563, A50858, A51802, A52414, A53427, A54070, A54689, A54892; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103, GTIN 00613994960887, Serial Numbers: A39091, A40452, A41163, A41376, A42289, A43008, A43345, A43555, A45523, A45714, A45746, A46289, A47357, A48134, A48230, A50024, A50343, A51014, A53131, A53706, A54060; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105, GTIN 00613994961136, Serial Numbers: A39669, A41187, A41545, A42539, A42923, A43450, A43481, A43500, A43516, A43853, A43932, A43934, A44475, A44665, A44733, A44805, A44986, A45039, A45175, A45282, A45457, A45552, A45556, A45919, A47043, A47390, A47714, A47833, A47885, A48125, A48540, A48816, A49460, A49472, A50596, A51281, A53513, A53897, A54184, A54492, A54615, A54771, A54892, A54982; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110, GTIN 00613994961129, Serial Numbers: A41514, A41616, A42444, A43082, A43201, A43235, A43608, A43805, A43852, A43925, A43955, A44054, A44267, A45150, A45454, A45474, A45680, A46359, A46622, A47260, A47287, A47525, A48070, A48080, A48092, A48565, A49050, A49411, A49520, A49924, A52108, A52214, A52379, A53417, A53518, A54052, A54164, A54172, A54245, A54678, A54994; f) DBM T43101 0.5CC GRAFTON PUTTY, REF T43101, GTIN 00643169123106, Serial Numbers: A38151-037, A38151-038, A38151-039, A38151-040, A38151-041, A38151-042, A38151-043, A38151-045, A38151-049, A38151-050, A38151-051, A38151-052, A38151-053, A38151-054, A38151-055, A38151-056, A38151-057, A38151-058, A38151-059, A38151-060, A38151-061, A38151-062, A38151-063, A38151-064, A38151-065, A38151-066, A38151-067, A38151-068, A38151-069, A38151-070, A38151-071, A38151-072, A38151-073, A38151-074, A38151-075, A38151-076, A38151-077, A38151-078, A38151-079, A38151-080, A38151-081, A38151-083, A38151-084, A38151-085, A38151-086, A38151-087, A38151-088, A38151-089, A38151-090, A38151-091, A38151-092, A38151-093, A38151-094, A38151-095, A38151-096, A38151-097, A38151-098, A38151-099, A38151-100, A38151-101, A38151-102, A38151-103, A38151-104, A38151-105, A38151-106, A38151-107, A38151-108, A38151-109, A38151-110, A38151-111, A38151-112, A38151-113, A38151-114, A38151-115, A38151-116, A38151-117, A38151-118, A40115-037, A40115-038, A40115-039, A40115-040, A40115-041, A40115-042, A40115-043, A40115-044, A40115-045, A40115-046, A40115-047, A40115-048, A40115-049, A40115-050, A40115-051, A40115-052, A40115-053, A40115-054, A40115-055, A40115-056, A40115-057, A40115-058, A40115-059, A40115-060, A40115-061, A40115-062, A40115-063, A40115-065, A40115-066, A40115-067, A40115-068, A40115-069, A40115-070, A40115-071, A40115-072, A40115-073, A40115-074, A40115-075, A40115-076, A40115-077, A40115-078, A40115-079, A40115-080, A40115-081, A40115-082, A40115-083, A40115-084, A40115-085, A40115-086, A40115-087, A40115-088, A40115-089, A40115-090, A40115-091, A40115-092, A40115-093, A40115-094, A40115-095, A40115-096, A40601-011, A40601-012, A40601-013, A40601-014, A40601-015, A40601-016, A40601-017, A40601-018, A40601-019, A40601-020, A40601-021, A40601-022, A40601-023, A40601-024, A40601-025, A40601-026, A41784-098, A41784-099, A41784-100, A41784-101, A41784-102, A41784-103, A41784-104, A41784-105, A41784-106, A41784-107, A41784-108, A41784-109, A41784-110, A41784-111, A41784-112, A41784-113, A41784-114, A41784-115, A41784-116, A41784-117, A41784-118, A41784-119, A41784-122, A41784-123, A41784-124, A41784-125, A41784-126, A41784-127, A41784-128