CLASS II ONGOING Device recall · Reported 26 Jul 2023 · FDA Enforcement Report

Medline Probe Cover Kits containing sterile Ultrasound Gel recalled

MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a), distributed nationwide in the US. The recall was initiated on 18 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) Model Number CDS985555S, UDI/DI (EA) 10195327343798, UDI/DI (CS) 40195327343799; b) Model Number CDS985566Q, UDI/DI (EA) 10195327074418, UDI/DI (CS) 40195327074419; c) Model Number DYNJ0949139I, UDI/DI (EA) 10195327195366, UDI/DI (CS) 40195327195367; d) Model Number DYNJ24525K, UDI/DI (EA) 10195327135751, UDI/DI (CS) 40195327135752; e) Model Number DYNJ24526P, UDI/DI (EA) 10195327135744, UDI/DI (CS) 40195327135745; f) Model Number DYNJ26425L, UDI/DI (EA) 10195327156985, UDI/DI (CS) 40195327156986; g) Model Number DYNJ44635I, UDI/DI (EA) 10193489958553, UDI/DI (CS) 40193489958554; h) Model Number DYNJ50072F, UDI/DI (EA) 10193489340921, UDI/DI (CS) 40193489340922; i) Model Number DYNJ55655L, UDI/DI (EA) 10195327102029, UDI/DI (CS) 40195327102020; j) Model Number DYNJ57827D, UDI/DI (EA) 10193489910636, UDI/DI (CS) 40193489920637; k) Model Number DYNJ59126B, UDI/DI (EA) 10193489395983, UDI/DI (CS) 40193489395984; l) Model Number DYNJ60918A, UDI/DI (EA) 10193489257946, UDI/DI (CS) 40193489257947; m) Model Number DYNJ61376C, UDI/DI (EA) 10195327295066, UDI/DI (CS) 40195327295067; n) Model Number DYNJ63383, UDI/DI (EA) 10193489735109, UDI/DI (CS) 40193489735100; o) Model Number DYNJ64814A, UDI/DI (EA) 10195327112806, UDI/DI (CS) 40195327112807; p) Model Number DYNJ64951, UDI/DI (EA) 10193489236224, UDI/DI (CS) 40193489236225; q) Model Number DYNJ65093B, UDI/DI (EA) 10195327177508, UDI/DI (CS) 40195327177509; r) Model Number DYNJ65108F, UDI/DI (EA) 10195327256241, UDI/DI (CS) 40195327256242; s) Model Number DYNJ66913A, UDI/DI (EA) 10193489996234, UDI/DI (CS) 40193489996235; t) Model Number DYNJ68468C, UDI/DI (EA) 10195327097370, UDI/DI (CS) 40195327097371; u) Model Number DYNJ69153F, UDI/DI (EA) 10195327332679, UDI/DI (CS) 40195327332670; v) Model Number DYNJ80372B, UDI/DI (EA) 10195327244156, UDI/DI (CS) 40195327244157; w) Model Number DYNJ82038, UDI/DI (EA) 10195327163372, UDI/DI (CS) 40195327163373; x) Model Number DYNJ82345A, UDI/DI (EA) 10195327216556, UDI/DI (CS) 40195327316557; y) Model Number DYNJ82627A, UDI/DI (EA) 10195327333331, UDI/DI (CS) 40195327333332; z) Model Number DYNJ83553, UDI/DI (EA) 10195327279356, UDI/DI (CS) 40195327279357; aa) Model Number DYNJ83567A, UDI/DI (EA) 10195327343033, UDI/DI (CS) 40195327343034; bb) Model Number DYNJ83885, UDI/DI (EA) 10195327312237, UDI/DI (CS) 40195327312238; cc) Model Number DYNJ84051, UDI/DI (EA) 10195327330316, UDI/DI (CS) 40195327330317; dd) Model Number DYNJ84054, UDI/DI (EA) 10195327330347, UDI/DI (CS) 40195327330348; ee) Model Number DYNJ902351F, UDI/DI (EA) 10195327318420, UDI/DI (CS) 40195327318421; ff) Model Number DYNJ903149D, UDI/DI (EA) 10195327271139, UDI/DI (CS) 40195327261130; gg) Model Number DYNJ904154O, UDI/DI (EA) 10195327318604, UDI/DI (CS) 40195327318605; hh) Model Number DYNJ904331I, UDI/DI (EA) 10195327025700, UDI/DI (CS) 40195327025701; ii) Model Number DYNJ904332J, UDI/DI (EA) 10195327025694, UDI/DI (CS) 40195327025695; jj) Model Number DYNJ905330B, UDI/DI (EA) 10193489781502, UDI/DI (CS) 40193489781503; kk) Model Number DYNJ905886G, UDI/DI (EA) 10195327329167, UDI/DI (CS) 40195327329168; ll) Model Number DYNJ907831D, UDI/DI (EA) 10195327239701, UDI/DI (CS) 40195327239702; mm) Model Number DYNJ908127B, UDI/DI (EA) 10195327349929, UDI/DI (CS) 40195327349920; nn) Model Number DYNJ908128B, UDI/DI (EA) 10195327349912, UDI/DI (CS) 40195327349913; oo) Model Number DYNJ908331A, UDI/DI (EA) 10195327190156, UDI/DI (CS) 40195327190157; pp) Model Number DYNJ908683A, UDI/DI (EA) 10195327251772, UDI/DI (CS) 40195327251773; qq) Model Number DYNJ909000, UDI/DI (EA) 10195327238100, UDI/DI (CS) 40195327238101; rr) Model Number DYNJ909002, UDI/DI (EA) 10195327238148, UDI/DI (CS) 40195327238149; ss) Model Number DYNJ909198A, UDI/DI (EA) 10195327414788, UDI/DI (CS) 40195327414789; tt) Model Number DYNJ9428703Q, UDI/DI (EA) 10195327329174, UDI/DI (CS) 40195327329175; uu) Model Number DYNJ9428745R, UDI/DI (EA) 10195327258368, UDI/DI (CS) 40195327258369; vv) Model Number DYNJ9428787O, UDI/DI (EA) 10195327328795, UDI/DI (CS) 40195327328795; All lots within expiry, distributed from Medline between December 2017 - May 2023:

