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Lower risk Medical device recall · FDA · Published July 12, 2023

Medicrea IMPIX S Device Recall: Pinhole Packaging Issue

Medicrea recalls IMPIX S spinal fusion devices with specific reference numbers due to potential pinhole in packaging pouches. Affected units may have packaging defects that could lead to product contamination.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2461-2023Medical deviceMedicrea ›
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Recalling firmMedicrea InternationalVancia, Vancia · Rillieux La Pape, France
✎ GovInfoNow plain-language explainer

Medicrea is recalling specific IMPIX S spinal fusion devices that have a potential pinhole in the packaging pouch. This issue could lead to product contamination if the device is exposed to moisture or other contaminants. Read more at govinfonow.com/recall/57683-medicrea-impix-s-device-recall-pinhole-packaging-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/57683-medicrea-impix-s-device-recall-pinhole-packaging-issue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2461-2023

Cite this page

“Medicrea IMPIX S Device Recall: Pinhole Packaging Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57683-medicrea-impix-s-device-recall-pinhole-packaging-issue. Based on FDA recall #Z-2461-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2461-2023%22&limit=1).

The FDA announced on July 12, 2023, that Medicrea International is recalling IMPIX S intervertebral fusion devices due to potential packaging non-conformities. The hazard involves pinholes in the inner or outer pouches of the product.

How to tell if you have it

  • Brand: Medicrea
  • Product: IMPIX S
  • REF numbers: B15328071S, B15328073S, B15328074S, B15334072S, B15334073S, B15334074S
  • GTINs: 03613720195535, 03613720195573, 03613720195597, 03613720195832, 03613720195856, 03613720195870
  • Lot numbers: 19I0696, 20A0759, 20B0747, 19I0698, 19I0557, 20F0185, 19J0947, 19E0502, 19J0091, 20F0184
  • Distribution: US nationwide

The hazard

According to the FDA, there is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Context

GovInfoNow's records show Medicrea International has 8 other recalls on record since June 27, 2019. Recent brand recalls include the Oct. 29, 2025, IB3D Universal Implant Inserter recall for handle issues and the Dec. 3, 2024, UNiD Spine Analyzer Software Error recall. Other recent recalls of similar products include the April 21, 2026, Medtronic GUNDRY Cannula Recall and the Nov. 13, 2025, Medline Forceps Recall.

How to tell if you have this one

Check the reference numbers listed: B15328071S, B15328073S, B15328074S, B15334072S, B15334073S, or B15334074S. Also look for the specific lot numbers associated with each reference number.

  • Brand
    Medicrea
  • Product
    IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S
  • Category
    Medical device
FDA recall event · 11 products

