Recall archive / FDA device enforcement

Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206... — FDA record Z-1332-2023

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 Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; 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: 3037 units
Agency-reported status: Ongoing
Source record identifier: Z-1332-2023

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) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203, GTIN 00763000244705, Serial Numbers: A45206-011, A45206-012, A45206-013, A45206-014, A45206-016, A45206-018, A45206-019, A45206-020, A45206-021, A45206-022, A45206-023, A45206-024, A45206-025, A45206-026, A45206-027, A45206-028, A45206-029, A45206-030, A45206-031, A45206-032, A45206-033, A45206-034, A45206-035, A45206-036, A45206-037, A45206-038, A45206-040, A45206-041, A45206-042, A45206-043, A45206-045, A45206-046, A45206-047, A45206-048, A45206-049, A45206-050, A45206-051, A45206-052, A45206-053, A45206-054, A45206-055, A45206-056, A45206-057, A45206-058, A45206-061, A45206-063, A45206-064, A45206-066, A45206-067, A45206-068, A45206-069, A45206-070, A45206-071, A45206-072, A45489-011, A45489-012, A45489-015, A45489-016, A45489-017, A45489-021, A45489-022, A45489-023, A45489-024, A45489-025, A45489-026, A45489-027, A45489-028, A45489-030, A45489-032, A45489-036, A45489-037, A45489-038, A45489-039, A45489-040, A45489-041, A45489-042, A45489-045, A45489-046, A45489-047, A45489-048, A45489-049, A45489-050, A45489-051, A45870-011, A45870-012, A45870-013, A45870-014, A45870-015, A45870-016, A45870-017, A45870-018, A45870-019, A45870-020, A45870-021, A45870-022, A45870-023, A45870-025, A45870-026, A45870-027, A45870-032, A45870-033, A45870-036, A45870-038, A45870-039, A45870-040, A45870-041, A45870-042, A45870-043, A45870-044, A45870-045, A45870-046, A45870-047, A46716-036, A46716-037, A46716-038, A46716-039, A46716-040, A46716-041, A46716-042, A46716-044, A46716-046, A46716-047, A46716-048, A46716-051, A46716-054, A46716-055, A46716-056, A46716-057, A46716-058, A46716-060, A46716-061, A46716-062, A46716-065, A46716-066, A46716-067, A46716-069, A46716-070, A46716-071, A46716-072, A46716-073, A46716-074, A46716-075, A46716-076, A46716-080, A46716-081, A46716-082, A46716-083, A46716-084, A46716-085, A46716-086, A46716-087, A46716-088, A46716-089, A46716-090, A46716-091, A46716-092, A46716-093, A46716-094, A46716-095, A46716-096, A46716-107, A48729-045, A49241-011, A49241-012, A49241-013, A49241-014, A49241-016, A49241-017, A49241-018, A49241-019, A49241-020, A49241-021, A49241-022, A49241-023, A49241-024, A49241-025, A49241-026, A49241-027, A49241-028, A49241-029, A49241-030, A49241-031, A49241-032, A49241-033, A49241-034, A49241-035, A49241-036, A49241-037, A49241-038, A49241-039, A49241-040, A49241-041, A49241-042, A49241-043, A49241-044, A49241-045, A49241-046, A49241-047, A49241-048, A49241-049, A49241-050, A49241-051, A49241-052, A49241-053, A49241-054, A49241-055, A49241-056, A49241-057, A49241-058, A49241-059, A49241-060, A49241-061, A49241-062, A49241-063, A49241-064, A49241-065, A49241-067, A49241-068, A49241-069, A49241-070, A49241-071, A49241-072, A49241-073, A49241-074, A49241-076, A49241-078, A49241-079, A49241-080, A49241-081, A49241-082, A49241-083, A49241-084, A49241-086, A49241-088, A49241-089, A49241-090, A49241-091, A49241-093, A49241-095, A49241-096, A49241-098, A49241-099, A49241-100, A49241-101, A49241-102, A49241-103, A49241-104, A49241-105, A49555-011, A49555-012, A49555-013, A49555-014, A49555-022, A49555-024, A49555-026, A49555-027, A49555-028, A49555-029, A49555-030, A49555-031, A49555-032, A49555-035, A49818-011, A49818-012, A49818-013, A49818-014, A49818-015, A49818-016, A49818-017, A49818-018, A49818-020, A49818-022, A49818-023, A49818-025, A49818-026, A49818-027, A49818-028, A49818-029, A49818-030, A49818-031, A49818-032, A49818-034, A49818-035, A49818-036, A49818-037, A49818-038, A49818-039, A49818-040, A49818-041, A49818-042, A49818-043, A49818-044, A49818-045, A49818-048, A49818-049, A49818-050, A49818-051, A49818-052, A49818-053, A49818-054, A49818-055, A49818-056, A49818-057, A49818-058, A49818-059, A49818-060, A49818-061, A49818-062, A49818-063, A49818-064, A49818-065, A49818-066, A49818-067, A49818-068, A49818-069, A49818-071, A49818-072, A49818-073, A49818-074, A49818-075, A49818-076, A49818-077, A49818-079, A49818-080, A49818-081, A49818-082, A49818-083, A49818-084, A49818-085, A49818-086, A49818-087, A49818-088, A49818-089, A49818-090, A49818-091, A49818-092, A49818-093, A49818-094, A49818-095, A49818-096, A49818-097, A49818-098, A49818-099, A49818-100, A49818-101, A50197-011, A50197-014, A50197-015, A50197-017, A50197-018, A50197-019, A50197-020, A50197-021, A50197-022, A50197-024, A50197-025, A50197-026, A50197-027, A50197-028, A50197-029, A50197-030, A50197-031, A50197-032, A50197-033, A50197-034, A50197-035, A50197-036, A50197-037, A50197-038, A50197-039, A50197-040, A50197-041, A50197-042, A50197-043, A50197-047, A50197-048, A50197-049, A50197-050, A50197-051, A50197-052, A50197-053, A50197-054, A50197-055, A50197-056, A50197-057, A50197-058, A50197-059, A50197-060, A50197-061, A50197-062, A50197-063, A50197-064, A50197-065, A50197-066, A50197-067, A50197-068, A50197-069, A50197-070, A50197-071, A50197-072, A50197-073, A50197-074, A50197-075, A50197-076, A50197-077, A50197-078, A50197-079; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206, GTIN 00763000244712, Serial Numbers: A42287-087, A42287-088, A42287-089, A42287-090, A42287-092, A42287-093, A42287-094, A42287-095, A42287-100, A42287-101, A42287-102, A42287-103, A42287-104, A42287-105, A42287-108, A42287-112, A42287-113, A42287-114, A42287-116, A42287-117, A42287-118, A42287-119, A42287-121, A42287-122, A42287-123, A42287-124, A42287-125, A42287-126, A42287-160, A42287-161, A42287-162, A42287-163, A42287-164, A42287-165, A42287-166, A42287-167, A45179-026, A45179-027, A45179-028, A45179-029, A45179-030, A45179-031, A45179-032, A45179-033, A45179-034, A45179-036, A45179-037, A45179-038, A45179-039, A45179-040, A45179-041, A45179-042, A45179-043, A45179-044, A45179-045, A45179-046, A45179-047, A45179-048, A45179-051, A45179-052, A45179-054, A45179-055, A45179-056, A45179-057, A45179-058, A45179-059, A45179-060, A45179-061, A45179-062, A45179-063, A45179-064, A45492-013, A45492-014, A45492-015, A45492-016, A45492-017, A45492-019, A45492-020, A45492-023, A45492-024, A45492-025, A45492-026, A45492-027, A45492-028, A45492-029, A45492-031, A45492-032, A45492-033, A45492-038, A45492-039, A45492-040, A45492-041, A45492-042, A45492-043, A45492-045, A45492-046, A45492-047, A45492-048, A45492-049, A45492-050, A45492-051, A45492-052, A45492-053, A45492-054, A45492-057, A45492-058, A45492-060, A45492-062, A45492-063, A45492-064, A45492-065, A45492-066, A45492-068, A45492-070, A45492-071, A45492-072, A45492-073, A45492-074, A45492-075, A45492-076, A45492-077, A45492-078, A45492-079, A45492-080, A45492-081, A45492-084, A45492