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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92486

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 18, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A

Z-2131-2023
Recall number
Z-2131-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
183240 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

GTIN 10889942851850, Batch Numbers: 2023011090, 2023011190, 2023011790, 2023012090, 2023012590, 2023020790, 2023022390, 2023022490

Distribution pattern

Worldwide distribution - US Nationwide and the country of Panama.

device · product 2 of 7

MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O

Z-2132-2023
Recall number
Z-2132-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
15 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

UDI/DI (EA) 10195327303969, UDI/DI (CS) 40195327303960; Lot Numbers: 23EBE453, 23CBW365

Distribution pattern

Worldwide distribution - US Nationwide and the country of Panama.

device · product 3 of 7

MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A

Z-2133-2023
Recall number
Z-2133-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
144 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

UDI/DI (EA) 10159327251772, UDI/DI (CS) 40195327251773; Lot Numbers: 23DDA761

Distribution pattern

Worldwide distribution - US Nationwide and the country of Panama.

device · product 4 of 7

MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L

Z-2134-2023
Recall number
Z-2134-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
128 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

UDI/DI (EA) (01)10195327286057, UDI/DI(CS) (01)40195327286058; Lot Numbers: 23EDA775, 23CDB962

Distribution pattern

Worldwide distribution - US Nationwide and the country of Panama.

device · product 5 of 7

MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A

Z-2135-2023
Recall number
Z-2135-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
60 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

UDI/DI (EA) (01)10193489799477, UDI/DI (01)40193489799478; Lot Numbers: 23CBS268

Distribution pattern

Worldwide distribution - US Nationwide and the country of Panama.

device · product 6 of 7

MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB

Z-2136-2023
Recall number
Z-2136-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
1500 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

a) Model Number DYNJ64572A, UDI/DI (EA) 10195327112554, (CS) 40195327112555, Lot Numbers:23FBA458, 23DBC239 ; b) Model Number VAL050EEPKB, UDI/DI (EA) 10195327267149, (CS) 40195327267149, Lot Numbers: 23EBA381, 23CBI693, 23BBE528

Distribution pattern

Worldwide distribution - US Nationwide and the country of Panama.

device · product 7 of 7

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

Z-2137-2023
Recall number
Z-2137-2023
Initiated
May 18, 2023
Classification
Class II
Status
Ongoing
Quantity
4500 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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

Distribution pattern

Worldwide distribution - US Nationwide and the country of Panama.