Recall archive / FDA device enforcement

Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON,... — FDA record Z-1325-2023

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 Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT; d) DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100; e) DBM T42100AUS 2.5CMX10CM FLEX GRAFTON, REF T42100AUS; f) DBM T42100INT 2.5CMX10CM FLEX GRAFTON, REF T42100INT; g) DBM T42110 2.5CMX5CM FLEXGRAFTON, REF T42110; h) DBM T42110AUS 2.5CMX5CM FLEX GRAFTON, REF T42110AUS; i) DBM T42110INT 2.5CMX5CM FLEXGRAFTON, REF T42110INT; j) DBM T42150INT 5CM X 5CM FLEX GRAFTON, REF T42150INT; 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: 2987 units
Agency-reported status: Ongoing
Source record identifier: Z-1325-2023

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 S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090, GTIN 00613994961006, Serial Numbers: A50360, A52104, A55429; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090, GTIN 00643169122994, Serial Numbers: A40174-066, A40174-067, A40174-068, A40174-069, A40174-070, A40174-071, A40174-072, A40174-073, A40174-074, A40174-075, A40174-076, A40174-077, A40174-078, A40174-079, A42594-022, A42594-023, A42594-024, A42594-025, A42594-026, A42594-027, A42594-028, A42594-029, A42594-030, A42594-031, A42594-032, A42594-033, A42594-034, A42594-035, A42594-036, A42594-037, A42890-011, A42890-012, A42890-013, A42890-014, A42890-015, A42890-016, A42890-017, A42890-018, A42890-019, A42890-020, A42890-021, A42890-022, A42890-023, A42890-024, A43119-101, A43119-102, A43119-103, A43119-104, A43119-105, A43220-011, A43220-012, A44574-011, A44574-012, A44574-013, A44574-014, A44574-015, A44574-016, A44616-011, A44616-012, A44616-013, A44616-014, A44616-015, A44616-016, A44616-017, A44616-018, A44616-019, A44616-020, A44616-021, A44616-022, A44616-023, A44616-024, A44616-025, A44616-026, A44616-027, A44616-028, A44616-029, A44616-030, A44616-031, A44616-032, A44616-033, A44616-034, A44616-035, A44704-011, A44704-012, A44704-013, A44704-014, A44704-015, A44704-016, A44704-017, A44704-018, A44704-019, A44704-020, A44704-021, A44704-022, A44704-023, A44704-024, A45275-011, A45275-012, A45275-013, A45275-014, A45275-015, A45275-016, A45275-017, A45275-018, A45275-019, A45275-020, A45275-021, A45275-022, A45275-023, A45275-024, A45275-025, A45275-026, A45275-027, A45275-028, A45275-029, A45275-030, A45275-031, A45275-032, A45275-033, A45275-034, A45275-035, A45544-011, A45544-012, A45544-013, A45544-014, A45544-015, A45544-016, A45544-017, A45544-018, A45544-019, A45544-020, A45544-021, A45544-022, A45544-023, A45544-024, A45544-025, A46162-011, A46162-012, A46162-013, A46162-014, A46162-015, A46162-016, A46162-017, A46162-018, A46162-019, A46162-020, A46162-021, A46162-022, A46162-023, A46162-024, A46537-011, A46537-012, A46537-013, A46537-014, A46537-015, A46537-016, A46537-017, A46537-018, A46537-019, A46537-020, A46537-021, A46537-022, A46537-023, A46537-024, A46537-025, A46537-026, A46711-024, A46711-025, A46711-026, A46711-027, A46711-028, A46711-029, A46711-030, A46711-031, A46711-032, A46711-033, A46711-034, A46711-035, A46711-036, A46711-037, A47573-011, A47573-012, A47573-013, A47573-014, A48312-011, A48312-012, A48312-013, A48312-014, A48312-015, A48312-016, A48312-017, A48312-018, A48312-019, A48472-011, A48472-012, A48472-013, A48472-014, A48472-015, A48472-016, A48472-017, A48472-018, A48472-019, A48472-020, A48472-021, A48472-022, A48759-011, A48759-012, A48759-013, A48759-014, A48759-015, A48759-016, A48759-017, A48759-018, A48759-019, A48759-020, A48759-021, A48759-023, A48759-024, A48759-025, A48759-026, A49927-011, A49927-012, A49927-013, A49927-014, A49927-015, A49927-016, A49927-017, A49927-018, A49927-019, A49927-020, A49927-021, A49927-022, A49927-023, A51087-011, A51087-012, A51087-013, A51087-014, A51087-015, A51087-016, A51087-017, A51087-018, A51102-054, A51102-055, A51102-056, A51102-057, A51102-058, A51102-059, A51102-060, A51102-061, A52712-082, A52712-083, A52712-084, A52712-085, A52712-086, A52712-087, A52712-088, A52712-089, A52712-090, A52712-091, A52712-092, A52712-093, A52712-094, A52712-095, A52712-096, A52712-097, A52712-098, A52712-099, A52712-100, A53148-011, A53148-012, A53148-013, A53148-014, A53148-015, A53284-026, A53284-027, A53284-028, A53284-029, A53284-030, A53284-031, A53284-032, A53284-033, A53284-034, A53284-035, A53284-036, A53284-037, A53284-038, A53284-039, A53284-040, A53284-041, A53284-042, A53284-043, A53284-044, A53284-045, A53284-046, A53770-011, A53770-012, A53770-013, A53770-014, A53770-015, A53770-016, A53770-017, A53770-018, A53770-019, A53770-020, A53770-021, A53770-022, A53770-023, A54399-043, A54399-044, A54399-045, A54399-046, A54399-047, A54399-048, A54399-049, A54399-050, A54399-051, A54399-052, A54399-053, A54399-054, A54399-055, A54399-056, A54399-057, A55095-050, A55095-051, A55095-052, A55095-053, A55095-054, A55095-055, A55095-056, A55095-057, A55095-058, A55095-059, A55095-060, A55095-061, A55095-062, A55095-063, A55095-064, A55095-065, A55095-066, A55095-067; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT, GTIN 00643169964877, Serial Numbers: A42232-041, A42232-042, A42232-043, A42232-044, A42232-045, A42232-046, A42232-047, A42232-048, A42232-049, A42232-050, A42232-051, A42232-052, A42232-053, A42232-054, A42232-055, A42232-056, A42232-057, A42232-058, A42232-059, A42232-060, A42232-061, A42232-062, A42232-063, A42851-038, A42851-039, A42851-040, A42851-041, A42851-042, A42851-043, A42851-044, A42851-045, A42851-046, A42851-047, A42851-048, A42851-049, A42851-050, A42851-051, A42851-052, A43708-049, A43708-050, A43708-051, A43708-052, A43708-053, A43708-054, A43708-055, A43708-056, A43708-057, A43708-058, A43708-059, A43708-060, A43708-061, A43708-062, A43708-063, A43708-064, A43708-065, A43708-066, A43708-067, A43708-068, A43708-069, A43708-070, A43708-071, A43708-072, A43708-073, A43708-074, A43708-075, A43708-076, A43708-077, A43708-078, A43708-079, A43708-080, A43708-082, A43708-083, A43708-084, A43708-085, A43708-086, A43708-087, A43708-088, A43708-089, A43708-090, A43708-092, A43708-093, A43708-094, A43708-095, A43708-096, A43708-099, A43708-101, A43708-102, A43708-103, A43708-104, A44398-011, A44398-012, A44398-013, A44398-014, A44398-015, A44398-016, A44398-017, A44398-018, A44398-019, A44398-020, A44398-021, A44398-022, A44398-023, A44398-024, A44398-025, A44398-026, A44398-027, A44398-028, A44398-029, A44398-030, A44398-031, A44398-032, A44398-033, A44398-034, A44398-035, A44704-025, A44704-026, A44704-027, A44704-028, A44704-029, A44704-030, A44704-031, A44704-032, A44704-033, A44704-034, A44704-035, A44704-036, A44704-037, A44704-038, A45772-011, A45772-012, A45772-013, A45772-014, A45772-015, A45826-011, A45826-012, A45826-013, A45826-014, A45898-023, A45898-024, A45898-025, A45898-026, A47573-029, A47832-021, A48759-039, A52104-039, A52104-040, A52104-041, A52104-042, A52104-043, A52104-044, A52104-045, A52104-047, A52104-048, A52104-049, A52104-050, A52104-051, A52104-052, A52104-053, A52104-054, A52104-055, A53050-011, A53050-012, A53050-013, A53050-014, A53050-015, A53050-016, A53050-017, A53050-018, A53050-019, A53050-020, A55429-021; d) DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100, GTIN 