Quantity recalled4500 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2205-2023
FDA event ID: 92466
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 18 May 2023
FDA classified: 20 Jul 2023
Reported: 26 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Hip & Knee Implants

Timeline

18 May 2023	Recall initiated by company
20 Jul 2023	Classified by FDA	+63 days
26 Jul 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: 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

Where it was distributed

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

Nationwide

Stores named: Walmart

Questions about this recall

Is Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) on 18 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-2205-2023.

Why was it recalled?

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Which lots are affected?

a) Model Number CDS985555S, UDI/DI (EA) 10195327343798, UDI/DI (CS) 40195327343799; b) Model Number CDS985566Q, UDI/DI (EA) 10195327074418, UDI/DI (CS) 40195327074419; c) Model Number DYNJ0949139I, UDI/DI (EA) 10195327195366, UDI/DI (CS) 40195327195367; d) Model Number DYNJ24525K, UDI/DI (EA) 10195327135751, UDI/DI (CS) 40195327135752; e) Model Number DYNJ24526P, UDI/DI (EA) 10195327135744, UDI/DI (CS) 40195327135745; f) Model Number DYNJ26425L, UDI/DI (EA) 10195327156985, UDI/DI (CS) 40195327156986; g) Model Number DYNJ44635I, UDI/DI (EA) 10193489958553, UDI/DI (CS) 40193489958554; h) Model Number DYNJ50072F, UDI/DI (EA) 10193489340921, UDI/DI (CS) 40193489340922; i) Model Number DYNJ55655L, UDI/DI (EA) 10195327102029, UDI/DI (CS) 40195327102020; j) Model Number DYNJ57827D, UDI/DI (EA) 10193489910636, UDI/DI (CS) 40193489920637; k) Model Number DYNJ59126B, UDI/DI (EA) 10193489395983, UDI/DI (CS) 40193489395984; l) Model Number DYNJ60918A, UDI/DI (EA) 10193489257946, UDI/DI (CS) 40193489257947; m) Model Number DYNJ61376C, UDI/DI (EA) 10195327295066, UDI/DI (CS) 40195327295067; n) Model Number DYNJ63383, UDI/DI (EA) 10193489735109, UDI/DI (CS) 40193489735100; o) Model Number DYNJ64814A, UDI/DI (EA) 10195327112806, UDI/DI (CS) 40195327112807; p) Model Number DYNJ64951, UDI/DI (EA) 10193489236224, UDI/DI (CS) 40193489236225; q) Model Number DYNJ65093B, UDI/DI (EA) 10195327177508, UDI/DI (CS) 40195327177509; r) Model Number DYNJ65108F, UDI/DI (EA) 10195327256241, UDI/DI (CS) 40195327256242; s) Model Number DYNJ66913A, UDI/DI (EA) 10193489996234, UDI/DI (CS) 40193489996235; t) Model Number DYNJ68468C, UDI/DI (EA) 10195327097370, UDI/DI (CS) 40195327097371; u) Model Number