, A41784-129, A41784-130, A41784-131, A41784-132, A41784-133, A41784-134, A41784-135, A41784-136, A41784-137, A41784-138, A41784-139, A41784-140, A41784-141, A41784-142, A41784-143, A41784-144, A41784-145, A41784-146, A41784-147, A41784-148, A41784-149, A41784-150, A41784-151, A41784-152, A41784-153, A41784-154, A41784-155, A41784-156, A41784-157, A41784-158, A41784-159, A41784-160, A41784-161, A41784-162, A41784-163, A41784-164, A41784-165, A41784-166, A41784-167, A41784-168, A41784-169, A41784-170, A41784-171, A41784-172, A41784-173, A41784-174, A41784-175, A41784-176, A41784-177, A41784-178, A41784-179, A41784-180, A41784-181, A41784-182, A41784-183, A41784-184, A41784-185, A41784-186, A41784-187, A41784-188, A41784-189, A41784-190, A41784-191, A41784-192, A41784-193, A41784-194, A41784-195, A41784-196, A41784-197, A41784-198, A41784-199, A41784-200, A41784-201, A41784-202, A41784-203, A41784-204, A41784-205, A41784-206, A41784-207, A41784-208, A41784-209, A41784-210, A41784-211, A41784-212, A41784-213, A41784-214, A41784-215, A41784-216, A41784-217, A41784-218, A41784-219, A41784-220, A41784-221, A41784-222, A41784-223, A41784-224, A41784-225, A41784-226, A41784-227, A41784-228, A41784-230, A41784-231, A41784-232, A41784-233, A41784-234, A41784-235, A41784-236, A41784-237, A41784-238, A41784-239, A41784-240, A41784-241, A41784-242, A41784-243, A41784-244, A41784-245, A41784-246, A42116-102, A42116-103, A42116-104, A42116-105, A42116-106, A42116-107, A42116-108, A42116-109, A42116-110, A42116-111, A42116-112, A42116-113, A42116-114, A42116-115, A42116-116, A42116-117, A42116-118, A42116-119, A42116-120, A42116-121, A42116-122, A42116-123, A42116-124, A42116-125, A42116-126, A42116-127, A42116-128, A42116-129, A42116-130, A42116-131, A42116-132, A42116-133, A42116-134, A42116-135, A42116-136, A42116-137, A42116-138, A42116-139, A42116-140, A42116-141, A42116-142, A42116-143, A42116-144, A42116-145, A42116-146, A42116-147, A42116-148, A42116-149, A42116-150, A42116-151, A42116-152, A42116-153, A42116-155, A42116-156, A42116-157, A42116-158, A42116-159, A42116-160, A42116-161, A42116-162, A42116-163, A42116-164, A42116-165, A42116-166, A42409-021, A42409-022, A42409-023, A42409-024, A42409-025, A42409-026, A42409-027, A42409-028, A42409-029, A42409-030, A42409-031, A42409-032, A42409-033, A42409-034, A42409-035, A42409-036, A42409-037, A42409-038, A42409-039, A42409-040, A42409-041, A42409-042, A42409-043, A42409-044, A42409-045, A42409-046, A42409-047, A42409-048, A42409-049, A42409-050, A42409-051, A42409-052, A42409-053, A42409-054, A42409-055, A42409-056, A42409-057, A42409-058, A42409-059, A42409-060, A42409-061, A42409-062, A42409-063, A42409-064, A42409-065, A42409-066, A42409-067, A42409-068, A42409-069, A42409-070, A42409-071, A42409-072, A42409-073, A42409-074, A42409-075, A42409-076, A42409-077, A42409-078, A42409-079, A42409-080, A42409-081, A42409-082, A42409-083, A42409-084, A42409-085, A42409-087, A42409-088, A42409-089, A42409-090, A42409-091, A42409-092, A42409-093, A42409-094, A42409-095, A42409-096, A42409-097, A42409-098, A42409-099, A42409-100, A42409-101, A42409-102, A42409-103, A42409-104, A42409-105, A42409-106, A42409-107, A42409-108, A42409-109, A42409-110, A42409-111, A42409-112, A42409-113, A42518-011, A42518-012, A42518-013, A42518-014, A42518-015, A42518-016, A42518-017, A42518-018, A42518-019, A42518-020, A42518-021, A42518-022, A42518-023, A42518-024