00643169123007, Serial Numbers: A41864-011, A41864-012, A41864-013, A41864-014, A41864-015, A41864-016, A41864-017, A41864-018, A41864-019, A41864-020, A41864-021, A42890-025, A42890-026, A42890-027, A42890-028, A42890-029, A42890-030, A42890-031, A42890-032, A42890-033, A42890-034, A42890-035, A42890-036, A42890-037, A42890-038, A42964-021, A42964-022, A42964-023, A42964-024, A42964-025, A42964-026, A42964-027, A42964-028, A42964-029, A42972-061, A42972-062, A42972-063, A42972-064, A42972-065, A42972-066, A42972-067, A42972-068, A42972-069, A42972-070, A42972-071, A42972-072, A42972-073, A42972-074, A42972-075, A42972-076, A43119-106, A43119-107, A43119-108, A43119-109, A43119-110, A43119-111, A43119-112, A43119-113, A43119-114, A43119-115, A43119-116, A43119-117, A43119-118, A43155-016, A43155-017, A43155-018, A43155-019, A43155-020, A43155-021, A43155-022, A43155-023, A43155-024, A43155-025, A43155-026, A43281-030, A43281-031, A43281-032, A43281-033, A43281-034, A43281-035, A43281-036, A43281-037, A43281-038, A43281-039, A43281-040, A43403-011, A43403-012, A43403-013, A43403-014, A43403-015, A43403-016, A43403-017, A43403-018, A43403-019, A43403-020, A43403-021, A43403-022, A43403-023, A43403-024, A43403-025, A43708-105, A43708-106, A43708-107, A43708-108, A43708-109, A43708-110, A44100-011, A44100-012, A44100-013, A44100-014, A44100-015, A44100-016, A44100-017, A44100-018, A44100-019, A44100-020, A44100-021, A44100-022, A44100-023, A44100-024, A44100-025, A44118-011, A44118-012, A44118-013, A44118-014, A44118-015, A44118-016, A44118-017, A44118-018, A44118-019, A44118-020, A44118-021, A44118-022, A44118-023, A44118-024, A44290-011, A44290-012, A44290-013, A44290-014, A44290-015, A44290-016, A44290-017, A44290-018, A44290-019, A44290-020, A44290-021, A44290-022, A44290-023, A44290-024, A44290-025, A44290-026, A44311-011, A44311-012, A44311-013, A44311-014, A44311-015, A44311-016, A44311-017, A44311-018, A44311-019, A44311-020, A44311-021, A44311-022, A44311-023, A44311-024, A44311-025, A44372-129, A44372-130, A44372-131, A44372-132, A44372-133, A44372-134, A44372-135, A44372-136, A44372-137, A44372-138, A44372-139, A44372-140, A44372-141, A44372-142, A44372-143, A44412-060, A44412-061, A44412-062, A44412-063, A44412-064, A44412-065, A44412-066, A44412-067, A44412-068, A44412-069, A44412-070, A44412-071, A44412-072, A44412-073, A44412-074, A44655-046, A44655-047, A44655-048, A44655-049, A44655-050, A44655-051, A44655-052, A44655-053, A44655-054, A44655-055, A44655-056, A44655-057, A44655-058, A44764-011, A44764-012, A44764-013, A44764-014, A44764-015, A44764-016, A44764-017, A44764-018, A44764-019, A44764-020, A45256-011, A45256-012, A45256-013, A45256-014, A45256-015, A45256-016, A45256-017, A45256-018, A45256-019, A45256-020, A45256-021, A45256-022, A45256-023, A45256-024, A45256-025, A45281-117, A45281-118, A45281-119, A45281-120, A45281-121, A45281-122, A45281-123, A45281-124, A45281-125, A45281-126, A45281-127, A45281-128, A45281-129, A45281-130, A45281-131, A45512-011, A45512-012, A45521-011, A45521-012, A45521-013, A45521-014, A45521-015, A45521-016, A45521-017, A45521-018, A45521-019, A45521-020, A45521-021, A45521-022, A45521-023, A45521-024, A45521-025, A45521-026, A45544-026, A45544-027, A45544-028, A45544-029, A45544-030, A45544-031, A45544-032, A45544-033, A45544-034, A45544-035, A45544-036, A45544-037, A45544-038, A45544-039, A45