Recall archive / FDA device enforcement

Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50... — FDA record Z-1331-2023

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 DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; 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: 10037 units
Agency-reported status: Ongoing
Source record identifier: Z-1331-2023

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) GRAFTON T50303 DBF INJECT 3CC, REF T50303, GTIN 00763000254001, Serial Numbers: A44493-011, A44493-012, A44493-013, A44493-014, A44493-015, A44493-016, A44493-017, A44493-018, A44493-019, A44493-020, A44493-021, A44493-022, A44493-023, A44493-025, A44493-028, A44591-011, A44591-012, A44591-013, A44591-014, A44591-015, A44591-016, A44591-017, A44591-018, A44591-019, A44591-020, A44591-021, A44591-022, A44591-023, A44591-024, A44591-025, A44591-026, A44591-027, A44591-028, A44591-029, A44591-030, A44591-031, A44591-032, A44591-033, A44591-034, A44591-035, A44591-036, A44591-037, A44591-039, A44591-041, A44591-042, A44591-043, A44591-044, A44591-045, A44591-046, A44591-047, A44591-048, A44591-049, A44591-050, A44591-051, A44591-052, A44591-053, A44591-054, A44591-055, A44591-056, A44591-057, A44591-058, A44591-059, A44591-060, A44591-061, A44591-062, A44591-064, A44591-065, A44591-066, A44591-067, A44591-068, A44591-069, A44591-070, A44591-071, A44591-072, A44591-073, A44591-074, A46056-011, A46056-014, A46056-017, A46056-018, A46056-019, A46056-020, A46056-021, A46056-022, A46056-023, A46056-024, A46056-025, A46056-026, A46056-028, A46056-029, A46056-030, A46056-031, A46056-032, A46056-033, A46056-034, A46056-035, A46056-036, A46056-037, A46056-038, A46056-039, A46056-040, A46056-041, A46056-042, A46056-043, A46056-044, A46056-045, A46056-046, A46056-047, A46056-048, A46056-049, A46056-050, A46345-021, A46345-022, A46345-023, A46345-024, A46345-025, A46345-026, A46345-027, A46345-028, A46345-029, A46345-030, A46345-031, A46345-032, A46345-033, A46345-034, A46345-035, A46345-036, A46345-037, A46345-038, A47835-011, A47835-012, A47835-013, A47835-014, A47835-015, A47835-016, A47835-017, A47835-018, A47835-019, A47835-020, A47835-021, A47835-022, A47835-023, A47835-024, A47835-025, A47835-026, A47835-027, A47835-028, A47835-029, A47835-030, A47835-031, A47835-032, A47835-033, A47835-034, A47835-036, A47835-037, A47835-038, A49756-012, A49756-013, A49756-014, A49756-015, A49756-016, A49756-017, A49756-018, A49756-019, A49756-020, A49756-021, A49756-022, A49756-023, A49756-024, A49756-025, A49756-026, A49756-027, A49756-030, A49756-031, A49756-032, A49756-033, A49756-034, A49756-035, A49756-036, A49756-037, A49756-038, A49756-039, A49756-040, A49756-041, A49756-042, A49756-044, A49756-045, A49756-046, A49756-047, A49756-050, A49756-052, A49756-053, A49756-054, A49756-055, A49756-056, A49756-057, A49756-058, A49756-059, A49756-060, A49756-061, A49756-062, A49756-063, A49756-064, A49802-051, A49802-052, A49802-053, A49802-054, A49802-055, A49802-056, A49802-057, A49802-058, A49802-059, A49802-060, A49802-061, A49802-062, A49802-063, A49802-064, A49802-065, A49802-066, A49802-067, A49802-068, A49802-069, A49802-070, A49802-071, A49802-072, A49802-073, A49802-074, A49802-075, A49802-076, A49802-077, A50048-011, A50048-012, A50048-013, A50048-014, A50048-015, A50048-016, A50048-017, A50048-018, A50048-019, A50048-020, A50048-021, A50048-022, A50048-024, A50048-025, A50048-026, A50048-027, A50048-028, A50048-029, A50048-030, A50048-031, A50048-032, A50048-034, A50048-035, A50048-036, A50048-037, A50048-038, A50048-039, A50048-040, A50048-041, A50048-042, A50048-043, A50048-044, A50673-011, A50673-012, A50673-013, A50673-014, A50673-015, A50673-016, A50673-017, A50673-018, A50673-019, A50673-020, A50673-021, A50673-022, A50673-023, A50673-025, A50673-026, A50673-027, A50673-028, A50673-029, A50673-030, A50673-031, A50673-032, A50673-033, A50673-034, A50673-035, A50673-036, A50673-037, A50673-038, A50673-039, A50673-040, A50673-041, A50673-042, A50673-043, A50673-044, A50673-045, A50673-046, A50673-047, A50673-048, A50673-049, A50673-050, A50673-051, A50673-052, A50673-053, A50673-054, A50673-055, A50695-011, A50695-012, A50695-013, A50695-014, A50695-015, A50695-019, A50695-020, A50695-021, A50695-022, A50695-023, A50695-024, A50695-025, A50695-026, A50695-027, A50695-028, A50695-029, A50695-031, A50695-032, A50695-033, A50695-034, A50695-035, A50695-036, A50695-037, A50695-038, A50695-039, A50695-040, A50695-041, A50695-042, A50695-043, A50695-044, A50695-045, A50695-046, A50695-047, A50695-048, A50695-049, A50695-050, A50695-051, A50695-052, A50695-053, A50695-054, A50695-055, A50695-056, A50695-057, A50695-058, A50695-059, A50695-060, A50695-061, A50695-062, A50695-063, A50695-065, A50695-066, A50695-067, A50695-068, A50695-069, A50695-070, A50695-072, A50695-073, A50695-074, A50695-075, A50695-076, A50695-077, A50695-078, A50695-079, A50695-080, A50695-081, A50695-082, A50695-083, A50695-084, A50695-085, A50695-086, A50695-087, A50695-088, A50695-089, A50695-090, A50695-091, A50695-092, A50695-093, A50695-094, A50695-095, A50695-096, A50695-097, A50695-098, A50695-099, A50695-100, A50695-101, A50695-102, A50695-103, A50695-104, A50695-105, A50695-106, A50807-011, A50807-012, A50807-013, A50807-014, A50807-015, A50807-016, A50807-017, A50807-018, A50807-019, A50807-020, A50807-021, A50807-022, A50807-023, A50807-024, A50807-025, A50807-029, A50807-030, A50807-031, A50807-032, A50807-033, A50807-034, A50807-036, A50807-037, A50807-038, A50807-039, A50807-040, A50807-041, A50807-042, A50807-043, A50807-044, A50807-045, A50807-046, A50807-047, A50807-048, A50807-049, A50807-050, A50807-051, A50807-052, A50807-053, A50807-054, A50807-055, A50807-056, A50807-057, A50807-058, A50807-059, A50807-060, A50807-061, A50807-062, A50807-063, A50807-064, A50807-065, A50807-066, A50807-067, A50807-068, A50807-069, A50807-070, A50807-071, A50807-072, A50807-073, A50807-074, A50807-075, A50807-076, A50807-077, A50807-078, A50807-079, A50807-081, A50807-082, A50807-083, A50807-084, A50807-085, A50807-086, A50807-087, A50807-088, A50807-090, A50807-091, A50807-092, A50807-093, A50807-094, A50807-095, A50807-096, A50807-097, A50884-011, A50884-012, A50884-013, A50884-014, A50884-015, A50884-016, A50884-017, A50884-018, A50884-019, A50884-020, A50884-021, A50884-022, A50884-023, A50884-024, A50884-025, A50884-026, A50884-027, A50884-029, A51302-011, A51302-012, A51302-013, A51302-014, A51302-015, A51302-016, A51302-017, A51302-018, A51302-019, A51302-020, A51302-021, A51302-022, A51302-023, A51302-024, A51302-025, A51302-026, A51302-027, A51302-028, A51302-029, A51302-030, A51302-031, A51302-032, A51302-033, A51302-034, A51302-035, A51302-036, A51302-037, A51302-038, A51302-039, A51302-040, A51302-041, A51302-042, A51302-043, A51302-044, A51302-045, A51302-046, A51302-047, A51302-048, A51302-049, A51302-050, A51302-051, A51302-052, A51302-053, A51302-054, A51302-055, A51302-056, A51302-058, A51