-085, A45492-086, A45492-091, A45492-092, A45492-096, A45492-097, A45492-098, A45492-099, A46669-025, A46669-028, A46669-035, A46669-037, A46669-043, A46669-044, A47321-011, A47321-012, A47321-013, A47321-014, A47321-015, A47321-016, A47321-017, A47321-018, A47321-019, A47321-020, A47321-021, A47321-022, A47321-023, A47321-024, A47321-025, A47321-026, A47321-027, A47321-028, A47321-029, A47321-030, A47321-031, A47321-032, A47321-033, A47321-034, A47321-035, A47321-036, A47321-037, A47321-038, A47321-039, A47321-040, A47321-041, A47321-042, A47321-043, A47321-044, A48003-011, A48003-012, A48003-013, A48003-014, A48003-015, A48003-016, A48003-017, A48003-018, A48003-019, A48003-020, A48003-021, A48003-022, A48003-023, A48003-024, A48003-025, A48003-026, A48003-027, A48003-028, A48003-029, A48003-030, A48003-031, A48003-032, A48003-033, A48003-034, A48003-035, A48003-036, A48003-037, A48003-039, A48003-040, A48003-041, A48003-042, A48003-043, A48003-044, A48003-045, A48003-046, A48003-047, A48003-048, A48003-049, A48003-050, A48003-051, A48003-052, A48003-053, A48003-054, A48003-055, A48003-056, A48003-057, A48003-058, A48003-059, A48003-060, A48003-061, A48003-062, A48003-063, A48003-064, A48003-065, A48003-066, A48003-067, A48003-068, A48003-069, A48003-070, A48003-071, A48003-072, A48003-073, A48003-074, A48003-075, A48003-076, A48003-077, A48003-078, A48003-079, A48003-080, A48174-012, A48174-015, A48174-016, A48174-017, A48174-018, A48174-019, A48174-020, A48174-021, A48174-022, A48174-023, A48174-024, A48174-025, A48174-026, A48174-027, A48174-028, A48174-029, A48174-030, A48174-031, A48174-032, A48174-033, A48174-034, A48174-035, A48174-036, A48174-037, A48174-038, A48174-039, A48174-041, A48174-042, A48174-043, A48174-044, A48174-045, A48174-046, A48174-047, A48174-051, A48174-054, A48174-057, A48174-058, A48174-059, A48174-060, A48174-061, A48174-062, A48174-063, A48174-064, A48174-065, A48174-066, A48174-067, A48174-068, A48174-069, A48174-070, A48174-071, A48174-072, A48174-073, A48174-074, A48174-075, A48174-076, A48174-077, A48174-078, A48174-079, A48174-080, A48174-081, A48174-082, A48174-083, A48174-084, A48174-085, A48174-086, A48174-087, A48174-088, A48174-089, A48174-090, A48174-092, A48174-093, A48174-094, A48174-095, A48174-096, A48174-097, A48174-098, A48174-099, A48174-100, A48174-101, A48174-102, A48174-103, A48174-104, A48174-105, A48174-106, A48174-107, A48174-108, A48286-016, A48286-017, A48286-018, A48286-019, A48286-020, A48286-021, A48286-022, A48286-023, A48286-024, A48286-025, A48286-026, A48286-027, A48286-028, A48286-029, A48286-030, A48286-031, A48286-032, A48286-033, A48286-034, A48286-035, A48286-036, A48286-037, A48286-038, A48286-039, A48286-040, A48286-041, A48286-042, A48286-043, A48286-044, A48286-045, A48286-046, A48286-047, A48286-048, A48286-049, A48286-050, A48286-051, A48286-052, A48286-053, A48286-054, A48286-055, A48286-056, A48286-057, A48286-058, A48286-059, A48286-060, A48286-061, A48286-062, A48286-063, A48286-064, A48286-065, A48286-066, A48286-067, A48286-068, A48286-069, A48286-070, A48286-071, A48286-072, A48286-073, A48286-074, A48286-075, A48286-076, A48286-077, A48286-078, A48286-079, A48286-080, A48286-081, A48286-082, A48286-083, A48286-084, A48286-085, A48286-086, A48286-087, A48286-088, A48286-089, A48286-090, A48286-092, A48286-093, A48286-094, A48286-095, A48286-096, A48286-097, A48286-098, A48286-099, A48286-100, A48286-101, A48286-102, A48286-103, A48286-104, A48286-105, A48286-106