572-033, A45572-034, A45572-035, A45572-036, A45572-037, A45572-038, A45572-039, A45572-040, A45572-041, A45572-042, A45572-043, A45572-044, A45572-045, A45572-046, A45572-047, A45579-021, A45579-022, A45579-023, A45579-024, A45579-025, A45579-026, A45579-027, A45579-028, A45579-029, A45579-030, A45579-031, A45579-032, A45579-033, A45579-034, A45579-035, A45581-036, A45581-037, A45581-038, A45581-039, A45581-040, A45581-041, A45581-042, A45581-043, A45581-044, A45581-045, A45581-046, A45581-047, A45581-048, A45581-049, A45581-050, A45581-051, A45703-011, A45703-012, A45703-013, A45703-014, A45703-015, A45703-016, A45703-017, A45703-018, A45703-019, A45703-020, A45703-021, A45703-022, A45703-023, A45703-024, A45703-025, A45703-026, A45970-011, A45970-012, A45970-013, A45970-014, A45970-015, A45970-016, A45970-017, A45970-018, A45970-019, A45970-020, A45970-021, A45970-022, A45970-023, A45970-024, A45970-025, A45970-026, A46023-031, A46023-032, A46023-033, A46023-034, A46023-035, A46023-036, A46023-037, A46023-038, A46023-039, A46023-040, A46023-041, A46023-042, A46044-058, A46044-059, A46044-060, A46044-061, A46044-062, A46044-063, A46044-064, A46044-065, A46044-066, A46044-067, A46044-068, A46044-069, A46044-070, A46044-071, A46162-025, A46162-026, A46162-027, A46162-028, A46162-029, A46162-030, A46162-031, A46162-032, A46162-033, A46162-034, A46162-035, A46162-036, A46162-037, A46162-038, A46537-027, A46537-028, A46537-029, A46537-030, A46537-031, A46537-032, A46537-033, A46537-034, A46537-035, A46537-036, A46537-037, A46537-038, A46537-039, A46537-040, A46537-041, A46537-042, A46537-043, A46537-044, A46537-045, A46537-046, A46537-047, A46537-048, A46537-049, A46537-050, A46552-011, A46552-012, A46552-013, A46552-014, A46552-015, A46552-016, A46552-017, A46552-018, A46552-019, A46552-020, A46552-021, A46552-022, A46552-023, A46552-024, A46583-011, A46583-012, A46583-013, A46583-014, A46583-015, A46583-016, A46583-017, A46583-018, A46583-019, A46583-020, A46583-021, A46711-038, A46711-039, A46711-040, A46711-041, A46711-042, A46711-043, A46711-044, A46711-045, A46711...

Label field

Details supplied by the agency

Lot, code or applicability

a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090, GTIN 00613994961006, Serial Numbers: A50360, A52104, A55429; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090, GTIN 00643169122994, Serial Numbers: A40174-066, A40174-067, A40174-068, A40174-069, A40174-070, A40174-071, A40174-072, A40174-073, A40174-074, A40174-075, A40174-076, A40174-077, A40174-078, A40174-079, A42594-022, A42594-023, A42594-024, A42594-025, A42594-026, A42594-027, A42594-028, A42594-029, A42594-030, A42594-031, A42594-032, A42594-033, A42594-034, A42594-035, A42594-036, A42594-037, A42890-011, A42890-012, A42890-013, A42890-014, A42890-015, A42890-016, A42890-017, A42890-018, A42890-019, A42890-020, A42890-021, A42890-022, A42890-023, A42890-024, A43119-101, A43119-102, A43119-103, A43119-104, A43119-105, A43220-011, A43220-012, A44574-011, A44574-012, A44574-013, A44574-014, A44574-015, A44574-016, A44616-011, A44616-012, A44616-013, A44616-014, A44616-015, A44616-016, A44616-017, A44616-018, A44616-019, A44616-020, A44616-021, A44616-022, A44616-023, A44616-024, A44616-025, A44616-026, A44616-027, A44616-028, A44616-029, A44616-030, A44616-031, A44616-032, A44616-033, A44616-034, A44616-035, A44704-011, A44704-012, A44704-013, A44704-014, A44704-015, A44704-016, A44704-017, A44704-018, A44704-019, A44704-020, A44704-021, A44704-022, A44704-023, A44704-024, A45275-011, A45275-012, A45275