, A42518-025, A42518-026, A42518-027, A42518-028, A42518-029, A42518-030, A42518-031, A42518-032, A42518-033, A42518-034, A42518-035, A42518-036, A42518-037, A42518-038, A42518-039, A42518-040, A42518-041, A42518-042, A42518-043, A42518-044, A42518-045, A42518-046, A42518-047, A42518-048, A42518-049, A42518-050, A42956-011, A42956-012, A42956-013, A42956-014, A42956-015, A42956-016, A42956-017, A42956-018, A42956-019, A42956-020, A42956-021, A42956-022, A42956-023, A42956-024, A42956-025, A42956-026, A42956-027, A42956-028, A42956-029, A42956-030, A42956-031, A42956-032, A43483-011, A43483-012, A43483-013, A43483-014, A43483-015, A43483-016, A43483-017, A43483-018, A43483-019, A43483-020, A43483-021, A43483-022, A43483-023, A43483-024, A43483-025, A43483-026, A43483-027, A43483-028, A43483-029, A43483-030, A43483-031, A43483-032, A43483-033, A43483-034, A43483-035, A43483-036, A43483-037, A43483-038, A43483-039, A43483-040, A43483-041, A43483-042, A43483-043, A43483-044, A43483-045, A43483-046, A43483-047, A43483-048, A43483-049, A43483-050, A43840-011, A43840-012, A43840-013, A43840-014, A43840-015, A43840-016, A43840-017, A43840-018, A43840-019, A43840-020, A43840-021, A43840-022, A43840-023, A43840-024, A43840-025, A43840-026, A43840-027, A43840-028, A43840-029, A43840-030, A43840-031, A43840-032, A43840-033, A43840-034, A43840-035, A43840-036, A43903-090, A43903-091, A43903-092, A43903-093, A43903-094, A43903-095, A43903-096, A43903-097, A43903-098, A43903-099, A43903-100, A43903-101, A43903-102, A43903-103, A43903-104, A43903-105, A43903-106, A43903-107, A43903-108, A43903-109, A43903-110, A43903-111, A43903-112, A43903-113, A43903-114, A43903-115, A43903-116, A43903-117, A43903-118, A43903-119, A43903-120, A43903-121, A43903-122, A43903-123, A43903-124, A43903-125, A43903-126, A43903-127, A43903-128, A43903-129, A43903-130, A43903-131, A43903-132, A43903-133, A43903-134, A43903-135, A43903-136, A43903-137, A43903-138, A43903-139, A43903-140, A43903-141, A43903-142, A43903-143, A43903-144, A43903-145, A43903-146, A43903-147, A43903-148, A43903-149, A43903-150, A43903-151, A43903-152, A43903-153, A43903-154, A43903-155, A43903-156, A43903-157, A43903-158, A43903-159, A43903-160, A43903-161, A43903-162, A43903-163, A43903-164, A43903-165, A43903-166, A43903-167, A43903-168, A43903-169, A43903-170, A43903-171, A43903-172, A43903-173, A43903-174, A43903-175, A43903-176, A43903-177, A43903-178, A43903-179, A43903-180, A43903-181, A43903-182, A43903-183, A43903-184, A43903-185, A43903-186, A43903-187, A43903-188, A43903-189, A43903-190, A43937-056, A43937-057, A43937-058, A43937-059, A43937-060, A43937-061, A43937-062, A43937-063, A43937-064, A43937-065, A43937-066, A43937-067, A43937-068, A43937-069, A43937-070, A43937-071, A43937-072, A43937-073, A43937-074, A43937-075, A43937-076, A43937-077, A43937-078, A43937-079, A43937-080, A43937-081, A43937-082, A43937-083, A43937-084, A43937-085, A43937-086, A43937-087, A43937-088, A43937-089, A43937-090, A43937-091, A43937-092, A43937-093, A43937-094, A43937-095, A43937-096, A43937-097, A43937-098, A43937-099, A43937-100, A43937-101, A43937-102, A43937-103, A43937-104, A43937-105, A43937-106, A43937-107, A43937-108, A43937-109, A43937-110, A43937-111, A43937-112, A43937-113, A43937-114, A43937-115, A43937-116, A43937-117, A43937-118, A43948-059, A43948-060, A43948-061, A43948-062, A43948-063, A43948-064, A43948-065, A43948-066, A43948-