, A48286-107, A48286-108, A48286-109, A48286-110, A48286-111, A48286-112, A48286-113, A48286-114, A48286-115, A48286-116, A48286-117, A48286-118, A48286-119, A48286-120, A48286-121, A48286-122, A48286-123, A48967-011, A48967-012, A48967-013, A48967-014, A48967-015, A48967-016, A48967-017, A48967-018, A48967-019, A48967-020, A48967-021, A48967-022, A48967-023, A48967-024, A48967-025, A48967-026, A48967-027, A48967-028, A48967-029, A48967-030, A48967-031, A48967-032, A48967-033, A48967-034, A48967-035, A48967-036, A48967-037, A48967-038, A48967-039, A48967-040, A48967-042, A48967-043, A48967-044, A48967-045, A48967-046, A48967-047, A48967-048, A48967-049, A48967-050, A48967-051, A48967-052, A48967-053, A48967-054, A48967-055, A48967-056, A48967-057, A48967-058, A48967-059, A48967-060, A48967-062, A48967-063, A48967-064, A48967-065, A48967-066, A48967-067, A48967-068, A48967-069, A48967-070, A48967-071, A48967-072, A48967-073, A48967-074, A48967-075, A48967-076, A48967-077, A48967-078, A48967-079, A48967-080, A48967-081, A48967-082, A48967-083, A48967-084, A48967-085, A48967-086, A48967-087, A48967-088, A48967-089, A48967-090, A49028-081, A49028-082, A49028-083, A49028-084, A49028-085, A49028-086, A49028-087, A49028-088, A49028-089, A49028-090, A49028-091, A49028-092, A49028-093, A49028-094, A49028-095, A49028-096, A49028-097, A49028-098, A49028-102, A49028-103, A49028-104, A49028-105, A49028-106, A49028-107, A49028-108, A49028-109, A49028-110, A49028-111, A49028-112, A49028-113, A49028-114, A49075-011, A49075-013, A49075-014, A49075-015, A49075-016, A49075-017, A49075-018, A49075-019, A49075-020, A49075-021, A49075-022, A49075-023, A49075-026, A49075-027, A49075-030, A49075-031, A49075-032, A49075-033, A49075-034, A49075-035, A49075-036, A49075-037, A49075-039, A49075-040, A49075-041, A49075-042, A49075-043, A49075-044, A49075-045, A49075-046, A49075-047, A49075-048, A...

Label field

Details supplied by the agency

Lot, code or applicability

a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203, GTIN 00763000244705, Serial Numbers: A45206-011, A45206-012, A45206-013, A45206-014, A45206-016, A45206-018, A45206-019, A45206-020, A45206-021, A45206-022, A45206-023, A45206-024, A45206-025, A45206-026, A45206-027, A45206-028, A45206-029, A45206-030, A45206-031, A45206-032, A45206-033, A45206-034, A45206-035, A45206-036, A45206-037, A45206-038, A45206-040, A45206-041, A45206-042, A45206-043, A45206-045, A45206-046, A45206-047, A45206-048, A45206-049, A45206-050, A45206-051, A45206-052, A45206-053, A45206-054, A45206-055, A45206-056, A45206-057, A45206-058, A45206-061, A45206-063, A45206-064, A45206-066, A45206-067, A45206-068, A45206-069, A45206-070, A45206-071, A45206-072, A45489-011, A45489-012, A45489-015, A45489-016, A45489-017, A45489-021, A45489-022, A45489-023, A45489-024, A45489-025, A45489-026, A45489-027, A45489-028, A45489-030, A45489-032, A45489-036, A45489-037, A45489-038, A45489-039, A45489-040, A45489-041, A45489-042, A45489-045, A45489-046, A45489-047, A45489-048, A45489-049, A45489-050, A45489-051, A45870-011, A45870-012, A45870-013, A45870-014, A45870-015, A45870-016, A45870-017, A45870-018, A45870-019, A45870-020, A45870-021, A45870-022, A45870-023, A45870-025, A45870-026, A45870-027, A45870-032, A45870-033, A45870-036, A45870-038, A45870-039, A45870-040, A45870-041, A45870-042, A45870-043, A45870-044, A45870-045, A45870-046, A45870-047, A46716-036, A46716-037, A46716-038, A46716-039, A46716-040, A46716-041, A46716-042, A46716-