-013, A45275-014, A45275-015, A45275-016, A45275-017, A45275-018, A45275-019, A45275-020, A45275-021, A45275-022, A45275-023, A45275-024, A45275-025, A45275-026, A45275-027, A45275-028, A45275-029, A45275-030, A45275-031, A45275-032, A45275-033, A45275-034, A45275-035, A45544-011, A45544-012, A45544-013, A45544-014, A45544-015, A45544-016, A45544-017, A45544-018, A45544-019, A45544-020, A45544-021, A45544-022, A45544-023, A45544-024, A45544-025, A46162-011, A46162-012, A46162-013, A46162-014, A46162-015, A46162-016, A46162-017, A46162-018, A46162-019, A46162-020, A46162-021, A46162-022, A46162-023, A46162-024, A46537-011, A46537-012, A46537-013, A46537-014, A46537-015, A46537-016, A46537-017, A46537-018, A46537-019, A46537-020, A46537-021, A46537-022, A46537-023, A46537-024, A46537-025, A46537-026, A46711-024, A46711-025, A46711-026, A46711-027, A46711-028, A46711-029, A46711-030, A46711-031, A46711-032, A46711-033, A46711-034, A46711-035, A46711-036, A46711-037, A47573-011, A47573-012, A47573-013, A47573-014, A48312-011, A48312-012, A48312-013, A48312-014, A48312-015, A48312-016, A48312-017, A48312-018, A48312-019, A48472-011, A48472-012, A48472-013, A48472-014, A48472-015, A48472-016, A48472-017, A48472-018, A48472-019, A48472-020, A48472-021, A48472-022, A48759-011, A48759-012, A48759-013, A48759-014, A48759-015, A48759-016, A48759-017, A48759-018, A48759-019, A48759-020, A48759-021, A48759-023, A48759-024, A48759-025, A48759-026, A49927-011, A49927-012, A49927-013, A49927-014, A49927-015, A49927-016, A49927-017, A49927-018, A49927-019, A49927-020, A49927-021, A49927-022, A49927-023, A51087-011, A51087-012, A51087-013, A51087-014, A51087-015, A51087-016, A51087-017, A51087-018, A51102-054, A51102-055, A51102-056, A51102-057, A51102-058, A51102-059, A51102-060, A51102-061, A52712-082, A52712-083, A52712-084, A52712-085, A52712-086, A52712-087, A52712-088, A52712-089, A52712-090, A52712-091, A52712-092, A52712-093, A52712-094, A52712-095, A52712-096, A52712-097, A52712-098, A52712-099, A52712-100, A53148-011, A53148-012, A53148-013, A53148-014, A53148-015, A53284-026, A53284-027, A53284-028, A53284-029, A53284-030, A53284-031, A53284-032, A53284-033, A53284-034, A53284-035, A53284-036, A53284-037, A53284-038, A53284-039, A53284-040, A53284-041, A53284-042, A53284-043, A53284-044, A53284-045, A53284-046, A53770-011, A53770-012, A53770-013, A53770-014, A53770-015, A53770-016, A53770-017, A53770-018, A53770-019, A53770-020, A53770-021, A53770-022, A53770-023, A54399-043, A54399-044, A54399-045, A54399-046, A54399-047, A54399-048, A54399-049, A54399-050, A54399-051, A54399-052, A54399-053, A54399-054, A54399-055, A54399-056, A54399-057, A55095-050, A55095-051, A55095-052, A55095-053, A55095-054, A55095-055, A55095-056, A55095-057, A55095-058, A55095-059, A55095-060, A55095-061, A55095-062, A55095-063, A55095-064, A55095-065, A55095-066, A55095-067; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT, GTIN 00643169964877, Serial Numbers: A42232-041, A42232-042, A42232-043, A42232-044, A42232-045, A42232-046, A42232-047, A42232-048, A42232-049, A42232-050, A42232-051, A42232-052, A42232-053, A42232-054, A42232-055, A42232-056, A42232-057, A42232-058, A42232-059, A42232-060, A42232-061, A42232-062, A42232-063, A42851-038, A42851-039, A42851-040, A42851-041, A42851-042, A42851-043, A42851-044, A42851-045, A42851-046, A42851-047, A42851-048, A42851-049, A42851-050, A42851-051, A42851-052, A43708-049, A43708-050, A43708-051, A43708-052, A43708-053, A43708-054, A43708-055, A43708-056, A43708-057, A43708-058, A43708-059, A43708-060, A43708-061, A43708-062, A43708-063, A43708-064, A43708-065, A43708-066, A43708-067, A43708-068, A43708-069, A43708-070, A43708-071, A43708-072, A43708-073, A43708-074, A43708-075, A43708-076, A43708-077, A43708-078, A43708-079, A43708-080, A43708-082, A43708-083, A43708-084, A43708-085, A43708-086, A43708-087, A43708-088, A43708-089, A43708-090, A43708-092, A43708-093, A43708-094, A43708-095, A43708-096, A43708-099, A43708-101, A43708-102, A43708-103, A43708-104, A44398-011, A44398-012, A44398-013, A44398-014, A44398-015, A44398-016, A44398-017, A44398-018, A44398-019, A44398-020, A44398-021, A44398-022, A44398-023, A44398-024, A44398-025, A44398-026, A44398-027, A44398-028, A44398-029, A44398-030, A44398-031, A44398-032, A44398-033, A44398-034, A44398-035, A44704-025, A44704-026, A44704-027, A44704-028, A44704-029, A44704-030, A44704-031, A44704-032, A44704-033, A44704-034, A44704-035, A44704-036, A44704-037, A44704-038, A45772-011, A45772-012, A45772-013, A45772-014, A45772-015, A45826-011, A45826-012, A45826-013, A45826-014, A45898-023, A45898-024, A45898-025, A45898-026, A47573-029, A47832-021, A48759-039, A52104-039, A52104-040, A52104-041, A52104-042, A52104-043, A52104-044, A52104-045, A52104-047, A52104-048, A52104-049, A52104-050, A52104-051, A52104-052, A52104-053, A52104-054, A52104-055, A53050-011, A53050-012, A53050-013, A53050-014, A53050-015, A53050-016, A53050-017, A53050-018, A53050-019, A53050-020, A55429-021; d) DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100, GTIN 00643169123007, Serial Numbers: A41864-011, A41864-012, A41864-013, A41864-014, A41864-015, A41864-016, A41864-017, A41864-018, A41864-019, A41864-020, A41864-021, A42890-025, A42890-026, A42890-027, A42890-028, A42890-029, A42890-030, A42890-031, A42890-032, A42890-033, A42890-034, A42890-035, A42890-036, A42890-037, A42890-038, A42964-021, A42964-022, A42964-023, A42964-024, A42964-025, A42964-026, A42964-027, A42964-028, A42964-029, A42972-061, A42972-062, A42972-063, A42972-064, A42972-065, A42972-066, A42972-067, A42972-068, A42972-069, A42972-070, A42972-071, A42972-072, A42972-073, A42972-074, A42972-075, A42972-076, A43119-106, A43119-107, A43119-108, A43119-109, A43119-110, A43119-111, A43119-112, A43119-113, A43119-114, A43119-115, A43119-116, A43119-117, A43119-118, A43155-016, A43155-017, A43155-018, A43155-019, A43155-020, A43155-021, A43155-022, A43155-023, A43155-024, A43155-025, A43155-026, A43281-030, A43281-031, A43281-032, A43281-033, A43281-034, A43281-035, A43281-036, A43281-037, A43281-038, A43281-039, A43281-040, A43403-011, A43403-012, A43403-013, A43403-014, A43403-015, A43403-016, A43403-017, A43403-018, A43403-019, A43403-020, A43403-021, A43403-022, A43403-023, A43403-024, A43403-025, A43708-105, A43708-106, A43708-107, A43708-108, A43708-109, A43708-110, A44100-011, A44100-012, A44100-013, A44100-014, A44100-015, A44100-016, A44100-017, A44100-018, A44100-019, A44100-020, A44100-021, A44100-022, A44100-023, A44100-024, A44100-025, A44118-011, A44118-012, A44118-013, A44118-014, A44118-015, A44118-016, A44118-017, A44118-018, A44118-019, A44118-020, A44118-021, A44118-022, A44118-023, A44118-024, A44290-011, A44290-012, A44290-013, A44290-014, A44290-015, A44290-016, A44290-017, A44290-018, A44290-019, A44290-020, A44290-021, A44290-022, A44290-023, A44290-024, A44290-025, A44290-026, A44311-011, A44311-012, A44311-013, A44311-014, A44311-015, A44311-016, A44311-017, A44311-018, A44311-019, A44311-020, A44311-021, A44311-022, A44311-023, A44311-024, A44311-025, A44372-129, A44372-130