302-059, A51302-060, A51302-061, A51302-062, A51302-063, A51302-064, A51302-065, A51302-067, A51302-068, A51302-069, A51302-070, A51302-071, A51302-072, A51302-073, A51302-074, A51459-011, A51459-012, A51459-013, A51459-014, A51459-015, A51459-016, A51459-017, A51459-018, A51459-019, A51459-020, A51459-021, A51459-022, A51459-024, A51459-025, A51459-026, A51459-027, A51459-028, A51459-029, A51459-030, A51459-032, A51459-034, A51459-035, A51459-036, A51459-037, A51459-038, A51459-039, A51459-040, A51459-041, A51459-042, A51459-043, A51459-044, A51459-045, A51459-046, A51459-047, A51459-048, A51459-049, A51459-050, A51459-051, A51459-052, A51459-053, A51459-054, A51459-055, A51459-056, A51459-057, A51459-058, A51459-059, A51459-060, A51459-061, A51459-062, A51459-063, A51459-064, A51459-065, A51459-066, A51459-067, A51459-068, A51459-069, A51459-070, A51459-071, A51776-021, A51776-022, A51776-023, A51776-024, A51776-025, A51776-026, A51776-027, A51776-028, A51776-029, A51776-030, A51776-031, A51776-032, A51776-033, A51776-034, A51776-035, A51776-036, A51776-037, A51776-038, A51776-039, A51776-040, A51776-041, A51776-042, A51776-043, A51776-044, A51776-045, A51776-046, A51776-047, A51776-048, A51776-049, A51776-050, A51776-051, A51776-052, A51776-053, A51776-054, A51776-055, A51776-056, A51776-057, A51776-058, A51776-059, A51776-060, A51776-061, A51776-062, A51776-063, A51776-064, A51776-065, A51794-011, A51794-012, A51794-013, A51794-014, A51794-015, A51794-016, A51794-017, A51794-018, A51794-019, A51794-020, A51794-021, A51794-022, A51794-023, A51794-024, A51794-025, A51794-026, A51794-027, A51794-028, A51794-029, A51794-030, A51794-031, A51794-032, A51794-033, A51794-034, A51794-035, A51794-036, A51794-037, A51794-038, A51794-040, A51794-041, A51794-042, A51794-043, A51794-044, A51794-045, A51794-046, A51794-047, A51794-048, A51794-050, A51794-051, A51794-052, A51794-053, A51794-054, A51794-055, A51794-056, A51794-057, A51794-058, A51794-059, A51794-060, A51794-061, A51794-062, A51794-063, A51794-064, A51794-065, A51794-066, A51794-067, A51794-068, A51794-069, A51794-070, A51794-071, A51794-072, A51794-073, A51794-074, A51794-075, A51865-011, A51865-012, A51865-013, A51865-014, A51865-015, A51865-016, A51865-017, A51865-018, A51865-019, A51865-020, A51865-021, A51865-022, A51865-023, A51865-024, A51865-025, A51865-026, A51865-029, A51865-030, A51865-031, A51865-032, A51865-033, A51865-034, A51865-035, A51865-036, A51865-037, A51865-038, A51865-039, A51865-040, A51865-041, A51865-042, A51865-043, A51865-044, A51865-045, A51865-046, A51865-047, A51865-048, A51865-049, A51865-050, A51876-011, A51876-012, A51876-013, A51876-014, A51876-015, A51876-016, A51876-017, A51876-018, A51876-019, A51876-020, A51876-021, A51876-022, A51876-023, A51876-024, A51876-025, A51876-026, A51876-027, A51876-029, A51876-031, A51876-032, A51876-033, A51876-034, A51876-035, A51876-036, A51876-038, A51876-039, A51876-040, A51876-041, A51876-042, A51889-011, A51889-012, A51889-013, A51889-014, A51889-015, A51889-016, A51889-019, A51889-020, A51889-021, A51889-022, A51889-023, A51889-024, A51889-025, A51889-026, A51889-027, A51889-029, A51889-030, A51889-031, A51889-032, A51889-034, A51889-035, A51889-036, A51889-037, A51889-038, A51889-039, A51889-040, A51889-041, A51889-042, A51889-043, A51889-044, A51889-045, A51889-046, A51889-047, A51889-048, A51889-049, A51889-050, A51895-011, A51895-012, A51895-013, A51895-014, A51895-015, A51895-016, A51895-017, A51895-018, A51895-