044, A46716-046, A46716-047, A46716-048, A46716-051, A46716-054, A46716-055, A46716-056, A46716-057, A46716-058, A46716-060, A46716-061, A46716-062, A46716-065, A46716-066, A46716-067, A46716-069, A46716-070, A46716-071, A46716-072, A46716-073, A46716-074, A46716-075, A46716-076, A46716-080, A46716-081, A46716-082, A46716-083, A46716-084, A46716-085, A46716-086, A46716-087, A46716-088, A46716-089, A46716-090, A46716-091, A46716-092, A46716-093, A46716-094, A46716-095, A46716-096, A46716-107, A48729-045, A49241-011, A49241-012, A49241-013, A49241-014, A49241-016, A49241-017, A49241-018, A49241-019, A49241-020, A49241-021, A49241-022, A49241-023, A49241-024, A49241-025, A49241-026, A49241-027, A49241-028, A49241-029, A49241-030, A49241-031, A49241-032, A49241-033, A49241-034, A49241-035, A49241-036, A49241-037, A49241-038, A49241-039, A49241-040, A49241-041, A49241-042, A49241-043, A49241-044, A49241-045, A49241-046, A49241-047, A49241-048, A49241-049, A49241-050, A49241-051, A49241-052, A49241-053, A49241-054, A49241-055, A49241-056, A49241-057, A49241-058, A49241-059, A49241-060, A49241-061, A49241-062, A49241-063, A49241-064, A49241-065, A49241-067, A49241-068, A49241-069, A49241-070, A49241-071, A49241-072, A49241-073, A49241-074, A49241-076, A49241-078, A49241-079, A49241-080, A49241-081, A49241-082, A49241-083, A49241-084, A49241-086, A49241-088, A49241-089, A49241-090, A49241-091, A49241-093, A49241-095, A49241-096, A49241-098, A49241-099, A49241-100, A49241-101, A49241-102, A49241-103, A49241-104, A49241-105, A49555-011, A49555-012, A49555-013, A49555-014, A49555-022, A49555-024, A49555-026, A49555-027, A49555-028, A49555-029, A49555-030, A49555-031, A49555-032, A49555-035, A49818-011, A49818-012, A49818-013, A49818-014, A49818-015, A49818-016, A49818-017, A49818-018, A49818-020, A49818-022, A49818-023, A49818-025, A49818-026, A49818-027, A49818-028, A49818-029, A49818-030, A49818-031, A49818-032, A49818-034, A49818-035, A49818-036, A49818-037, A49818-038, A49818-039, A49818-040, A49818-041, A49818-042, A49818-043, A49818-044, A49818-045, A49818-048, A49818-049, A49818-050, A49818-051, A49818-052, A49818-053, A49818-054, A49818-055, A49818-056, A49818-057, A49818-058, A49818-059, A49818-060, A49818-061, A49818-062, A49818-063, A49818-064, A49818-065, A49818-066, A49818-067, A49818-068, A49818-069, A49818-071, A49818-072, A49818-073, A49818-074, A49818-075, A49818-076, A49818-077, A49818-079, A49818-080, A49818-081, A49818-082, A49818-083, A49818-084, A49818-085, A49818-086, A49818-087, A49818-088, A49818-089, A49818-090, A49818-091, A49818-092, A49818-093, A49818-094, A49818-095, A49818-096, A49818-097, A49818-098, A49818-099, A49818-100, A49818-101, A50197-011, A50197-014, A50197-015, A50197-017, A50197-018, A50197-019, A50197-020, A50197-021, A50197-022, A50197-024, A50197-025, A50197-026, A50197-027, A50197-028, A50197-029, A50197-030, A50197-031, A50197-032, A50197-033, A50197-034, A50197-035, A50197-036, A50197-037, A50197-038, A50197-039, A50197-040, A50197-041, A50197-042, A50197-043, A50197-047, A50197-048, A50197-049, A50197-050, A50197-051, A50197-052, A50197-053, A50197-054, A50197-055, A50197-056, A50197-057, A50197-058, A50197-059, A50197-060, A50197-061, A50197-062, A50197-063, A50197-064, A50197-065, A50197-066, A50197-067, A50197-068, A50197-069, A50197-070, A50197-071, A50197-072, A50197-073, A50197-074, A50197-075, A50197-076, A50197-077, A50197-078, A50197-079; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206, GTIN 