All 11 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US nationwide
Recall numberProduct, codes & lotsQuantity
Z-2452-2023IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j) B242C13122810, k) B242C14122810, l) B242C15122810, m) B247C07062410, n) B247C07062810, o) B247C07063210, p) B247C08062410, q) B247C08062810, r) B247C08063210, s) B247C09062410, t) B247C09062810, u) B247C09063210, v) B247C10062410, w) B247C10062810, x) B247C10063210, y) B247C11062410, z) B247C11062810, aa) B247C11063210, bb) B247C12062410, cc) B247C12062810, dd) B247C12063210, ee) B247C13062410, ff) B247C13062810, gg) B247C13063210, hh) B247C14062410, ii) B247C14062810, jj) B247C14063210, kk) B247C15062810, ll) B247C15063210; intervertebral fusion device - lumbar; a) B242C09122810, GTIN 03613720284444, Lot Numbers: 20B0926, 20B0984; b) B242C10062810, GTIN 03613720270522, Lot Numbers: 18E0499; c) B242C10122810, GTIN 03613720284451, Lot Numbers: 20B0928, 20B0985; d) B242C11062810, GTIN 03613720270539, Lot Numbers: 18D0708, 19F0261; e) B242C11122810, GTIN 03613720284468, Lot Numbers: 20B0930, 20B0986; f) B242C12062810, GTIN 03613720270546, Lot Numbers: 18D0709, 19G0038; g) B242C12122810, GTIN 03613720284475, Lot Numbers: 20B0931, 20B0987; h) B242C12123310, GTIN 03613720284543, Lot Numbers: 20C0374; i) B242C13062810, GTIN 03613720270553, Lot Numbers: 18D0710, 19F0263; j) B242C13122810, GTIN 03613720284482, Lot Numbers: 20E0343; k) B242C14122810, GTIN 03613720284499, Lot Numbers: 20B0932; l) B242C15122810, GTIN 03613720284505, Lot Numbers: 20B0933; m) B247C07062410, GTIN 03613720272762, Lot Numbers: 18D0965, 18I0576, 18L0085; n) B247C07062810, GTIN 03613720272779, Lot Numbers: 18I0577, 18L0084; o) B247C07063210, GTIN 03613720272786, Lot Numbers: 18I0492; p) B247C08062410, GTIN 03613720272533, Lot Numbers: 18D0966, 18I0579, 18L0086; q) B247C08062810, GTIN 03613720272526, Lot Numbers: 18I0554, 18I0580; r) B247C08063210, GTIN 03613720272540, Lot Numbers: 18I0493; s) B247C09062410, GTIN 03613720272557, Lot Numbers: 18D0967, 18I0582, 18L0088, 19F0264; t) B247C09062810, GTIN 03613720272564, Lot Numbers: 18H0611R, 18H0611R/1, 18I0555; u) B247C09063210, GTIN 03613720272571, Lot Numbers: 18I0494; v) B247C10062410, GTIN 03613720272588, Lot Numbers: 18D0968, 18I0584, 18L0089, 20A0451; w) B247C10062810, GTIN 03613720272595, Lot Numbers: 18H0612, 18H0612/1, 18H0612/2; x) B247C10063210, GTIN 03613720272601, Lot Numbers: 18I0495; y) B247C11062410, GTIN 03613720272618, Lot Numbers: 18D0969, 18I0586, 19F0265; z) B247C11062810, GTIN 03613720272625, Lot Numbers: 18H0613, 18H0613/1; aa) B247C11063210, GTIN 03613720272632, Lot Numbers: 18I0496; bb) B247C12062410, GTIN 03613720272649, Lot Numbers: 18D0970; cc) B247C12062810, GTIN 03613720272656, Lot Numbers: 18H0614, 18I0558; dd) B247C12063210, GTIN 03613720272663, Lot Numbers: 18I0560; ee) B247C13062410, GTIN 03613720272670, Lot Numbers: 18I0589; ff) B247C13062810, GTIN 03613720272687, Lot Numbers: 18H0615; gg) B247C13063210, GTIN 03613720272694, Lot Numbers: 18I0561; hh) B247C14062410, GTIN 03613720272700, Lot Numbers: 18L0099; ii) B247C14062810, GTIN 03613720272717, Lot Numbers: 18H0616/1/1, 18H0616/2; jj) B247C14063210, GTIN 03613720272724, Lot Numbers: 18I0562; kk) B247C15062810, GTIN 03613720272748, Lot Numbers: 18I0498; ll) B247C15063210, GTIN 03613720272755, Lot Numbers: 18I0563248 units
