🔍 RecallPedia

Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Sterile; (3) Presource PBDS Cat. PODKHAKAB, Kit, Hip Arthroscopy, Sterile; (4) Presource PBDS, Cat. POMHKAESV, Kit, Knee Arthroscopy, SE, Sterile; (5) Presource PBDS Cat. POMHLEE11, Kit, Extremity, SE, Sterile; (6) Presource PBDS Cat. POMVTHANLE, Kit, Anterior Hip, Sterile; (7) Presource PBDS Cat. POVMPAB11, Kit, PAO Pack, Barnes Jewish, Sterile; (8) Presource PBDS Cat. PO08LXG21, Kit, Extremity, Grant, Sterile; (9) Presource PBDS Cat. PO11HRFH6, Kit, Anterior Hip, Sterile; (10) Presource PBDS Cat. PO11OTASS8, Kit, Trauma Hip A and B, Sterile; (11) Presource PBDS Cat. PO11OTSSP, Kit, Trauma Knee A and B, Sterile; (12) Presource PBDS Cat. PO11THAS13, Kit, Anterior Hip, Sterile; (13) Presource PBDS Cat. PO12AHSUQ, Kit, Anterior Hip, Sterile; (14) Presource PBDS Cat. PO12AHSU7, Kit, Anterior Hip, Sterile; (15) Presource PBDS, Cat. PO18AHEFG, Kit, Anterior Hip, Sterile; (16) Presource PBDS Cat. PO3LHPLM2, Kit, Hip Pinning, Sterile; (17) Presource PBDS Cat. PO3LHPLM3, Kit, Hip Pinning, Sterile; (18) Presource PBDS Cat. PO33AHCRA, Kit, Anterior Hip, Sterile; (19) Presource PBDS Cat. PO56MLGRA, Kit, MC Lower Extremity, Sterile; (20) Presource Spine Pack, Cat. SNECGSPAHB,Sterile; (21) Presource Spine Pack, Cat. SNECGSPAH4, Sterile; (22) Presource Ortho Laminectomy Pack, Cat. SNE12OL89A, Sterile; (23) Presource ACD Pack, Cat. SNE33ACCRD, Sterile; (24) Presource Anterior Fusion Pack, Cat. SNE33AFC18, Sterile; (25) Presource Lumbar Disk Pack, Cat. SNE33LMCAB, Sterile; (26) Presource SDMC Ortho Spine Accessory Pk, Cat. SNE73SAKSD, Sterile; (27) Presource Hip Arthroscopy Pack, Cat. SOPCNHAMSD, Sterile; (28) Presource Anterior Approach Total Hip Pk, Cat. SOPDKAHC12, Sterile; (29) Presource Physician Partner of America, Cat. SOPHFLSHAC, Sterile; (30) Presource MH Hip With Curtain Std Pack, Cat. SOPMHHCM10, Sterile; (31) Presource Back Pack, Cat. SOPOCBPLSD, Sterile; (32) Presource HFHS Ortho Spine Pack, Cat. SOPW1OSHFM, Sterile; (33) Presource PED Extremity Pack, Cat. SOP11PER12, Sterile; (34) Presource Hip Arthroscopy Pack, Cat. SOP12HAGTC, Sterile; (35) Presource OPSC Hip Arthroscopy Pack, Cat. SOP12HAUVE, Sterile; (36) Presource Major Ortho, Cat. SOP12MJHM6, Sterile; (37) Presource Pedi Ortho Spine W Basin Pack, Cat. SOP22PSMRE, Sterile; (38) Presource Lower Extremity Pack 302095, Cat. SOP3LLESGK, Sterile; (39) Presource ORIF Wrist Sturgeon Pack, Cat. SOP30ACSCG, Sterile; (40) Presource Ensemble Pied Cheville 3, Cat. SOP30AKJTF, Sterile; (41) Presource Fracture Pack, Cat. SOP30FRUHE, Sterile; (42) Presource Anterior Total Hip Pack, Cat. SOP30HALHB, Sterile; (43) Presource Hip Pack, Cat. SOP30HPWME, Sterile; (44) Presource Hip Scope Pack, Cat. SOP30HSCHE, Sterile; (45) Presource Ortho Split Pack, Cat. SOP30OSVI8, Sterile; (46) Presource Pack Trauma Uppr Extrmty Civic, Cat. SOP30UPOHD, Sterile; (47) Presource Anterior Hip Pack, Cat. SOP32AHGMH, Sterile; (48) Presource Anterior Tha Pack, Cat. SOP33ANOOI, Sterile; (49), Presource CPT Ortho Custom UH Pack, Cat. SOP33OROUJ, Sterile; (50) Presource CPT Ortho Custom UH Pack, Cat. SOP33OROU5, Sterile; (51) Presource Anterior Hip Pk, Cat. SOP35AHAMG, Sterile; (52) Presource Hip Pack, Cat. SOP41HISP6, Sterile; (53) Presource Spine Tray, Cat. SOP44STHPC, Sterile; (54) Presource Anterior Hip Pack, Cat. SOP5BAHHEE, Sterile; (55) Presource Essentia Anterior Hip Surgi Pk, Cat. SOP5BHSEHD, Sterile; (56) Presource CPT Ortho Custom James Pk, Cat. SOP5CCJOUH, Sterile; (57) Presource Back Part 1, Cat. SOP51BAKOF, Sterile; (58) Presource Back Part 1, Cat. SOP51BAKO9, Sterile; (59) Presource Pack Total Hip Anter Surg WMC, Cat. SOP53APKP4, Sterile; (60) Presource West Hip Anterior Total Pack, Cat. SOP56HAMT8, Sterile; (61) Presource Anterior Hip Pack, Cat. SOP57AHSH5, Sterile; (62) Presource Total Hip Pack, Cat. SOP6VTHPOA, Sterile; (63) Presource ASU Hip Arthroscopy Pack, Cat. S