00763000244712, Serial Numbers: A42287-087, A42287-088, A42287-089, A42287-090, A42287-092, A42287-093, A42287-094, A42287-095, A42287-100, A42287-101, A42287-102, A42287-103, A42287-104, A42287-105, A42287-108, A42287-112, A42287-113, A42287-114, A42287-116, A42287-117, A42287-118, A42287-119, A42287-121, A42287-122, A42287-123, A42287-124, A42287-125, A42287-126, A42287-160, A42287-161, A42287-162, A42287-163, A42287-164, A42287-165, A42287-166, A42287-167, A45179-026, A45179-027, A45179-028, A45179-029, A45179-030, A45179-031, A45179-032, A45179-033, A45179-034, A45179-036, A45179-037, A45179-038, A45179-039, A45179-040, A45179-041, A45179-042, A45179-043, A45179-044, A45179-045, A45179-046, A45179-047, A45179-048, A45179-051, A45179-052, A45179-054, A45179-055, A45179-056, A45179-057, A45179-058, A45179-059, A45179-060, A45179-061, A45179-062, A45179-063, A45179-064, A45492-013, A45492-014, A45492-015, A45492-016, A45492-017, A45492-019, A45492-020, A45492-023, A45492-024, A45492-025, A45492-026, A45492-027, A45492-028, A45492-029, A45492-031, A45492-032, A45492-033, A45492-038, A45492-039, A45492-040, A45492-041, A45492-042, A45492-043, A45492-045, A45492-046, A45492-047, A45492-048, A45492-049, A45492-050, A45492-051, A45492-052, A45492-053, A45492-054, A45492-057, A45492-058, A45492-060, A45492-062, A45492-063, A45492-064, A45492-065, A45492-066, A45492-068, A45492-070, A45492-071, A45492-072, A45492-073, A45492-074, A45492-075, A45492-076, A45492-077, A45492-078, A45492-079, A45492-080, A45492-081, A45492-084, A45492-085, A45492-086, A45492-091, A45492-092, A45492-096, A45492-097, A45492-098, A45492-099, A46669-025, A46669-028, A46669-035, A46669-037, A46669-043, A46669-044, A47321-011, A47321-012, A47321-013, A47321-014, A47321-015, A47321-016, A47321-017, A47321-018, A47321-019, A47321-020, A47321-021, A47321-022, A47321-023, A47321-024, A47321-025, A47321-026, A47321-027, A47321-028, A47321-029, A47321-030, A47321-031, A47321-032, A47321-033, A47321-034, A47321-035, A47321-036, A47321-037, A47321-038, A47321-039, A47321-040, A47321-041, A47321-042, A47321-043, A47321-044, A48003-011, A48003-012, A48003-013, A48003-014, A48003-015, A48003-016, A48003-017, A48003-018, A48003-019, A48003-020, A48003-021, A48003-022, A48003-023, A48003-024, A48003-025, A48003-026, A48003-027, A48003-028, A48003-029, A48003-030, A48003-031, A48003-032, A48003-033, A48003-034, A48003-035, A48003-036, A48003-037, A48003-039, A48003-040, A48003-041, A48003-042, A48003-043, A48003-044, A48003-045, A48003-046, A48003-047, A48003-048, A48003-049, A48003-050, A48003-051, A48003-052, A48003-053, A48003-054, A48003-055, A48003-056, A48003-057, A48003-058, A48003-059, A48003-060, A48003-061, A48003-062, A48003-063, A48003-064, A48003-065, A48003-066, A48003-067, A48003-068, A48003-069, A48003-070, A48003-071, A48003-072, A48003-073, A48003-074, A48003-075, A48003-076, A48003-077, A48003-078, A48003-079, A48003-080, A48174-012, A48174-015, A48174-016, A48174-017, A48174-018, A48174-019, A48174-020, A48174-021, A48174-022, A48174-023, A48174-024, A48174-025, A48174-026, A48174-027, A48174-028, A48174-029, A48174-030, A48174-031, A48174-032, A48174-033, A48174-034, A48174-035, A48174-036, A48174-037, A48174-038, A48174-039, A48174-041, A48174-042, A48174-043, A48174-044, A48174-045, A48174-046, A48174-047, A48174-051, A48174-054, A48174-057, A48174-058, A48174-059, A48174-060, A48174-061, A48174-062, A48174-063, A48174-064, A48174-065, A48174-066, A48174-067, A48174