Z-2453-2023IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar; a) B15111209, GTIN 03613720193395, Lot Numbers: 19C0772; b) B15111212, GTIN 03613720193401, Lot Numbers: 19C0775, 19G0070; c) B15111409, GTIN 03613720193425, Lot Numbers: 19E0353; d) B15111412, GTIN 03613720193432, Lot Numbers: 19C078811 units
Z-2454-2023IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar; GTIN 03613720264439, Lot Numbers: 18I0824, 19L00465 units
Z-2455-2023IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; intervertebral fusion device - lumbar; a) B16123509, GTIN 03613720196341, Lot Numbers: 20B0490; b) B16123511, GTIN 03613720196358, Lot Numbers: 19G0068; c) B16124009, GTIN 03613720196396, Lot Numbers: 19K0269; d) B16124013, GTIN 03613720196419, Lot Numbers: 19F0715; e) B16124509, GTIN 03613720196440, Lot Numbers: 19F0713; f) B16124511, GTIN 03613720196457, Lot Numbers: 19F0716; g) B16124513, GTIN 03613720196464, Lot Numbers: 19K0270; h) B16164009, GTIN 03613720196495, Lot Numbers: 18F1034; i) B16164013, GTIN 03613720196518, Lot Numbers: 18G0178; j) B16165009, GTIN 03613720196594, Lot Numbers: 18C0626; k) B16165013, GTIN 03613720196617, Lot Numbers: 18C0629;24 units
Z-2456-2023IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B20182253, m) B20182263; intervertebral fusion device - lumbar; a) A20150407, GTIN 03613720236016, Lot Numbers: 18F0803, 18J0713, 18J0714, 19A0225, 19A0786, 19A0787, 19D0381, 19D0382, 19J0594, 20A0280, 20H0285, 20I0475, 20K0424, 21D0442, 21I0596, 22E0637; b) A20250407, GTIN 03613720236078, Lot Numbers: 18E0532, 18I0840, 18I0841, 18K0067, 18K0068, 18L0399, 19A0371, 19A0372, 19C0587, 19D0383, 19D0384, 19J0592, 19J0746, 19K0731, 19K0853, 20A0281, 20C0260, 20F0920, 20H0286, 20I0476, 20J0558, 20K0425, 21D0858, 21F0990, 21I0598, 22C0262, 22C0268, 22D0732, 22E0638, 22E0640, 22E0642, 22E0656, 22F0408, 22F0409; c) A20350567, GTIN 03613720236108, Lot Numbers: 18K0069, 19B0752, 19D0745, 20A0279, 20F0922, 20I0477, 21D0443, 21G0784, 22D0733, 22G0683; d) B20181743, GTIN 03613720233251, Lot Numbers: 19D0208, 19E0604, 19K0588; e) B20181753, GTIN 03613720233275, Lot Numbers: 20G0209, 20I0486, 20L0199, 21C0843; f) B20181763, GTIN 03613720233305, Lot Numbers: 18L0570, 19D0100, 19G0205, 19J0470, 20A0645; g) B20181773, GTIN 03613720233336, Lot Numbers: 19A0830, 19J0611, 19L0612, 20I0831; h) B20181943, GTIN 03613720233442, Lot Numbers: 19K0878, 20E0094, 21G0420; i) B20181953, GTIN 03613720233466, Lot Numbers: 21K0501; j) B20181963, GTIN 03613720233497, Lot Numbers: 21K0502; k) B20181973, GTIN 03613720233527, Lot Numbers: 21C0844; l) B20182253, GTIN 03613720233657, Lot Numbers: 19J0471, 19J0711, 20I0832; m) B20182263, GTIN 03613720233688, Lot Numbers: 22D08114489 units