Class I - Dangerous
🏥 Medical Devices Recalled: August 16, 2023 Cardinal Health 200 Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    (1) Cat. PN33BPCR2 - Lot #986971, Exp. 9/1/2024, UDI-DI 10197106132319; (2) Cat. POCGANA11 - Lot #936749, Exp. 8/1/2024, UDI-DI 10197106027257; (3) Cat. PODKHAKAB - Lot #18022, Exp. 5/1/2024, UDI-DI 10888439441819; (4) Cat. POMHKAESV - Lot #967651, Exp. 12/1/2023, UDI-DI 10195594543341; (5) Cat. POMHLEE11 - Lot #39223, Exp. 8/1/2024, UDI-DI 10197106255087; (6) Cat. POMVTHANLE - Lot #926669, Exp. 9/1/2023, UDI-DI 10195594471781; (7) Cat. POVMPAB11 - Lot #951430, Exp. 8/1/2024, UDI-DI 50197106054701; (8) Cat. PO08LXG21 - Lot #941775, Exp. 12/1/2024, UDI-DI 10197106032404; (9) Cat. PO11HRFH6 - Lot #921333, Exp. 5/1/2024, UDI-DI 10195594894191; (10) Cat. PO11OTASS8 - Lot #920211, Exp. 2/1/2024, UDI-DI 10195594888121; (11) Cat. PO11OTSSP - Lot #57290, Exp. 4/1/2024, UDI-DI 10197106108611; (12) Cat. PO11THAS13 - Lot #966763, Exp. 8/1/2024, UDI-DI 10197106087190; (13) Cat. PO12AHSUQ - Lot #930429, Exp. 1/1/2024, UDI-DI 10195594397760; (14) Cat. PO12AHSU7 - Lot #17680, Exp. 10/1/2024, UDI-DI 10197106201329; (15) Cat. PO18AHEFG - Lot #940003, Exp. 8/1/2024, UDI-DI 10888439910193; (16) Cat. PO3LHPLM2 - Lot #905668, Exp. 6/1/2025, UDI-DI 10195594828790; (17) Cat. PO3LHPLM3 - Lot #925611, Exp. 7/1/2025, UDI-DI 10197106000298; (18) Cat. PO33AHCRA - Lot #998611, Exp. 1/1/2025, UDI-DI 10195594899264; (19) Cat. PO56MLGRA - Lot #4327, Exp. 7/1/2025, UDI-DI 10197106115008; (20) Cat. SNECGSPAHB - Lot #986454, Exp. 9/1/2024, UDI-DI 10195594020798; (21) Cat. SNECGSPAH4 - Lot #40840, Exp. 9/1/2024, UDI-DI 10197106266328; (22) Cat. SNE12OL89A - Lot #18306, Exp. 12/1/2023 and 5/1/2024, UDI-DI 10195594527723; (23) Cat. SNE33ACCRD - Lot #931311, Exp. 6/1/2024, UDI-DI 10195594895839; (24) Cat. SNE33AFC18 - Lot #941894, Exp. 8/1/2024, UDI-DI 10197106033807; (25) Cat. SNE33LMCAB - Lot #922696, Exp. 8/1/2024 and Exp. 5/1/2024, UDI-DI 10195594472559; (26) Cat. SNE73SAKSD - Lot #920769, Exp. 8/1/2024, UDI-DI 10888439615173; (27) Cat. SOPCNHAMSD - Lot #969039, Exp. 9/1/2024 and Exp. 7/1/2024, UDI-DI 10888439903140; (28) Cat. SOPDKAHC12 - Lot #997357, Exp. 9/1/2024, UDI-DI 10197106163337; (29) Cat. SOPHFLSHAC - Lot #998464, Exp. 4/1/2027, UDI-DI 10888439912098; (30) Cat. SOPMHHCM10 - Lot #996397, Exp. 12/1/20025, UDI-DI 10197106163634; (31) Cat. SOPOCBPLSD - Lot #893040, Exp. 4/1/2024, UDI-DI 10888439909210; (32) Cat. SOPW1OSHFM - Lot #931594, Exp. 7/1/2024, UDI-DI 10888439936759; (33) Cat. SOP11PER12 - Lot #920426, Exp. 8/1/2023, UDI-DI 10195594880781; (34) Cat. SOP12HAGTC - Lot #986429, Exp. 1/1/2024, UDI-DI 10195594961923; (35) Cat. SOP12HAUVE - Lot #64393, Exp. 11/1/2024, UDI-DI 10197106300657; (36) Cat. SOP12MJHM6 - Lot #922502, Exp. 12/1/2023, UDI-DI 10195594892081; (37) Cat. SOP22PSMRE - Lot #928986, Exp. 6/1/2024, UDI-DI 10888439917376; (38) Cat. SOP3LLESGK - Lot #959551, Exp. 4/1/2025 and Exp. 5/1/2025, UDI-DI 10195594495930; (39) Cat. SOP30ACSCG - Lot #929766, Exp. 3/1/2027, UDI-DI 10195594759780; (40) Cat. SOP30AKJTF - Lot #16244, Exp. 11/1/2027, UDI-DI 10197106080160; (41) Cat. SOP30FRUHE - Lot #986684, Exp. 12/1/2024, UDI-DI 10195594614263; (42) Cat. SOP30HALHB - Lot #924124, Exp. 12/1/2025, UDI-DI 10195594737351; (43) Cat. SOP30HPWME - Lot #991876, Exp. 6/1/2024, UDI-DI 10888439936414; (44) Cat. SOP30HSCHE - Lot #12487, Exp. 12/1/2024, UDI-DI 10888439853025; (45) Cat. SOP30OSVI8 - Lot #921913, Exp. 6/1/2027, UDI-DI 10195594891343; (46) Cat. SOP30UPOHD - Lot #929776, Exp. 10/1/2026, UDI-DI 10195594469139; (47) Cat. SOP32AHGMH - Lot #71002, Exp. 1/1/2027, UDI-DI 10197106088661; (48) Cat. SOP33ANOOI - Lot #998668, Exp. 4/1/2024, UDI-DI 10197106026588; (49) Cat. SOP33OROUJ - Lot #930189, Exp. 6/1/2024 and Exp. 5/1/2024, UDI-DI 10195594700683; (50) Cat. SOP33OROU5 - Lot #918471, Exp. 2/1/2024, UDI-DI 10195594876340; (51) Cat. SOP35AHAMG - Lot #923516, Exp. 4/1/2024, UDI-DI 10195594571696, (52) Cat. SOP41HISP6 - Lot #916958, Exp. 2/1/2024, UDI-DI 10195594873691; (53) Cat. SOP44STHPC - Lot #12393, Exp. 12/1/2024, UDI-DI 10888439912180; (54) Cat. SOP5BAHHEE - Lot #53599, Exp. 12/1/2024, UDI-DI 10195594532246; (55) Cat. SOP5BHSEHD - Lot #986063, Exp. 10/1/2024, UDI-DI 10888439654790; (56) Cat. SOP5CCJOUH - Lot #920091, Exp. 7/1/2024, UDI-DI 10195594663902; (57) Cat. SOP51BAKOF - Lot #966211, Exp. 10/1/2024, UDI-DI 10887488579931; (58) Cat. SOP51BAKO9 - Lot #927573, Exp. 6/1/2024, UDI-DI 10197106005507; (59) Cat. SOP53APKP4 - Lot #929995, Exp. 2/1/2024, UDI-DI 10197106012741; (60) Cat. SOP56HAMT8 - Lot #920050, Exp. 10/1/2023, UDI-DI 10195594882600; (61) Cat. SOP57AHSH5 - Lot #986901, Exp. 12/1/2024, UDI-DI 10197106133361; (62) Cat. SOP6VTHPOA - Lot #986320, Exp. 10/1/2024, UDI-DI 10195594408312; (63) Cat. SOP69AHKCF - Lot #915225, Exp. 3/1/2024, UDI-DI 10887488576046; (64) Cat. SOP69AHKC2 - Lot #912556, Exp. 3/1/2024, UDI-DI 10195594862879; (65) Cat. SOP69AHMRI - Lot #4205, Exp. 8/1/2024, Exp. 12/1/2024, and Exp. 6/1/2024, UDI-DI 10195594097295; (66) Cat. SOP69SHWMR - Lot #913072, Exp. 3/1/2024, UDI-DI 10195594106331; (67) Cat. SOP69TAKT3 - Lot #922930, Exp. 6/1/2024, UDI-DI 10195594892852; (68) Cat. SOP69TAKT6 - Lot #986238, Exp. 10/1/2024, UDI-DI 10197106133132; (69) Cat. SOP69TSKBA - Lot #986066, Exp. 1/1/2024, UDI-DI 10195594464431; (70) Cat. SOP73HAKPH - Lot #942491, Exp. 7/1/2024, UDI-DI 10195594446345; (71) Cat. SOP73SPDOC - Lot #970296, Exp. 2/1/2024, UDI-DI 10888439930733; and (72) Cat. SOP82AHBFK - Lot #18539, Exp. 7/1/2023 and Exp. 12/1/2023, UDI-DI 10888439974881.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cardinal Health 200, LLC
Reason for Recall:
XXX
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Sterile; (3) Presource PBDS Cat. PODKHAKAB, Kit, Hip Arthroscopy, Sterile; (4) Presource PBDS, Cat. POMHKAESV, Kit, Knee Arthroscopy, SE, Sterile; (5) Presource PBDS Cat. POMHLEE11, Kit, Extremity, SE, Sterile; (6) Presource PBDS Cat. POMVTHANLE, Kit, Anterior Hip, Sterile; (7) Presource PBDS Cat. POVMPAB11, Kit, PAO Pack, Barnes Jewish, Sterile; (8) Presource PBDS Cat. PO08LXG21, Kit, Extremity, Grant, Sterile; (9) Presource PBDS Cat. PO11HRFH6, Kit, Anterior Hip, Sterile; (10) Presource PBDS Cat. PO11OTASS8, Kit, Trauma Hip A and B, Sterile; (11) Presource PBDS Cat. PO11OTSSP, Kit, Trauma Knee A and B, Sterile; (12) Presource PBDS Cat. PO11THAS13, Kit, Anterior Hip, Sterile; (13) Presource PBDS Cat. PO12AHSUQ, Kit, Anterior Hip, Sterile; (14) Presource PBDS Cat. PO12AHSU7, Kit, Anterior Hip, Sterile; (15) Presource PBDS, Cat. PO18AHEFG, Kit, Anterior Hip, Sterile; (16) Presource PBDS Cat. PO3LHPLM2, Kit, Hip Pinning, Sterile; (17) Presource PBDS Cat. PO3LHPLM3, Kit, Hip Pinning, Sterile; (18) Presource PBDS Cat. PO33AHCRA, Kit, Anterior Hip, Sterile; (19) Presource PBDS Cat. PO56MLGRA, Kit, MC Lower Extremity, Sterile; (20) Presource Spine Pack, Cat. SNECGSPAHB,Sterile; (21) Presource Spine Pack, Cat. SNECGSPAH4, Sterile; (22) Presource Ortho Laminectomy Pack, Cat. SNE12OL89A, Sterile; (23) Presource ACD Pack, Cat. SNE33ACCRD, Sterile; (24) Presource Anterior Fusion Pack, Cat. SNE33AFC18, Sterile; (25) Presource Lumbar Disk