DYNJ69153F, UDI/DI (EA) 10195327332679, UDI/DI (CS) 40195327332670; v) Model Number DYNJ80372B, UDI/DI (EA) 10195327244156, UDI/DI (CS) 40195327244157; w) Model Number DYNJ82038, UDI/DI (EA) 10195327163372, UDI/DI (CS) 40195327163373; x) Model Number DYNJ82345A, UDI/DI (EA) 10195327216556, UDI/DI (CS) 40195327316557; y) Model Number DYNJ82627A, UDI/DI (EA) 10195327333331, UDI/DI (CS) 40195327333332; z) Model Number DYNJ83553, UDI/DI (EA) 10195327279356, UDI/DI (CS) 40195327279357; aa) Model Number DYNJ83567A, UDI/DI (EA) 10195327343033, UDI/DI (CS) 40195327343034; bb) Model Number DYNJ83885, UDI/DI (EA) 10195327312237, UDI/DI (CS) 40195327312238; cc) Model Number DYNJ84051, UDI/DI (EA) 10195327330316, UDI/DI (CS) 40195327330317; dd) Model Number DYNJ84054, UDI/DI (EA) 10195327330347, UDI/DI (CS) 40195327330348; ee) Model Number DYNJ902351F, UDI/DI (EA) 10195327318420, UDI/DI (CS) 40195327318421; ff) Model Number DYNJ903149D, UDI/DI (EA) 10195327271139, UDI/DI (CS) 40195327261130; gg) Model Number DYNJ904154O, UDI/DI (EA) 10195327318604, UDI/DI (CS) 40195327318605; hh) Model Number DYNJ904331I, UDI/DI (EA) 10195327025700, UDI/DI (CS) 40195327025701; ii) Model Number DYNJ904332J, UDI/DI (EA) 10195327025694, UDI/DI (CS) 40195327025695; jj) Model Number DYNJ905330B, UDI/DI (EA) 10193489781502, UDI/DI (CS) 40193489781503; kk) Model Number DYNJ905886G, UDI/DI (EA) 10195327329167, UDI/DI (CS) 40195327329168; ll) Model Number DYNJ907831D, UDI/DI (EA) 10195327239701, UDI/DI (CS) 40195327239702; mm) Model Number DYNJ908127B, UDI/DI (EA) 10195327349929, UDI/DI (CS) 40195327349920; nn) Model Number DYNJ908128B, UDI/DI (EA) 10195327349912, UDI/DI (CS) 40195327349913; oo) Model Number DYNJ908331A, UDI/DI (EA) 10195327190156, UDI/DI (CS) 40195327190157; pp) Model Number DYNJ908683A, UDI/DI (EA) 10195327251772, UDI/DI (CS) 40195327251773; qq) Model Number DYNJ909000, UDI/DI (EA) 10195327238100, UDI/DI (CS) 40195327238101; rr) Model Number DYNJ909002, UDI/DI (EA) 10195327238148, UDI/DI (CS) 40195327238149; ss) Model Number DYNJ909198A, UDI/DI (EA) 10195327414788, UDI/DI (CS) 40195327414789; tt) Model Number DYNJ9428703Q, UDI/DI (EA) 10195327329174, UDI/DI (CS) 40195327329175; uu) Model Number DYNJ9428745R, UDI/DI (EA) 10195327258368, UDI/DI (CS) 40195327258369; vv) Model Number DYNJ9428787O, UDI/DI (EA) 10195327328795, UDI/DI (CS) 40195327328795; All lots within expiry, distributed from Medline between December 2017 - May 2023:

Where was it sold?

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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