Z-2457-2023IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar; a) B15130607S, GTIN 03613720245681, Lot Numbers: 19B0894, 19C0092, 19G0921, 19G0922, 19L0045, 20B0320, 20B0477, 20B0478, 20B0479; b) B15130609S, GTIN 03613720245674, Lot Numbers: 18D1077, 19J0690, 20A0042, 20A0423, 20A1000, 20B0322, 20B0476, 20F0908, 20H0481, 20I0099, 20J0734; c) B15130611S, GTIN 03613720193760, Lot Numbers: 19B0895, 19D0071, 19E0170, 19I0695, 19J0324, 20A0228, 20B0731, 20B0732; d) B15130613S, GTIN 03613720193784, Lot Numbers: 18G0602, 18I0594, 19C0091, 19F0641, 19L0032, 20F0909; e) B15130615S, GTIN 03613720193807, Lot Numbers: 20I0097; f) B15900806, GTIN 03613720275572, Lot Numbers: 19A0329R; g) B15900906, GTIN 03613720275589, Lot Numbers: 19A0340R; h) B15901006, GTIN 03613720275596, Lot Numbers: 19A0339R; i) B15901106, GTIN 03613720275602, Lot Numbers: 19A0338R, 19G0337; j) B15901206, GTIN 03613720275619, Lot Numbers: 19A0337R; k) B15901306, GTIN 03613720275626, Lot Numbers: 19A0336R730 units
Z-2458-2023PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical; a) B02315535Z, GTIN 03613720185086, Lot Numbers: 21J0184; b) B02315540Z, GTIN 03613720185116, Lot Numbers: 18E0322, 18F1011, 18G0704, 18I0780, 18K0862, 19B0091, 19B0731, 19D0267, 19F0460, 19J0742, 20A0966, 20F0008, 20I0200, 20I0833, 22I0616; c) B02315545Z, GTIN 03613720185147, Lot Numbers: 18H0617, 18I0682, 18J0215, 18K0863, 19K0545, 20H0147; d) B02315550Z, GTIN 03613720185178, Lot Numbers: 19E0306, 20F0009; e) B02316535Z, GTIN 03613720185321, Lot Numbers: 21J0185, 21J0899; f) B02316540Z, GTIN 03613720185352, Lot Numbers: 18E0478, 18H0672, 18K0278, 18K0864, 19A0645, 19B0318, 19B0777, 19C0417, 19C0739, 19E0082, 19I0573, 20A0596, 20B0687, 20H0148, 20J0414, 21A0107, 22A0297, 22I0339; g) B02316545Z, GTIN 03613720185383, Lot Numbers: 18D1035, 18E0508, 18F0534, 18G0170, 18G0591, 18H0588, 18J0054, 18K0279, 18K0865, 19A0066, 19B0093, 19B0912, 19C0138, 19D0177, 19E0084, 19G0188, 19J0227, 19J0228, 19K0764, 19L0360, 19L0580, 20B0688, 20H0151, 20J0415, 20L0238, 21A0109, 21A0642, 21D0174, 21F0505, 21L0394, 22A0047, 22L0091; h) B02316550Z, GTIN 03613720185413, Lot Numbers: 21A0506, 21C0501; i) B02317540Z, GTIN 03613720185598, Lot Numbers: 21A0110, 21A0508, 21A0524, 22B0782; j) B02317545Z, GTIN 03613720185628, Lot Numbers: 20E0097, 21A0076, 21B0498; k) B02317550Z, GTIN 03613720185659, Lot Numbers: 20C0294, 20H0508, 20J0283, 22B0366963 units
Z-2459-2023GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿ A13132012, g)¿¿¿¿¿ B13111014, h)¿¿¿¿ B13111015, i)¿¿¿¿¿¿ B13111016, j)¿¿¿¿¿¿ B13111017, k)¿¿¿¿¿ B13111025, l)¿¿¿¿¿¿ B13111026, m)¿¿¿ B13111027, n)¿¿¿¿ B13111034, o)¿¿¿¿ B13111035, p)¿¿¿¿ B13111036; intervertebral fusion device - cervical; a)¿¿¿¿¿ A13111427, GTIN 03613720235637, Lot Numbers: 19D0379, 19J0745, 20F0921; b)¿¿¿¿ A13112567, GTIN 03613720235651, Lot Numbers: 18F0191, 19D0380; c)¿¿¿¿¿ A13113456, GTIN 03613720235668. Lot Numbers: 19C0241, 20F0929; d)¿¿¿¿ A13131516, GTIN 03613720235682, Lot Numbers: 21A0438; e)¿¿¿¿ A13131789, GTIN 03613720235699, Lot Numbers: 21D0856; f)¿¿¿¿¿¿ A13132012, GTIN 03613720235705, Lot