019, A51895-020, A51895-021, A51895-022, A51895-023, A51895-024, A51895-025, A51895-026, A51895-027, A51895-028, A51895-029, A51895-030, A51895-031, A51895-033, A51895-034, A51895-035, A51895-036, A51895-037, A51895-038, A51895-039, A51895-040, A51895-041, A51895-042, A51895-043, A51895-044, A51895-045, A51895-046, A51895-047, A51895-048, A52040-011, A52040-012, A52040-013, A52040-014, A52040-015, A52040-016, A52040-017, A52040-018, A52040-019, A52040-020, A52040-021, A52040-022, A52040-023, A52040-026, A52040-027, A52040-028, A52040-029, A52040-030, A52040-031, A52040-032, A52040-033, A52040-034, A52040-035, A52040-036, A52040-037, A52040-038, A52040-039, A52040-040, A52040-041, A52040-042, A52040-044, A52040-045, A52040-046, A52040-047, A52040-048, A52040-049, A52040-051, A52040-052, A52040-053, A52040-054, A52040-055, A52040-056, A52040-057, A52040-058, A52040-059, A52040-060, A52040-061, A52040-063, A52040-064, A52040-065, A52040-066, A52040-067, A52040-068, A52040-069, A52306-011, A52306-012, A52306-013, A52306-014, A52306-015, A52306-016, A52306-017, A52306-018, A52306-019, A52306-020, A52306-021, A52306-022, A52306-023, A52306-024, A52306-025, A52306-026, A52306-027, A52306-028, A52306-029, A52306-030, A52306-031, A52306-034, A52306-035, A52306-036, A52306-037, A52306-038, A52306-039, A52306-040, A52306-041, A52306-042, A52306-043, A52306-044, A52306-045, A52306-046, A52306-047, A52306-048, A52306-049, A52306-050, A52345-051, A52345-052, A52345-053, A52345-054, A52345-055, A52345-056, A52345-057, A52345-058, A52345-059, A52345-060, A52345-061, A52345-062, A52345-063, A52345-064, A52345-065, A52345-066, A52345-067, A52345-068, A52345-069, A52345-070, A52347-011, A52347-012, A52347-013, A52347-014, A52347-015, A52347-016, A52347-017, A52347-018, A52347-019, A52347-020, A52347-021, A52347-022, A52347-023, A52347-024, A52347-025, A52347-026, A52347-027, A52347-028...

Label field

Details supplied by the agency

Lot, code or applicability

a) GRAFTON T50303 DBF INJECT 3CC, REF T50303, GTIN 00763000254001, Serial Numbers: A44493-011, A44493-012, A44493-013, A44493-014, A44493-015, A44493-016, A44493-017, A44493-018, A44493-019, A44493-020, A44493-021, A44493-022, A44493-023, A44493-025, A44493-028, A44591-011, A44591-012, A44591-013, A44591-014, A44591-015, A44591-016, A44591-017, A44591-018, A44591-019, A44591-020, A44591-021, A44591-022, A44591-023, A44591-024, A44591-025, A44591-026, A44591-027, A44591-028, A44591-029, A44591-030, A44591-031, A44591-032, A44591-033, A44591-034, A44591-035, A44591-036, A44591-037, A44591-039, A44591-041, A44591-042, A44591-043, A44591-044, A44591-045, A44591-046, A44591-047, A44591-048, A44591-049, A44591-050, A44591-051, A44591-052, A44591-053, A44591-054, A44591-055, A44591-056, A44591-057, A44591-058, A44591-059, A44591-060, A44591-061, A44591-062, A44591-064, A44591-065, A44591-066, A44591-067, A44591-068, A44591-069, A44591-070, A44591-071, A44591-072, A44591-073, A44591-074, A46056-011, A46056-014, A46056-017, A46056-018, A46056-019, A46056-020, A46056-021, A46056-022, A46056-023, A46056-024, A46056-025, A46056-026, A46056-028, A46056-029, A46056-030, A46056-031, A46056-032, A46056-033, A46056-034, A46056-035, A46056-036, A46056-037, A46056-038, A46056-039, A46056-040, A46056-041, A46056-042, A46056-043, A46056-044, A46056-045, A46056-046, A46056-047, A46056-048, A46056-049, A46056-050, A46345-021, A46345-022, A46345-023, A46345-024, A46345-025, A46345-026, A46345-027, A46345-028, A46345-029, A46345-030