Pack, Cat. SNE33LMCAB, Sterile; (26) Presource SDMC Ortho Spine Accessory Pk, Cat. SNE73SAKSD, Sterile; (27) Presource Hip Arthroscopy Pack, Cat. SOPCNHAMSD, Sterile; (28) Presource Anterior Approach Total Hip Pk, Cat. SOPDKAHC12, Sterile; (29) Presource Physician Partner of America, Cat. SOPHFLSHAC, Sterile; (30) Presource MH Hip With Curtain Std Pack, Cat. SOPMHHCM10, Sterile; (31) Presource Back Pack, Cat. SOPOCBPLSD, Sterile; (32) Presource HFHS Ortho Spine Pack, Cat. SOPW1OSHFM, Sterile; (33) Presource PED Extremity Pack, Cat. SOP11PER12, Sterile; (34) Presource Hip Arthroscopy Pack, Cat. SOP12HAGTC, Sterile; (35) Presource OPSC Hip Arthroscopy Pack, Cat. SOP12HAUVE, Sterile; (36) Presource Major Ortho, Cat. SOP12MJHM6, Sterile; (37) Presource Pedi Ortho Spine W Basin Pack, Cat. SOP22PSMRE, Sterile; (38) Presource Lower Extremity Pack 302095, Cat. SOP3LLESGK, Sterile; (39) Presource ORIF Wrist Sturgeon Pack, Cat. SOP30ACSCG, Sterile; (40) Presource Ensemble Pied Cheville 3, Cat. SOP30AKJTF, Sterile; (41) Presource Fracture Pack, Cat. SOP30FRUHE, Sterile; (42) Presource Anterior Total Hip Pack, Cat. SOP30HALHB, Sterile; (43) Presource Hip Pack, Cat. SOP30HPWME, Sterile; (44) Presource Hip Scope Pack, Cat. SOP30HSCHE, Sterile; (45) Presource Ortho Split Pack, Cat. SOP30OSVI8, Sterile; (46) Presource Pack Trauma Uppr Extrmty Civic, Cat. SOP30UPOHD, Sterile; (47) Presource Anterior Hip Pack, Cat. SOP32AHGMH, Sterile; (48) Presource Anterior Tha Pack, Cat. SOP33ANOOI, Sterile; (49), Presource CPT Ortho Custom UH Pack, Cat. SOP33OROUJ, Sterile; (50) Presource CPT Ortho Custom UH Pack, Cat. SOP33OROU5, Sterile; (51) Presource Anterior Hip Pk, Cat. SOP35AHAMG, Sterile; (52) Presource Hip Pack, Cat. SOP41HISP6, Sterile; (53) Presource Spine Tray, Cat. SOP44STHPC, Sterile; (54) Presource Anterior Hip Pack, Cat. SOP5BAHHEE, Sterile; (55) Presource Essentia Anterior Hip Surgi Pk, Cat. SOP5BHSEHD, Sterile; (56) Presource CPT Ortho Custom James Pk, Cat. SOP5CCJOUH, Sterile; (57) Presource Back Part 1, Cat. SOP51BAKOF, Sterile; (58) Presource Back Part 1, Cat. SOP51BAKO9, Sterile; (59) Presource Pack Total Hip Anter Surg WMC, Cat. SOP53APKP4, Sterile; (60) Presource West Hip Anterior Total Pack, Cat. SOP56HAMT8, Sterile; (61) Presource Anterior Hip Pack, Cat. SOP57AHSH5, Sterile; (62) Presource Total Hip Pack, Cat. SOP6VTHPOA, Sterile; (63) Presource ASU Hip Arthroscopy Pack, Cat. S