Numbers: 21D0857; g)¿¿¿¿¿ B13111014, GTIN 03613720192602, Lot Numbers: 18J0704, 19I0437, 19L0317, 20B0743, 20H0170, 20I0346; h)¿¿¿¿ B13111015, GTIN 03613720192619, Lot Numbers: 18A0891, 18L0331, 19B0305, 19D0744, 19G0689, 19I0840, 19K0222, 20A0967, 20B0167, 20I0201, 20J0513, 21A0098,; i)¿¿¿¿¿¿ B13111016, GTIN 03613720192626, Lot Numbers: 18J0705, 19C0759, 19I0435, 19L0103, 20G0353, 20K0398, 21A0099, 21A0574, 21F0151; j)¿¿¿¿¿¿ B13111017, GTIN 03613720192633, Lot Numbers: 18J0706, 21D0097, 21I0125; k)¿¿¿¿¿ B13111025, GTIN 03613720192664, Lot Numbers: 18D0593, 19A0658, 19C0394, 19K0343, 20J0514; l)¿¿¿¿¿¿ B13111026, GTIN 03613720192671, Lot Numbers: 18J0707, 20J0516, 21I0072; m)¿¿¿ B13111027, GTIN 03613720192688, Lot Numbers: 18J0709, 21A0575, 21I0126; n)¿¿¿¿ B13111034, GTIN 03613720192718, Lot Numbers: 18B1066, 18D0594, 18E0614, 18H0671, 18K0878, 18L0389, 19A0354, 19A0377, 19D0306, 19D0307, 19D0578, 19E0387, 19J0465, 19K0068, 19L0607, 20B0744, 20G0354, 20K0399, 21A0203, 21A0732, 21F0153; o)¿¿¿¿ B13111035, GTIN 03613720192725, Lot Numbers: 18A0892, 18J0465, 18J0710, 19A0355, 19B0304, 19B0394, 19B0395, 19D0579, 19F0100R, 19J0466, 19K0069, 19L0394, 20B0745, 20C0296, 20G0355, 20I0348, 20K0434, 21A0103; p)¿¿¿¿ B13111036, GTIN 03613720192732, Lot Numbers: 18B1067, 18F1031, 18J0466, 18J0711, 18L0390, 19A0356, 19B0915, 19D0581, 19G0690, 19K0157, 19L0804, 20E0256, 20I0349, 20J0512, 21A0104O (US)
Z-2460-2023IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical; a) B20240104, GTIN 03613720234241, Lot Numbers: 19A0773, 19B0524, 19C0511, 19E0477, 19K0180; b) B20240105, GTIN 03613720234258, Lot Numbers: 18K0653, 18L0497, 19A0636, 19A0654, 19B0189, 19C0512, 19C0664, 19I0849, 19L0701, 20G0851, 20H0262, 20I0570, 20I0877, 21D0764; c) B20240106, GTIN 03613720234265, Lot Numbers: 18C0676R, 18C0677, 18D0172, 19E0573, 19K0687, 20B0586, 20H0263, 20J0077, 21D0148, 21J0504, 22B0181; d) B20240107, GTIN 03613720234272, Lot Numbers: 18D0174, 18L0401, 18L0498, 19D0672, 19E0087, 19G1092, 19K0478, 20B0587, 20H0264, 21H0507, 22B0485; e) B20240205, GTIN 03613720234319, Lot Numbers: 22D0384, 22G0443; f) B20240206, GTIN 03613720234326, Lot Numbers: 20H0265, 22B0182; g) B20240207, GTIN 03613720234333, Lot Numbers: 18I0761, 18J0489, 19C0513, 20A0488, 20H0266; h) B20240208, GTIN 03613720234340, Lot Numbers: 18K0298, 19D0565, 19I0617, 20C0164, 20H0267, 22A07360 (US)
Z-2461-2023IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical; a) B15328071S, GTIN 03613720195535, Lot Numbers: 19I0696, 20A0759; b) B15328073S, GTIN 03613720195573, Lot Numbers: 20B0747; c) B15328074S, GTIN 03613720195597, Lot Numbers: 19I0698; d) B15334072S, GTIN 03613720195832, Lot Numbers: 19I0557, 20F0185; e) B15334073S, GTIN 03613720195856, Lot Numbers: 19J0947; f) B15334074S, GTIN 03613720195870, Lot Numbers: 19E0502, 19J0091, 20F01840 (US)