, A46345-031, A46345-032, A46345-033, A46345-034, A46345-035, A46345-036, A46345-037, A46345-038, A47835-011, A47835-012, A47835-013, A47835-014, A47835-015, A47835-016, A47835-017, A47835-018, A47835-019, A47835-020, A47835-021, A47835-022, A47835-023, A47835-024, A47835-025, A47835-026, A47835-027, A47835-028, A47835-029, A47835-030, A47835-031, A47835-032, A47835-033, A47835-034, A47835-036, A47835-037, A47835-038, A49756-012, A49756-013, A49756-014, A49756-015, A49756-016, A49756-017, A49756-018, A49756-019, A49756-020, A49756-021, A49756-022, A49756-023, A49756-024, A49756-025, A49756-026, A49756-027, A49756-030, A49756-031, A49756-032, A49756-033, A49756-034, A49756-035, A49756-036, A49756-037, A49756-038, A49756-039, A49756-040, A49756-041, A49756-042, A49756-044, A49756-045, A49756-046, A49756-047, A49756-050, A49756-052, A49756-053, A49756-054, A49756-055, A49756-056, A49756-057, A49756-058, A49756-059, A49756-060, A49756-061, A49756-062, A49756-063, A49756-064, A49802-051, A49802-052, A49802-053, A49802-054, A49802-055, A49802-056, A49802-057, A49802-058, A49802-059, A49802-060, A49802-061, A49802-062, A49802-063, A49802-064, A49802-065, A49802-066, A49802-067, A49802-068, A49802-069, A49802-070, A49802-071, A49802-072, A49802-073, A49802-074, A49802-075, A49802-076, A49802-077, A50048-011, A50048-012, A50048-013, A50048-014, A50048-015, A50048-016, A50048-017, A50048-018, A50048-019, A50048-020, A50048-021, A50048-022, A50048-024, A50048-025, A50048-026, A50048-027, A50048-028, A50048-029, A50048-030, A50048-031, A50048-032, A50048-034, A50048-035, A50048-036, A50048-037, A50048-038, A50048-039, A50048-040, A50048-041, A50048-042, A50048-043, A50048-044, A50673-011, A50673-012, A50673-013, A50673-014, A50673-015, A50673-016, A50673-017, A50673-018, A50673-019, A50673-020, A50673-021, A50673-022, A50673-023, A50673-025, A50673-026, A50673-027, A50673-028, A50673-029, A50673-030, A50673-031, A50673-032, A50673-033, A50673-034, A50673-035, A50673-036, A50673-037, A50673-038, A50673-039, A50673-040, A50673-041, A50673-042, A50673-043, A50673-044, A50673-045, A50673-046, A50673-047, A50673-048, A50673-049, A50673-050, A50673-051, A50673-052, A50673-053, A50673-054, A50673-055, A50695-011, A50695-012, A50695-013, A50695-014, A50695-015, A50695-019, A50695-020, A50695-021, A50695-022, A50695-023, A50695-024, A50695-025, A50695-026, A50695-027, A50695-028, A50695-029, A50695-031, A50695-032, A50695-033, A50695-034, A50695-035, A50695-036, A50695-037, A50695-038, A50695-039, A50695-040, A50695-041, A50695-042, A50695-043, A50695-044, A50695-045, A50695-046, A50695-047, A50695-048, A50695-049, A50695-050, A50695-051, A50695-052, A50695-053, A50695-054, A50695-055, A50695-056, A50695-057, A50695-058, A50695-059, A50695-060, A50695-061, A50695-062, A50695-063, A50695-065, A50695-066, A50695-067, A50695-068, A50695-069, A50695-070, A50695-072, A50695-073, A50695-074, A50695-075, A50695-076, A50695-077, A50695-078, A50695-079, A50695-080, A50695-081, A50695-082, A50695-083, A50695-084, A50695-085, A50695-086, A50695-087, A50695-088, A50695-089, A50695-090, A50695-091, A50695-092, A50695-093, A50695-094, A50695-095, A50695-096, A50695-097, A50695-098, A50695-099, A50695-100, A50695-101, A50695-102, A50695-103, A50695-104, A50695-105, A50695-106, A50807-011, A50807-012, A50807-013, A50807-014, A50807-015, A50807-016, A50807-017, A50807-018, A50807-019, A50807-020, A50807-021, A50807-022, A50807-023, A50807-024, A50807-025, A50807-029, A50807-030, A50807-031, A50807-032, A50807-033, A50807-034, A50807-036, A50807-037, A50807-038, A50807-039, A50807-040, A50807-041, A50807-042, A50807-043, A50807-044, A50807-045, A50807-046, A50807-047, A50807-048, A50807-049, A50807-050, A50807-051, A50807-052, A50807-053, A50807-054, A50807-055, A50807-056, A50807-057, A50807-058, A50807-059, A50807-060, A50807-061, A50807-062, A50807-063, A50807-064, A50807-065, A50807-066, A50807-067, A50807-068, A50807-069, A50807-070, A50807-071, A50807-072, A50807-073, A50807-074, A50807-075, A50807-076, A50807-077, A50807-078, A50807-079, A50807-081, A50807-082, A50807-083, A50807-084, A50807-085, A50807-086, A50807-087, A50807-088, A50807-090, A50807-091, A50807-092, A50807-093, A50807-094, A50807-095, A50807-096, A50807-097, A50884-011, A50884-012, A50884-013, A50884-014, A50884-015, A50884-016, A50884-017, A50884-018, A50884-019, A50884-020, A50884-021, A50884-022, A50884-023, A50884-024, A50884-025, A50884-026, A50884-027, A50884-029, A51302-011, A51302-012, A51302-013, A51302-014, A51302-015, A51302-016, A51302-017, A51302-018, A51302-019, A51302-020, A51302-021, A51302-022, A51302-023, A51302-024, A51302-025, A51302-026, A51302-027, A51302-028, A51302-029, A51302-030, A51302-031, A51302-032, A51302-033, A51302-034, A51302-035, A51302-036, A51302-037, A51302-038, A51302-039, A51302-040, A51302-041, A51302-042, A51302-043, A51302-044, A51302-045, A51302-046, A51302-047, A51302-048, A51302-049, A51302-050, A51302-051, A51302-052, A51302-053, A51302-054, A51302-055, A51302-056, A51302-058, A51302-059, A51302-060, A51302-061, A51302-062, A51302-063, A51302-064, A51302-065, A51302-067, A51302-068, A51302-069, A51302-070, A51302-071, A51302-072, A51302-073, A51302-074, A51459-011, A51459-012, A51459-013, A51459-014, A51459-015, A51459-016, A51459-017, A51459-018, A51459-019, A51459-020, A51459-021, A51459-022, A51459-024, A51459-025, A51459-026, A51459-027, A51459-028, A51459-029, A51459-030, A51459-032, A51459-034, A51459-035, A51459-036, A51459-037, A51459-038, A51459-039, A51459-040, A51459-041, A51459-042, A51459-043, A51459-044, A51459-045, A51459-046, A51459-047, A51459-048, A51459-049, A51459-050, A51459-051, A51459-052, A51459-053, A51459-054, A51459-055, A51459-056, A51459-057, A51459-058, A51459-059, A51459-060, A51459-061, A51459-062, A51459-063, A51459-064, A51459-065, A51459-066, A51459-067, A51459-068, A51459-069, A51459-070, A51459-071, A51776-021, A51776-022, A51776-023, A51776-024, A51776-025, A51776-026, A51776-027, A51776-028, A51776-029, A51776-030, A51776-031, A51776-032, A51776-033, A51776-034, A51776-035, A51776-036, A51776-037, A51776-038, A51776-039, A51776-040, A51776-041, A51776-042, A51776-043, A51776-044, A51776-045, A51776-046, A51776-047, A51776-048, A51776-049, A51776-050, A51776-051, A51776-052, A51776-053, A51776-054, A51776-055, A51776-056, A51776-057, A51776-058, A51776-059, A51776-060, A51776-061, A51776-062, A51776-063, A51776-064, A51776-065, A51794-011, A51794-012, A51794-013, A51794-014, A51794-015, A51794-016, A51794-017, A51794-018, A51794-019, A51794-020, A51794-021, A51794-022, A51794-023, A51794-024, A51794-025, A51794-026, A51794-027, A51794-028, A51794-029, A51794-030, A51794-031, A51794-032, A51794-033, A51794-034, A51794-035, A51794-036, A51794-037, A51794-038, A51794-040, A51794-041, A51794-042, A51794-043, A51794-044, A51794-045, A51794-046, A51794-047, A51794-048, A51794-050, A51794-051, A51794-052, A51794-053, A51794-054, A51794-055, A51794-056, A51794-057, A51794