Product Codes/Lot Numbers:

(1) Cat. PN33BPCR2 - Lot #986971, Exp. 9/1/2024, UDI-DI 10197106132319; (2) Cat. POCGANA11 - Lot #936749, Exp. 8/1/2024, UDI-DI 10197106027257; (3) Cat. PODKHAKAB - Lot #18022, Exp. 5/1/2024, UDI-DI 10888439441819; (4) Cat. POMHKAESV - Lot #967651, Exp. 12/1/2023, UDI-DI 10195594543341; (5) Cat. POMHLEE11 - Lot #39223, Exp. 8/1/2024, UDI-DI 10197106255087; (6) Cat. POMVTHANLE - Lot #926669, Exp. 9/1/2023, UDI-DI 10195594471781; (7) Cat. POVMPAB11 - Lot #951430, Exp. 8/1/2024, UDI-DI 50197106054701; (8) Cat. PO08LXG21 - Lot #941775, Exp. 12/1/2024, UDI-DI 10197106032404; (9) Cat. PO11HRFH6 - Lot #921333, Exp. 5/1/2024, UDI-DI 10195594894191; (10) Cat. PO11OTASS8 - Lot #920211, Exp. 2/1/2024, UDI-DI 10195594888121; (11) Cat. PO11OTSSP - Lot #57290, Exp. 4/1/2024, UDI-DI 10197106108611; (12) Cat. PO11THAS13 - Lot #966763, Exp. 8/1/2024, UDI-DI 10197106087190; (13) Cat. PO12AHSUQ - Lot #930429, Exp. 1/1/2024, UDI-DI 10195594397760; (14) Cat. PO12AHSU7 - Lot #17680, Exp. 10/1/2024, UDI-DI 10197106201329; (15) Cat. PO18AHEFG - Lot #940003, Exp. 8/1/2024, UDI-DI 10888439910193; (16) Cat. PO3LHPLM2 - Lot #905668, Exp. 6/1/2025, UDI-DI 10195594828790; (17) Cat. PO3LHPLM3 - Lot #925611, Exp. 7/1/2025, UDI-DI 10197106000298; (18) Cat. PO33AHCRA - Lot #998611, Exp. 1/1/2025, UDI-DI 10195594899264; (19) Cat. PO56MLGRA - Lot #4327, Exp. 7/1/2025, UDI-DI 10197106115008; (20) Cat. SNECGSPAHB - Lot #986454, Exp. 9/1/2024, UDI-DI 10195594020798; (21) Cat. SNECGSPAH4 - Lot #40840, Exp. 9/1/2024, UDI-DI 10197106266328; (22) Cat. SNE12OL89A - Lot #18306, Exp. 12/1/2023 and 5/1/2024, UDI-DI 10195594527723; (23) Cat. SNE33ACCRD - Lot #931311, Exp. 6/1/2024, UDI-DI 10195594895839; (24) Cat. SNE33AFC18 - Lot #941894, Exp. 8/1/2024, UDI-DI 10197106033807; (25) Cat. SNE33LMCAB - Lot #922696, Exp. 8/1/2024 and Exp. 5/1/2024, UDI-DI 10195594472559; (26) Cat. SNE73SAKSD - Lot #920769, Exp. 8/1/2024, UDI-DI 10888439615173; (27) Cat. SOPCNHAMSD - Lot #969039, Exp. 9/1/2024 and Exp. 7/1/2024, UDI-DI 10888439903140; (28) Cat. SOPDKAHC12 - Lot #997357, Exp. 9/1/2024, UDI-DI 10197106163337; (29) Cat. SOPHFLSHAC - Lot #998464, Exp. 4/1/2027, UDI-DI 10888439912098; (30) Cat. SOPMHHCM10 - Lot #996397, Exp. 12/1/20025, UDI-DI 10197106163634; (31) Cat. SOPOCBPLSD - Lot #893040, Exp. 4/1/2024, UDI-DI 10888439909210; (32) Cat. SOPW1OSHFM - Lot #931594, Exp. 7/1/2024, UDI-DI 10888439936759; (33) Cat. SOP11PER12 - Lot #920426, Exp. 8/1/2023, UDI-DI 10195594880781; (34) Cat. SOP12HAGTC - Lot #986429, Exp. 1/1/2024, UDI-DI 10195594961923; (35) Cat. SOP12HAUVE - Lot #64393, Exp. 11/1/2024, UDI-DI 10197106300657; (36) Cat. SOP12MJHM6 - Lot #922502, Exp. 12/1/2023, UDI-DI 10195594892081; (37) Cat. SOP22PSMRE - Lot #928986, Exp. 6/1/2024, UDI-DI 10888439917376; (38) Cat. SOP3LLESGK - Lot #959551, Exp. 4/1/2025 and Exp. 5/1/2025, UDI-DI 10195594495930; (39) Cat. SOP30ACSCG - Lot #929766, Exp. 3/1/2027, UDI-DI 10195594759780; (40) Cat. SOP30AKJTF - Lot #16244, Exp. 11/1/2027, UDI-DI 10197106080160; (41) Cat. SOP30FRUHE - Lot #986684, Exp. 12/1/2024, UDI-DI 10195594614263; (42) Cat. SOP30HALHB - Lot #924124, Exp. 12/1/2025, UDI-DI 10195594737351; (43) Cat. SOP30HPWME - Lot #991876, Exp. 6/1/2024, UDI-DI 10888439936414; (44) Cat. SOP30HSCHE - Lot #12487, Exp. 12/1/2024, UDI-DI 10888439853025; (45) Cat. SOP30OSVI8 - Lot #921913, Exp. 6/1/2027, UDI-DI 10195594891343; (46) Cat. SOP30UPOHD - Lot #929776, Exp. 10/1/2026, UDI-DI 10195594469139; (47) Cat. SOP32AHGMH - Lot #71002, Exp. 1/1/2027, UDI-DI 10197106088661; (48) Cat. SOP33ANOOI - Lot #998668, Exp. 4/1/2024, UDI-DI 10197106026588; (49) Cat. SOP33OROUJ - Lot #930189, Exp. 6/1/2024 and Exp. 5/1/2024, UDI-DI 10195594700683; (50) Cat. SOP33OROU5 - Lot #918471, Exp. 2/1/2024, UDI-DI 10195594876340; (51) Cat. SOP35AHAMG - Lot #923516, Exp. 4/1/2024, UDI-DI 10195594571696, (52) Cat. SOP41HISP6 - Lot #916958, Exp. 2/1/2024, UDI-DI 10195594873691; (53) Cat. SOP44STHPC - Lot #12393, Exp. 12/1/2024, UDI-DI 10888439912180; (54) Cat. SOP5BAHHEE - Lot #53599, Exp. 12/1/2024, UDI-DI 10195594532246; (55) Cat. SOP5BHSEHD - Lot #986063, Exp. 10/1/2024, UDI-DI 10888439654790; (56) Cat. SOP5CCJOUH - Lot #920091, Exp. 7/1/2024, UDI-DI 10195594663902; (57) Cat. SOP51BAKOF - Lot #966211, Exp. 10/1/2024, UDI-DI 10887488579931; (58) Cat. SOP51BAKO9 - Lot #927573, Exp. 6/1/2024, UDI-DI 10197106005507; (59) Cat. SOP53APKP4 - Lot #929995, Exp. 2/1/2024, UDI-DI 10197106012741; (60) Cat. SOP56HAMT8 - Lot #920050, Exp. 10/1/2023, UDI-DI 10195594882600; (61) Cat. SOP57AHSH5 - Lot #986901, Exp. 12/1/2024, UDI-DI 