Z-2462-2023IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973, i) B20172253, j) B20172263, k) B20172273; intervertebral fusion device - cervical; a) B20171743, GTIN 03613720232636, Lot Numbers: 18E0275, 18E0404, 18E0676, 18E0833, 18I0867, 18K0143, 18L0219, 19A0463, 19A0669, 19B0870, 19D0484, 19G0192, 19G0422, 19J0468, 19L0381, 20F0631, 20G0849, 20H0596, 20H0597, 20H0598, 20I0875, 20J0772, 21I0163, 22A0172, 22D0807, 22E0264, 22G0048, 22G0477, 22I0342; b) B20171753, GTIN 03613720232667, Lot Numbers: 18H0597, 18K0137, 18K0831, 18L0488, 19A0324, 19A0325, 19B0362, 19B0470, 19D0485, 19E0322, 19G0204, 19G0423, 19I0274, 19J0273, 19L0382, 20F0632, 20F0633, 20H0600, 20H0601, 20H0602, 20H0603, 20I0222, 21C0104, 21F0651, 21I0511, 22I0615, 22J0265; c) B20171763, GTIN 03613720232698, Lot Numbers: 18E0405, 18E0834, 18G0422, 18H0572, 18J0063, 18K0066, 18L0070, 18L0489, 19A0215, 19A0425, 19B0687, 19C0653, 19D0486, 19E0436, 19G0830, 19I0842, 19L0383, 20F0634, 20H0594, 20H0595, 21E0234, 21G0482, 22I0343; d) B20171773, GTIN 03613720232728, Lot Numbers: 19C0591, 19F0579, 19H0089, 19J0272, 20F0635, 20H0249, 22G0571; e) B20171943, GTIN 03613720232841, Lot Numbers: 18C0552, 18E0835, 18I0712, 18K0897, 18L0490, 19A0670, 19B0680, 19D0251, 19G0302, 19I0582, 20A0644, 20F0636, 20H0599, 20I0487, 21H0101, 22A0173, 22B0482, 22D0808, 22E0808; f) B20171953, GTIN 03613720232872, Lot Numbers: 18E0483, 18E0677, 18E0836, 18J0103, 18K0144, 18L0400, 19A0159, 19A0671, 19A0675, 19B0089, 19D0487, 19D0637, 19F0103, 19G0303, 19H0375, 19I0843, 19K0586, 20A0200, 20C0163, 20F0637, 20H0251, 20H0254, 20H0255, 20J0062, 20J0065, 20J0368, 21F0551, 21I0177, 22B0786, 22E0263, 22E0809, 22F0490, 22F0492, 22G0440, 22H0055, 22J0202; g) B20171963, GTIN 03613720232902, Lot Numbers: 18K0158, 18L0491, 19A0672, 19A0829, 19C0146, 19D0262, 19E0437, 19G0424, 19H0376, 19I0234, 19K0832, 19L0613, 20A0969, 20F0638, 20H0604, 20H0605, 20H0606, 20H0607, 20I0705, 20J0068, 21F0155, 22D0809, 22G0441, 22H0643, 22J0203,; h) B20171973, GTIN 03613720232933, Lot Numbers: 18D0171, 18F0203, 18I0466, 18K0136, 18L0492, 19A0673, 19D0488, 19I0844, 20H0257, 21A0064, 22D0385, 22F1090, 22G0442; i) B20172253, GTIN 03613720233084, Lot Numbers: 18E0406, 18K0140, 18K0898, 19A0214, 19B0174, 19C0728, 19E0438, 19I0583, 20H0258, 20K0542, 21G0760; j) B20172263, GTIN 03613720233114, Lot Numbers: 18D1078, 18G0423, 18K0159, 18L0220, 19A0069, 19B0175, 19E0439, 19I0845, 20A0995, 20F0386, 20H0593, 20J0127, 21F0247, 21J0503; k) B20172273, GTIN 03613720233145, Lot Numbers: 18K0160, 18K0608, 19A0079, 19B0471, 19C0729, 19D0671, 19J0469, 20H0259, 22B0180, 22B0484, 22E0095N/A
Based on the official FDA remedy

What to do — step by step

  1. Check Product Reference

    Verify the reference number on your IMPIX S device to see if it matches the recalled list: B15328071S, B15328073S, B15328074S, B15334072S, B15334073S, or B15334074S.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 49 days after the firm started it.

1. Firm started the recall: Jul 12, 202312. FDA classified it Class II: Aug 24, 202323. Published in FDA’s Enforcement Report: Aug 30, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2461-2023 (July 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2461-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA