Class II FDA device recall · Z-0091-2024

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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

Why it was recalled

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Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

(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.

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.

Recall record

Recalling firm: Cardinal Health 200, LLC
Product type: Devices
Recall number: Z-0091-2024
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Waukegan, IL
Recall initiated: 2023-08-16

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-0091-2024 · Source: openFDA enforcement.