Class II FDA device recall · Z-2137-2023

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.

MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TOTAL HIP-LF, Model Number DYNJ24526P; f) TOTAL KNEE ARTHROPLASTY PACK, Model Number DYNJ26425L; g) TOTAL KNEE PACK 319735, Model Number DYNJ44635I; h) HIP ARTHROPLASTY PACK, Model Number DYNJ50072F; i) LEXINGTON TOTAL JOINT PACK, Model Number DYNJ55655L; j) TOTAL JOINT, Model Number DYNJ57827D; k) ANTERIOR HIP PACK, Model Number DYNJ59126B; l) TOTAL HIP PACK, Model Number DYNJ60918A; m) MAIN TOTAL JOINT, Model Number DYNJ61376C; n) TOTAL HIP PACK, Model Number DYNJ63383; o) ANTERIOR PACK, Model Number DYNJ64814A; p) TOTAL JOINT PACK, Model Number DYNJ64951; q) TOTAL KNEE PACK-EOSC, Model Number DYNJ65093B; r) TOTAL KNEE PACK-CSC, Model Number DYNJ65108F; s) MERCY ANTERIOR HIP, Model Number DYNJ66913A; t) TOTAL PACK, Model Number DYNJ68468C; u) TOTAL KNEE-LF, Model Number DYNJ69153F; v) TOTAL JOINT PACK, Model Number DYNJ80372B; w) ANTERIOR HIP PACK, Model Number DYNJ82038; x) HIP PACK, Model Number DYNJ82345A; y) TOTAL HIP PACK, Model Number DYNJ82627A; z) TOTAL KNEE PACK LEXINGTON CLIN, Model Number DYNJ83553; aa) TOTAL JOINT PACK, Model Number DYNJ83567A; bb) TOTAL KNEE ACCESSORY PACK, Model Number DYNJ83885; cc) HIP PACK, Model Number DYNJ84051; dd) TOTAL KNEE PACK, Model Number DYNJ84054; ee) OISC HAND KORCEK, Model Number DYNJ902351F; ff) TOTAL HIP, Model Number DYNJ903149D; gg) OISC TOTAL HIP BOTTROS, Model Number DYNJ904154O; hh) TOTAL HIP, Model Number DYNJ904331I; ii) TOTAL KNEE, Model Number DYNJ904332J; jj) CRANIOTOMY, Model Number DYNJ905330B; kk) TRAUMA-RAMA, Model Number DYNJ905886G; ll) ANTERIOR HIP, Model Number DYNJ907831D; mm) TOTAL HIP-LF, Model Number DYNJ908127B; nn) TOTAL KNEE-LF, Model Number DYNJ908128B; oo) TOTAL HIP CDS, Model Number DYNJ908331A; pp) TOTAL KNEE THEDA, Model Number DYNJ908683A; qq) TOTAL HIP-LF, Model Number DYNJ909000; rr) TOTAL KNEE-LF, Model Number DYNJ909002; ss) TOTAL HIP, Model Number DYNJ909198A; tt) HIP MOFFIT PPS-LF, Model Number DYNJ9428703Q; uu) LOWER EXTREMITY PPS-LF, Model Number DYNJ9428745R; vv) UPPER EXTREMITY SHOULDER PPS, Model Number DYNJ9428787O

Why it was recalled

Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".