, A44372-131, A44372-132, A44372-133, A44372-134, A44372-135, A44372-136, A44372-137, A44372-138, A44372-139, A44372-140, A44372-141, A44372-142, A44372-143, A44412-060, A44412-061, A44412-062, A44412-063, A44412-064, A44412-065, A44412-066, A44412-067, A44412-068, A44412-069, A44412-070, A44412-071, A44412-072, A44412-073, A44412-074, A44655-046, A44655-047, A44655-048, A44655-049, A44655-050, A44655-051, A44655-052, A44655-053, A44655-054, A44655-055, A44655-056, A44655-057, A44655-058, A44764-011, A44764-012, A44764-013, A44764-014, A44764-015, A44764-016, A44764-017, A44764-018, A44764-019, A44764-020, A45256-011, A45256-012, A45256-013, A45256-014, A45256-015, A45256-016, A45256-017, A45256-018, A45256-019, A45256-020, A45256-021, A45256-022, A45256-023, A45256-024, A45256-025, A45281-117, A45281-118, A45281-119, A45281-120, A45281-121, A45281-122, A45281-123, A45281-124, A45281-125, A45281-126, A45281-127, A45281-128, A45281-129, A45281-130, A45281-131, A45512-011, A45512-012, A45521-011, A45521-012, A45521-013, A45521-014, A45521-015, A45521-016, A45521-017, A45521-018, A45521-019, A45521-020, A45521-021, A45521-022, A45521-023, A45521-024, A45521-025, A45521-026, A45544-026, A45544-027, A45544-028, A45544-029, A45544-030, A45544-031, A45544-032, A45544-033, A45544-034, A45544-035, A45544-036, A45544-037, A45544-038, A45544-039, A45572-033, A45572-034, A45572-035, A45572-036, A45572-037, A45572-038, A45572-039, A45572-040, A45572-041, A45572-042, A45572-043, A45572-044, A45572-045, A45572-046, A45572-047, A45579-021, A45579-022, A45579-023, A45579-024, A45579-025, A45579-026, A45579-027, A45579-028, A45579-029, A45579-030, A45579-031, A45579-032, A45579-033, A45579-034, A45579-035, A45581-036, A45581-037, A45581-038, A45581-039, A45581-040, A45581-041, A45581-042, A45581-043, A45581-044, A45581-045, A45581-046, A45581-047, A45581-048, A45581-049, A45581-050, A45581-051, A45703-011, A45703-012, A45703-013, A45703-014, A45703-015, A45703-016, A45703-017, A45703-018, A45703-019, A45703-020, A45703-021, A45703-022, A45703-023, A45703-024, A45703-025, A45703-026, A45970-011, A45970-012, A45970-013, A45970-014, A45970-015, A45970-016, A45970-017, A45970-018, A45970-019, A45970-020, A45970-021, A45970-022, A45970-023, A45970-024, A45970-025, A45970-026, A46023-031, A46023-032, A46023-033, A46023-034, A46023-035, A46023-036, A46023-037, A46023-038, A46023-039, A46023-040, A46023-041, A46023-042, A46044-058, A46044-059, A46044-060, A46044-061, A46044-062, A46044-063, A46044-064, A46044-065, A46044-066, A46044-067, A46044-068, A46044-069, A46044-070, A46044-071, A46162-025, A46162-026, A46162-027, A46162-028, A46162-029, A46162-030, A46162-031, A46162-032, A46162-033, A46162-034, A46162-035, A46162-036, A46162-037, A46162-038, A46537-027, A46537-028, A46537-029, A46537-030, A46537-031, A46537-032, A46537-033, A46537-034, A46537-035, A46537-036, A46537-037, A46537-038, A46537-039, A46537-040, A46537-041, A46537-042, A46537-043, A46537-044, A46537-045, A46537-046, A46537-047, A46537-048, A46537-049, A46537-050, A46552-011, A46552-012, A46552-013, A46552-014, A46552-015, A46552-016, A46552-017, A46552-018, A46552-019, A46552-020, A46552-021, A46552-022, A46552-023, A46552-024, A46583-011, A46583-012, A46583-013, A46583-014, A46583-015, A46583-016, A46583-017, A46583-018, A46583-019, A46583-020, A46583-021, A46711-038, A46711-039, A46711-040, A46711-041, A46711-042, A46711-043, A46711-044, A46711-045, A46711...

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

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