-058, A51794-059, A51794-060, A51794-061, A51794-062, A51794-063, A51794-064, A51794-065, A51794-066, A51794-067, A51794-068, A51794-069, A51794-070, A51794-071, A51794-072, A51794-073, A51794-074, A51794-075, A51865-011, A51865-012, A51865-013, A51865-014, A51865-015, A51865-016, A51865-017, A51865-018, A51865-019, A51865-020, A51865-021, A51865-022, A51865-023, A51865-024, A51865-025, A51865-026, A51865-029, A51865-030, A51865-031, A51865-032, A51865-033, A51865-034, A51865-035, A51865-036, A51865-037, A51865-038, A51865-039, A51865-040, A51865-041, A51865-042, A51865-043, A51865-044, A51865-045, A51865-046, A51865-047, A51865-048, A51865-049, A51865-050, A51876-011, A51876-012, A51876-013, A51876-014, A51876-015, A51876-016, A51876-017, A51876-018, A51876-019, A51876-020, A51876-021, A51876-022, A51876-023, A51876-024, A51876-025, A51876-026, A51876-027, A51876-029, A51876-031, A51876-032, A51876-033, A51876-034, A51876-035, A51876-036, A51876-038, A51876-039, A51876-040, A51876-041, A51876-042, A51889-011, A51889-012, A51889-013, A51889-014, A51889-015, A51889-016, A51889-019, A51889-020, A51889-021, A51889-022, A51889-023, A51889-024, A51889-025, A51889-026, A51889-027, A51889-029, A51889-030, A51889-031, A51889-032, A51889-034, A51889-035, A51889-036, A51889-037, A51889-038, A51889-039, A51889-040, A51889-041, A51889-042, A51889-043, A51889-044, A51889-045, A51889-046, A51889-047, A51889-048, A51889-049, A51889-050, A51895-011, A51895-012, A51895-013, A51895-014, A51895-015, A51895-016, A51895-017, A51895-018, A51895-019, A51895-020, A51895-021, A51895-022, A51895-023, A51895-024, A51895-025, A51895-026, A51895-027, A51895-028, A51895-029, A51895-030, A51895-031, A51895-033, A51895-034, A51895-035, A51895-036, A51895-037, A51895-038, A51895-039, A51895-040, A51895-041, A51895-042, A51895-043, A51895-044, A51895-045, A51895-046, A51895-047, A51895-048, A52040-011, A52040-012, A52040-013, A52040-014, A52040-015, A52040-016, A52040-017, A52040-018, A52040-019, A52040-020, A52040-021, A52040-022, A52040-023, A52040-026, A52040-027, A52040-028, A52040-029, A52040-030, A52040-031, A52040-032, A52040-033, A52040-034, A52040-035, A52040-036, A52040-037, A52040-038, A52040-039, A52040-040, A52040-041, A52040-042, A52040-044, A52040-045, A52040-046, A52040-047, A52040-048, A52040-049, A52040-051, A52040-052, A52040-053, A52040-054, A52040-055, A52040-056, A52040-057, A52040-058, A52040-059, A52040-060, A52040-061, A52040-063, A52040-064, A52040-065, A52040-066, A52040-067, A52040-068, A52040-069, A52306-011, A52306-012, A52306-013, A52306-014, A52306-015, A52306-016, A52306-017, A52306-018, A52306-019, A52306-020, A52306-021, A52306-022, A52306-023, A52306-024, A52306-025, A52306-026, A52306-027, A52306-028, A52306-029, A52306-030, A52306-031, A52306-034, A52306-035, A52306-036, A52306-037, A52306-038, A52306-039, A52306-040, A52306-041, A52306-042, A52306-043, A52306-044, A52306-045, A52306-046, A52306-047, A52306-048, A52306-049, A52306-050, A52345-051, A52345-052, A52345-053, A52345-054, A52345-055, A52345-056, A52345-057, A52345-058, A52345-059, A52345-060, A52345-061, A52345-062, A52345-063, A52345-064, A52345-065, A52345-066, A52345-067, A52345-068, A52345-069, A52345-070, A52347-011, A52347-012, A52347-013, A52347-014, A52347-015, A52347-016, A52347-017, A52347-018, A52347-019, A52347-020, A52347-021, A52347-022, A52347-023, A52347-024, A52347-025, A52347-026, A52347-027, A52347-028...

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