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

a) Model Number CDS985555S, UDI/DI (EA) 10195327343798, UDI/DI (CS) 40195327343799; Lot Numbers:  23EBK088;  b) Model Number CDS985566Q, UDI/DI (EA) 10195327074418, UDI/DI (CS) 40195327074419; Lot Numbers:  23EBT802;  c) Model Number DYNJ0949139I, UDI/DI (EA) 10195327195366, UDI/DI (CS) 40195327195367; Lot Numbers:  23DBP964, 23CBU228;  d) Model Number DYNJ24525K, UDI/DI (EA) 10195327135751, UDI/DI (CS) 40195327135752; Lot Numbers:  23EBT909, 23EBG098, 23DBB838;  e) Model Number DYNJ24526P, UDI/DI (EA) 10195327135744, UDI/DI (CS) 40195327135745; Lot Numbers:  23EBU894;  f) Model Number DYNJ26425L, UDI/DI (EA) 10195327156985, UDI/DI (CS) 40195327156986; Lot Numbers:  23EDC133;  g) Model Number DYNJ44635I, UDI/DI (EA) 10193489958553, UDI/DI (CS) 40193489958554; Lot Numbers:  23EBX487;  h) Model Number DYNJ50072F, UDI/DI (EA) 10193489340921, UDI/DI (CS) 40193489340922; Lot Numbers:  23EMB984;   i) Model Number DYNJ55655L, UDI/DI (EA) 10195327102029, UDI/DI (CS) 40195327102020; Lot Numbers:  23EBU158, 23DBF885;  j) Model Number DYNJ57827D, UDI/DI (EA) 10193489910636, UDI/DI (CS) 40193489920637; Lot Numbers:  23EBG175, 23DBH412;  k) Model Number DYNJ59126B, UDI/DI (EA) 10193489395983, UDI/DI (CS) 40193489395984; Lot Numbers:  23EME586, 23DME845;  l) Model Number DYNJ60918A, UDI/DI (EA) 10193489257946, UDI/DI (CS) 40193489257947; Lot Numbers:  23EBR893;  m) Model Number DYNJ61376C, UDI/DI (EA) 10195327295066, UDI/DI (CS) 40195327295067; Lot Numbers:  23DMF789, 23CMD239;  n) Model Number DYNJ63383, UDI/DI (EA) 10193489735109, UDI/DI (CS) 40193489735100; Lot Numbers:  23EBM476;  o) Model Number DYNJ64814A, UDI/DI (EA) 10195327112806, UDI/DI (CS) 40195327112807; Lot Numbers:  23EBU903;  p) Model Number DYNJ64951, UDI/DI (EA) 10193489236224, UDI/DI (CS) 40193489236225; Lot Numbers:  23EBV507, 23DBO770;  q) Model Number DYNJ65093B, UDI/DI (EA) 10195327177508, UDI/DI (CS) 40195327177509; Lot Numbers:  23DBR961;  r) Model Number DYNJ65108F, UDI/DI (EA) 10195327256241, UDI/DI (CS) 40195327256242; Lot Numbers:  23DBR962;  s) Model Number DYNJ66913A, UDI/DI (EA) 10193489996234, UDI/DI (CS) 40193489996235; Lot Numbers:  23CBH897;  t) Model Number DYNJ68468C, UDI/DI (EA) 10195327097370, UDI/DI (CS) 40195327097371; Lot Numbers:  23EDA972, 23EDA325;  u) Model Number DYNJ69153F, UDI/DI (EA) 10195327332679, UDI/DI (CS) 40195327332670; Lot Numbers:  23EBJ155, 23DBK433;  v) Model Number DYNJ80372B, UDI/DI (EA) 10195327244156, UDI/DI (CS) 40195327244157; Lot Numbers:  23CBW640;  w) Model Number DYNJ82038, UDI/DI (EA) 10195327163372, UDI/DI (CS) 40195327163373; Lot Numbers:  23EME192, 23DMA865;  x) Model Number DYNJ82345A, UDI/DI (EA) 10195327216556, UDI/DI (CS) 40195327316557; Lot Numbers:  23CBV824;  y) Model Number DYNJ82627A, UDI/DI (EA) 10195327333331, UDI/DI (CS) 40195327333332; Lot Numbers:  23EBO198;  z) Model Number DYNJ83553, UDI/DI (EA) 10195327279356, UDI/DI (CS) 40195327279357; Lot Numbers:  23BBD673;  