10197106133361; (62) Cat. SOP6VTHPOA - Lot #986320, Exp. 10/1/2024, UDI-DI 10195594408312; (63) Cat. SOP69AHKCF - Lot #915225, Exp. 3/1/2024, UDI-DI 10887488576046; (64) Cat. SOP69AHKC2 - Lot #912556, Exp. 3/1/2024, UDI-DI 10195594862879; (65) Cat. SOP69AHMRI - Lot #4205, Exp. 8/1/2024, Exp. 12/1/2024, and Exp. 6/1/2024, UDI-DI 10195594097295; (66) Cat. SOP69SHWMR - Lot #913072, Exp. 3/1/2024, UDI-DI 10195594106331; (67) Cat. SOP69TAKT3 - Lot #922930, Exp. 6/1/2024, UDI-DI 10195594892852; (68) Cat. SOP69TAKT6 - Lot #986238, Exp. 10/1/2024, UDI-DI 10197106133132; (69) Cat. SOP69TSKBA - Lot #986066, Exp. 1/1/2024, UDI-DI 10195594464431; (70) Cat. SOP73HAKPH - Lot #942491, Exp. 7/1/2024, UDI-DI 10195594446345; (71) Cat. SOP73SPDOC - Lot #970296, Exp. 2/1/2024, UDI-DI 10888439930733; and (72) Cat. SOP82AHBFK - Lot #18539, Exp. 7/1/2023 and Exp. 12/1/2023, UDI-DI 10888439974881.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0091-2024

Related Recalls

Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL

Cardinal Health 200

Class I - Dangerous

The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.

Dec 26, 2025 Other Medical Devices Nationwide View Details →

ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503T ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Non-sterile; CT5504T ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Non-sterile; CT5505T ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Non-sterile; DP5001GT ChemoPlus Full Coverage Gown, Open Back, Large, medium Blue, Non- sterile; DP5002GT ChemoPlus Full Coverage Gown, Open Back, Extra Large, medium Blue, Non-sterile; DP5003GT ChemoPlus Full Coverage Gown, Open Back, Medium, medium Blue, Non-sterile; DP5004GT ChemoPlus Full Coverage Gown, Open Back, Extra Extra Large, medium Blue, Non-sterile; CT5500TS ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Sterile; CT5502TS ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503TS ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Sterile; CT5504TS ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Sterile; CT5505TS ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Sterile;

Cardinal Health 200

Class I - Dangerous

Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.

Nov 12, 2025 Infusion Pumps Nationwide View Details →