067, A43948-068, A43948-069, A43948-070, A43948-071, A43948-072, A43948-073, A43948-074, A43948-075, A43948-076, A43948-077, A43948-078, A43948-079, A43948-080, A43948-081, A43948-082, A43948-083, A43948-084, A43948-085, A43948-086, A43948-087, A43948-088, A43948-089, A43948-090, A43948-091, A43948-092, A43948-093, A43948-094, A43948-095, A43948-096, A43948-097, A43948-098, A43948-099, A43948-100, A43948-101, A43948-102, A43948-103, A43948-104, A43948-105, A43948-106, A43948-107, A43948-108, A43948-109, A43948-110, A43948-111, A43948-112, A43948-113, A43948-114, A43948-115, A43948-116, A43948-117, A43948-118, A44052-011, A44052-012, A44052-013, A44052-014, A44052-015, A44052-016, A44052-017, A44052-018, A44052-019, A44052-020, A44052-022, A44052-023, A44052-024, A44052-025, A44052-026, A44052-027, A44052-028, A44052-029, A44052-030, A44052-035, A44052-036, A44052-037, A44052-038, A44052-040, A44082-011, A44082-013, A44082-014, A44082-015, A44082-016, A44082-017, A44082-018, A44082-019, A44082-020, A44082-021, A44082-022, A44082-023, A44082-024, A44082-025, A44082-026, A44082-027, A44082-028, A44082-029, A44082-030, A44082-031, A44082-032, A44082-033, A44140-011, A44140-012, A44140-013, A44140-014, A44140-015, A44140-016, A44140-017, A44140-018, A44140-019, A44140-020, A44140-021, A44140-022, A44140-023, A44140...

Label field

Details supplied by the agency

Lot, code or applicability

a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101, GTIN 00613994960900, Serial Numbers: A43107, A44312, A44898, A45026, A47094, A48070, A48239, A48726, A54374; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102, GTIN 00613994960894, Serial Numbers: A39801, A40711, A42973, A43546, A44572, A44970, A45136, A45543, A46181, A46352, A46538, A46924, A47103, A47710, A48122, A48391, A50563, A50858, A51802, A52414, A53427, A54070, A54689, A54892; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103, GTIN 00613994960887, Serial Numbers: A39091, A40452, A41163, A41376, A42289, A43008, A43345, A43555, A45523, A45714, A45746, A46289, A47357, A48134, A48230, A50024, A50343, A51014, A53131, A53706, A54060; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105, GTIN 00613994961136, Serial Numbers: A39669, A41187, A41545, A42539, A42923, A43450, A43481, A43500, A43516, A43853, A43932, A43934, A44475, A44665, A44733, A44805, A44986, A45039, A45175, A45282, A45457, A45552, A45556, A45919, A47043, A47390, A47714, A47833, A47885, A48125, A48540, A48816, A49460, A49472, A50596, A51281, A53513, A53897, A54184, A54492, A54615, A54771, A54892, A54982; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110, GTIN 00613994961129, Serial Numbers: A41514, A41616, A42444, A43082, A43201, A43235, A43608, A43805, A43852, A43925, A43955, A44054, A44267, A45150, A45454, A45474, A45680, A46359, A46622, A47260, A47287, A47525, A48070, A48080, A48092, A48565, A49050, A49411, A49520, A49924, A52108, A52214, A52379, A53417, A53518, A54052, A54164, A54172, A54245, A54678, A54994; f) DBM T43101 0.5CC GRAFTON PUTTY, REF T43101, GTIN 00643169123106, Serial Numbers: A38151-037, A38151-038, A38151-039, A38151-040, A38151-041, A38151-042, A38151-043, A38151-045, A38151-049, A38151-050, A38151-051, A38151-052, A38151-053, A38151-054, A38151-055, A38151-056, A38151-057, A38151-058, A38151-059, A38151-060, A38151-061, A38151-062, A38151-063, A38151-064, A38151-065, A38151-066, A38151-067, A38151-068, A38151-069, A38151-070, A38151-071, A38151-072, A38151-073, A38151-074, A38151-075, A38151-076, A38151-077, A38151-078, A38151-079, A38151-080, A38151-081, A38151-083, A38151-084, A38151-085, A38151-086, A38151-087, A38151-088, A38151-089, A38151-090, A38151-091, A38151-092, A38151-093, A38151-094, A38151-095, A38151-096, A38151-097, A38151-098, A38151-099, A38151-100, A38151-101, A38151-102, A38151-103, A38151-104, A38151-105, A38151-106, A38151-107, A38151-108, A38151-109, A38151-110, A38151-111, A38151-112, A38151-113, A38151-114, A38151-115, A38151-116, A38151-117, A38151-118, A40115-037, A40115-038, A40115-039, A40115-040, A40115-041, A40115-042, A40115-043, A40115-044, A40115-045, A40115-046, A40115-047, A40115-048, A40115-049, A40115-050, A40115-051, A40115-052, A40115-053, A40115-054, A40115-055, A40115-056, A40115-057, A40115-058, A40115-059, A40115-060, A40115-061, A40115-062, A40115-063, A40115-065, A40115-066, A40115-067, A40115-068, A40115-069, A40115-070, A40115-071, A40115-072, A40115-073, A40115-074, A40115-075, A40115-076, A40115-077, A40115-078, A40115-079, A40115-080, A40115-081, A40115-082, A40115-083, A40115-084, A40115-085, A40115-086, A40115-087, A40115-088, A40115-089, A40115-090, A40115-091, A40115-092, A40115-093, A40115-094, A40115-095, A40115-096, A40601-011, A40601-012, A40601-013, A40601-014, A40601-015, A40601-016, A40601-017, A40601-018, A40601-019, A40601-020, A40601-021, A40601-022, A40601-023, A40601-024, A40601-025, A40601-026, A41784-098, A41784-099, A41784-100, A41784-101, A41784-102, A41784-103, A41784-104, A41784-105, A41784-106, A41784-107, A41784-108, A41784-109, A41784-110, A41784-111, A41784-112, A41784-113, A41784-114, A41784-115, A41784-116, A41784-117, A41784-118, A41784-119, A41784-122, A41784-123, A41784-124, A41784-125, A41784-126, A41784-127, A41784-128, A41784-129, A41784-130, A41784-131, A41784-132, A41784-133, A41784-134, A41784-135, A41784-136, A41784-137, A41784-138, A41784-139, A41784-140, A41784-141, A41784-142, A41784-143, A41784-144, A41784-145, A41784-146, A41784-147, A41784-148, A41784-149, A41784-150, A41784-151, A41784-152, A41784-153, A41784-154, A41784-155, A41784-156, A41784-157, A41784-158, A41784-159, A41784-160, A41784-161, A41784-162, A41784-163, A41784-164, A41784-165, A41784-166, A41784-167, A41784-168, A41784-169, A41784-170, A41784-171, A41784-172, A41784-173, A41784-174, A41784-175, A41784-176, A41784-177, A41784-178, A41784-179, A41784-180, A41784-181, A41784-182, A41784-183, A41784-184, A41784-185, A41784-186, A41784-187, A41784-188, A41784-189, A41784-190, A41784-191, A41784-192, A41784-193, A41784-194, A41784-195, A41784-196, A41784-197, A41784-198, A41784-199, A41784-200, A41784-201, A41784-202, A41784-203, A41784-204, A41784-205, A41784-206, A41784-207, A41784-208, A41784-209, A41784-210, A41784-211, A41784-212, A41784-213, A41784-214, A41784-215, A41784-216, A41784-217, A41784-218, A41784-219, A41784-220, A41784-221, A41784-222, A41784-223, A41784-224, A41784-225, A41784-226, A41784-227, A41784-228, A41784-230, A41784-231, A41784-232, A41784-233, A41784-234, A41784-235, A41784-236, A41784-237, A41784-238, A41784-239, A41784-240, A41784-241, A41784-242, A41784-243, A41784-244, A41784-245, A41784-246, A42116-102, A42116-103, A42116-104, A42116-105, A42116-106, A42116-107, A42116-108, A42116-109, A42116-110, A42116-111, A42116-112, A42116-113, A42116-114, A42116-115, A42116-116, A42116-117, A42116-118, A42116-119, A42116-120, A42116-121, A42116-122, A42116-123, A42116-124, A42116-125, A42116-126, A42116-127, A42116-128, A42116-129, A42116-130, A42116-131, A42116-132, A42116-133, A42116-134, A42116-135, A42116-136, A42116-137, A42116-138, A42116-139, A42116-140, A42116-141, A42116-142, A42116-143, A42116-144, A42116-145, A42116-146, A42116-147, A42116-148, A42116-149, A42116-150, A42116-151, A42116-152, A42116-153, A42116-155, A42116-156, A42116-157, A42116-158, A42116-159, A42116-160, A42116-161, A42116-162, A42116-163, A42116-164, A42116-165, A42116-166, A42409-021, A42409-022, A42409-023, A42409-024, A42409-025, A42409-026, A42409-027, A42409-028, A42409-029, A42409-030, A42409-031, A42409-032, A42409-033, A42409-034, A42409-035, A42409-036, A42409-037, A42409-038, A42409-039, A42409-040, A42409-041, A42409-042, A42409-043, A42409-044, A42409-045, A42409-046, A42409-047, A42409-048, A42409-049, A42409-050, A42409-051, A42409-052, A42409-053, A42409-054, A42409-055, A42409-056, A42409-057, A42409-058, A42409-059, A42409-060, A42409-061, A42409-062, A42409-063, A42409-064, A42409-065, A42409-066, A42409-067, A42409-068, A42409-069, A42409-070, A42409-071, A42409-072, A42409-073, A42409-074, A42409-075, A42409-076, A42409-077, A42409-078, A42409-079, A42409-080, A42409-081, A42409-082, A42409-083, A42409-084, A42409-085, A42409-087, A42409-088, A42409-089, A42409-090, A42409-091, A42409-092, A42409-093, A42409-094, A42409-095, A42409-096, A42409-097, A42409-098, A42409-099, A42409-100, A42409-101, A42409-102, A42409-103, A42409-104, A42409-105, A42409-106, A42409-107, A42409-108, A42409-109, A42409-110, A42409-111, A42409-112, A42409-113, A42518-011, A42518-012, A42518-013, A42518-014, A42518-015, A42518-016, A42518-017, A42518-018, A42518-019, A42518-020, A42518-021, A42518-022, A42518-023, A42518-024, A42518-025, A42518-026, A42518-027, A42518-028, A42518-029, A42518-030, A42518-031, A42518-032, A42518-033, A42518-034, A42518-035, A42518-036, A42518-037, A42518-038, A42518-039, A42518-040, A42518-041, A42518-042, A42518-043, A42518-044, A42518-045, A42518-046, A42518-047, A42518-048, A42518-049, A42518-050, A42956-011, A42956-012, A42956-013, A42956-014, A42956-015, A42956-016, A42956-017, A42956-018, A42956-019, A42956-020, A42956-021, A42956-022, A42956-023, A42956-024, A42956-025, A42956-026, A42956-027, A42956-028, A42956-029, A42956-030, A42956-031, A42956-032, A43483-011, A43483-012, A43483-013, A43483-014, A43483-015, A43483-016, A43483-017, A43483-018, A43483-019, A43483-020, A43483-021, A43483-022, A43483-023, A43483-024, A43483-025, A43483-026, A43483-027, A43483-028, A43483-029, A43483-030, A43483-031, A43483-032, A43483-033, A43483-034, A43483-035, A43483-036, A43483-037, A43483-038, A43483-039, A43483-040, A43483-041, A43483-042, A43483-043, A43483-044, A43483-045, A43483-046, A43483-047, A43483-048, A43483-049, A43483-050, A43840-011, A43840-012, A43840-013, A43840-014, A43840-015, A43840-016, A43840-017, A43840-018, A43840-019, A43840-020, A43840-021, A43840-022, A43840-023, A43840-024, A43840-025, A43840-026, A43840-027, A43840-028, A43840-029, A43840-030, A43840-031, A43840-032, A43840-033, A43840-034, A43840-035, A43840-036, A43903-090, A43903-091, A43903-092, A43903-093, A43903-094, A43903-095, A43903-096, A43903-097, A43903-098, A43903-099, A43903-100, A43903-101, A43903-102, A43903-103, A43903-104, A43903-105, A43903-106, A43903-107, A43903-108, A43903-109, A43903-110, A43903-111, A43903