aa) Model Number DYNJ83567A, UDI/DI (EA) 10195327343033, UDI/DI (CS) 40195327343034; Lot Numbers:  23EBT837, 23DBS196;  bb) Model Number DYNJ83885, UDI/DI (EA) 10195327312237, UDI/DI (CS) 40195327312238; Lot Numbers:  23EBV315, 23CBR138;  cc) Model Number DYNJ84051, UDI/DI (EA) 10195327330316, UDI/DI (CS) 40195327330317; Lot Numbers:  23DBF769;  dd) Model Number DYNJ84054, UDI/DI (EA) 10195327330347, UDI/DI (CS) 40195327330348; Lot Numbers:  23DBF770;  ee) Model Number DYNJ902351F, UDI/DI (EA) 10195327318420, UDI/DI (CS) 40195327318421; Lot Numbers:  23EDA478;  ff) Model Number DYNJ903149D, UDI/DI (EA) 10195327271139, UDI/DI (CS) 40195327261130; Lot Numbers:  23EMF499;  gg) Model Number DYNJ904154O, UDI/DI (EA) 10195327318604, UDI/DI (CS) 40195327318605; Lot Numbers:  23EDB706, 23EDB571, 23EDA974;   hh) Model Number DYNJ904331I, UDI/DI (EA) 10195327025700, UDI/DI (CS) 40195327025701; Lot Numbers:  23EBG661, 23DBM833;  ii) Model Number DYNJ904332J, UDI/DI (EA) 10195327025694, UDI/DI (CS) 40195327025695; Lot Numbers:  23DBE789, 23DBD483;   jj) Model Number DYNJ905330B, UDI/DI (EA) 10193489781502, UDI/DI (CS) 40193489781503; Lot Numbers:  23DBO191;  kk) Model Number DYNJ905886G, UDI/DI (EA) 10195327329167, UDI/DI (CS) 40195327329168; Lot Numbers:  23EMI010, 23EMB432, 23CMH862;   ll) Model Number DYNJ907831D, UDI/DI (EA) 10195327239701, UDI/DI (CS) 40195327239702; Lot Numbers:  23EBP718, 23EBL801, 23EBD901, 23DBK483;  mm) Model Number DYNJ908127B, UDI/DI (EA) 10195327349929, UDI/DI (CS) 40195327349920; Lot Numbers:  23EBG158, 23DBP414;  nn) Model Number DYNJ908128B, UDI/DI (EA) 10195327349912, UDI/DI (CS) 40195327349913; Lot Numbers:  23DBN415;  oo) Model Number DYNJ908331A, UDI/DI (EA) 10195327190156, UDI/DI (CS) 40195327190157; Lot Numbers:  23EBP436, 23EBD808, 23DBK651;  pp) Model Number DYNJ908683A, UDI/DI (EA) 10195327251772, UDI/DI (CS) 40195327251773; Lot Numbers:  23DDC201;  qq) Model Number DYNJ909000, UDI/DI (EA) 10195327238100, UDI/DI (CS) 40195327238101; Lot Numbers:  23EBU113, 23EBE042, 23CBM408, 23BBR583;  rr) Model Number DYNJ909002, UDI/DI (EA) 10195327238148, UDI/DI (CS) 40195327238149; Lot Numbers:  23EBT351, 23EBI750;  ss) Model Number DYNJ909198A, UDI/DI (EA) 10195327414788, UDI/DI (CS) 40195327414789; Lot Numbers:  23FLA027;  tt) Model Number DYNJ9428703Q, UDI/DI (EA) 10195327329174, UDI/DI (CS) 40195327329175; Lot Numbers:  23CMF816;  uu) Model Number DYNJ9428745R, UDI/DI (EA) 10195327258368, UDI/DI (CS) 40195327258369; Lot Numbers:  23DMG164;  vv) Model Number DYNJ9428787O, UDI/DI (EA) 10195327328795, UDI/DI (CS) 40195327328795; Lot Numbers:  23DME833, 23CMG975

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution - US Nationwide and the country of Panama.

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-2137-2023
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: N/A
Origin: Northfield, IL
Recall initiated: 2023-05-18

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-2137-2023 · Source: openFDA enforcement.