-068, A48174-069, A48174-070, A48174-071, A48174-072, A48174-073, A48174-074, A48174-075, A48174-076, A48174-077, A48174-078, A48174-079, A48174-080, A48174-081, A48174-082, A48174-083, A48174-084, A48174-085, A48174-086, A48174-087, A48174-088, A48174-089, A48174-090, A48174-092, A48174-093, A48174-094, A48174-095, A48174-096, A48174-097, A48174-098, A48174-099, A48174-100, A48174-101, A48174-102, A48174-103, A48174-104, A48174-105, A48174-106, A48174-107, A48174-108, A48286-016, A48286-017, A48286-018, A48286-019, A48286-020, A48286-021, A48286-022, A48286-023, A48286-024, A48286-025, A48286-026, A48286-027, A48286-028, A48286-029, A48286-030, A48286-031, A48286-032, A48286-033, A48286-034, A48286-035, A48286-036, A48286-037, A48286-038, A48286-039, A48286-040, A48286-041, A48286-042, A48286-043, A48286-044, A48286-045, A48286-046, A48286-047, A48286-048, A48286-049, A48286-050, A48286-051, A48286-052, A48286-053, A48286-054, A48286-055, A48286-056, A48286-057, A48286-058, A48286-059, A48286-060, A48286-061, A48286-062, A48286-063, A48286-064, A48286-065, A48286-066, A48286-067, A48286-068, A48286-069, A48286-070, A48286-071, A48286-072, A48286-073, A48286-074, A48286-075, A48286-076, A48286-077, A48286-078, A48286-079, A48286-080, A48286-081, A48286-082, A48286-083, A48286-084, A48286-085, A48286-086, A48286-087, A48286-088, A48286-089, A48286-090, A48286-092, A48286-093, A48286-094, A48286-095, A48286-096, A48286-097, A48286-098, A48286-099, A48286-100, A48286-101, A48286-102, A48286-103, A48286-104, A48286-105, A48286-106, A48286-107, A48286-108, A48286-109, A48286-110, A48286-111, A48286-112, A48286-113, A48286-114, A48286-115, A48286-116, A48286-117, A48286-118, A48286-119, A48286-120, A48286-121, A48286-122, A48286-123, A48967-011, A48967-012, A48967-013, A48967-014, A48967-015, A48967-016, A48967-017, A48967-018, A48967-019, A48967-020, A48967-021, A48967-022, A48967-023, A48967-024, A48967-025, A48967-026, A48967-027, A48967-028, A48967-029, A48967-030, A48967-031, A48967-032, A48967-033, A48967-034, A48967-035, A48967-036, A48967-037, A48967-038, A48967-039, A48967-040, A48967-042, A48967-043, A48967-044, A48967-045, A48967-046, A48967-047, A48967-048, A48967-049, A48967-050, A48967-051, A48967-052, A48967-053, A48967-054, A48967-055, A48967-056, A48967-057, A48967-058, A48967-059, A48967-060, A48967-062, A48967-063, A48967-064, A48967-065, A48967-066, A48967-067, A48967-068, A48967-069, A48967-070, A48967-071, A48967-072, A48967-073, A48967-074, A48967-075, A48967-076, A48967-077, A48967-078, A48967-079, A48967-080, A48967-081, A48967-082, A48967-083, A48967-084, A48967-085, A48967-086, A48967-087, A48967-088, A48967-089, A48967-090, A49028-081, A49028-082, A49028-083, A49028-084, A49028-085, A49028-086, A49028-087, A49028-088, A49028-089, A49028-090, A49028-091, A49028-092, A49028-093, A49028-094, A49028-095, A49028-096, A49028-097, A49028-098, A49028-102, A49028-103, A49028-104, A49028-105, A49028-106, A49028-107, A49028-108, A49028-109, A49028-110, A49028-111, A49028-112, A49028-113, A49028-114, A49075-011, A49075-013, A49075-014, A49075-015, A49075-016, A49075-017, A49075-018, A49075-019, A49075-020, A49075-021, A49075-022, A49075-023, A49075-026, A49075-027, A49075-030, A49075-031, A49075-032, A49075-033, A49075-034, A49075-035, A49075-036, A49075-037, A49075-039, A49075-040, A49075-041, A49075-042, A49075-043, A49075-044, A49075-045, A49075-046, A49075-047, A49075-048, A...

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