-112, A43903-113, A43903-114, A43903-115, A43903-116, A43903-117, A43903-118, A43903-119, A43903-120, A43903-121, A43903-122, A43903-123, A43903-124, A43903-125, A43903-126, A43903-127, A43903-128, A43903-129, A43903-130, A43903-131, A43903-132, A43903-133, A43903-134, A43903-135, A43903-136, A43903-137, A43903-138, A43903-139, A43903-140, A43903-141, A43903-142, A43903-143, A43903-144, A43903-145, A43903-146, A43903-147, A43903-148, A43903-149, A43903-150, A43903-151, A43903-152, A43903-153, A43903-154, A43903-155, A43903-156, A43903-157, A43903-158, A43903-159, A43903-160, A43903-161, A43903-162, A43903-163, A43903-164, A43903-165, A43903-166, A43903-167, A43903-168, A43903-169, A43903-170, A43903-171, A43903-172, A43903-173, A43903-174, A43903-175, A43903-176, A43903-177, A43903-178, A43903-179, A43903-180, A43903-181, A43903-182, A43903-183, A43903-184, A43903-185, A43903-186, A43903-187, A43903-188, A43903-189, A43903-190, A43937-056, A43937-057, A43937-058, A43937-059, A43937-060, A43937-061, A43937-062, A43937-063, A43937-064, A43937-065, A43937-066, A43937-067, A43937-068, A43937-069, A43937-070, A43937-071, A43937-072, A43937-073, A43937-074, A43937-075, A43937-076, A43937-077, A43937-078, A43937-079, A43937-080, A43937-081, A43937-082, A43937-083, A43937-084, A43937-085, A43937-086, A43937-087, A43937-088, A43937-089, A43937-090, A43937-091, A43937-092, A43937-093, A43937-094, A43937-095, A43937-096, A43937-097, A43937-098, A43937-099, A43937-100, A43937-101, A43937-102, A43937-103, A43937-104, A43937-105, A43937-106, A43937-107, A43937-108, A43937-109, A43937-110, A43937-111, A43937-112, A43937-113, A43937-114, A43937-115, A43937-116, A43937-117, A43937-118, A43948-059, A43948-060, A43948-061, A43948-062, A43948-063, A43948-064, A43948-065, A43948-066, A43948-067, A43948-068, A43948-069, A43948-070, A43948-071, A43948-072, A43948-073, A43948-074, A43948-075, A43948-076, A43948-077, A43948-078, A43948-079, A43948-080, A43948-081, A43948-082, A43948-083, A43948-084, A43948-085, A43948-086, A43948-087, A43948-088, A43948-089, A43948-090, A43948-091, A43948-092, A43948-093, A43948-094, A43948-095, A43948-096, A43948-097, A43948-098, A43948-099, A43948-100, A43948-101, A43948-102, A43948-103, A43948-104, A43948-105, A43948-106, A43948-107, A43948-108, A43948-109, A43948-110, A43948-111, A43948-112, A43948-113, A43948-114, A43948-115, A43948-116, A43948-117, A43948-118, A44052-011, A44052-012, A44052-013, A44052-014, A44052-015, A44052-016, A44052-017, A44052-018, A44052-019, A44052-020, A44052-022, A44052-023, A44052-024, A44052-025, A44052-026, A44052-027, A44052-028, A44052-029, A44052-030, A44052-035, A44052-036, A44052-037, A44052-038, A44052-040, A44082-011, A44082-013, A44082-014, A44082-015, A44082-016, A44082-017, A44082-018, A44082-019, A44082-020, A44082-021, A44082-022, A44082-023, A44082-024, A44082-025, A44082-026, A44082-027, A44082-028, A44082-029, A44082-030, A44082-031, A44082-032, A44082-033, A44140-011, A44140-012, A44140-013, A44140-014, A44140-015, A44140-016, A44140-017, A44140-018, A44140-019, A44140-020, A44140-021, A44140-022, A44140-023, A44140...

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 Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Apr 12, 2023
Recall initiation date: Feb 8, 2023
Center classification date: Apr 4, 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.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records