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RecallWatchMedical Device Safety
Class IIOngoingZ-1417-2026

Medline Industries, LP recalls Medline Convenience Kits: 1) C-SECTION PACK

Medline Industries, LPNorthfield, IL, United StatesReported Feb 25, 2026 · 4 months ago
Legal News Analyst ·

Reason for recall

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model Number: DYNJ15494G; 7) C-SECTION TRAY-LF, Model Number: DYNJ19529P; 8) C-SECTION TRAY-LF, Model Number: DYNJ19529Q; 9) C-SECTION TRAY-LF, Model Number: DYNJ19529R; 10) C-SECTION TRAY-LF, Model Number: DYNJ19529S; 11) C-SECTION PACK-LF, Model Number: DYNJ21550Q; 12) C-SECTION PACK, Model Number: DYNJ23544F; 13) C-SECTION PACK, Model Number: DYNJ32632F; 14) C-SECTION PACK QVH-LF, Model Number: DYNJ35100I; 15) C-SECTION PACK-LF, Model Number: DYNJ38801F; 16) SCRIPPS SW C-SECTION PACK-LF, Model Number: DYNJ40129C; 17) C-SECTION, Model Number: DYNJ41444F; 18) C-SECTION PACK, Model Number: DYNJ49224I; 19) C SECTION PACK-LF, Model Number: DYNJ52387I; 20) C-SECTION PACK, Model Number: DYNJ56523C; 21) C-SECTION PACK, Model Number: DYNJ59387L; 22) C-SECTION PACK, Model Number: DYNJ64549B; 23) C SECTION PACK, Model Number: DYNJ67347A; 24) C SECTION PACK, Model Number: DYNJ69778A; 25) B-C SECTION BAYSTATE, Model Number: DYNJ900602I; 26) B-C SECTION BAYSTATE, Model Number: DYNJ900602K; 27) PAD C-SECTION, Model Number: DYNJ902134C; 28) RICH C-SECTION, Model Number: DYNJ902182J; 29) C-SECTION PACK, Model Number: DYNJ904329D; 30) C-SECTION, Model Number: DYNJ904697F; 31) KIT C SECTION, Model Number: DYNJ906966G; 32) C SECTION, Model Number: DYNJ907999A; 33) C-SECTION, Model Number: DYNJ909058; 34) C-SECTION PACK, Model Number: DYNJ909507; 35) C SECTION TRAY, Model Number: DYNJT3407; 36) TR-C SECTION PACK-LF, Model Number: PHS583549002B

Lot / code information

UDI
10195327278014(each), 40195327278015(case)
Lot #
23IMB818; 2) CDS983523G
UDI
10195327283681(each), 40195327283682(case)
Lot #
23IBS984; 3) CDSCCR611O
UDI
10193489367904(each), 40193489367905(case)
Lot #
21WBA953; 4) CDSCCR611O
UDI
10193489367904(each), 40193489367905(case)
Lot #
21LBC555; 5) CDSCCR611O
UDI
10193489367904(each), 40193489367905(case)
Lot #
21CBN328; 6) CDSCCR611P
Show 140 more code fields
UDI
10195327065850(each), 40195327065851(case)
Lot #
22IBG757; 7) CDSCCR611P
UDI
10195327065850(each), 40195327065851(case)
Lot #
22FBU298; 8) CDSCCR611P
UDI
10195327065850(each), 40195327065851(case)
Lot #
22FBU297; 9) CDSCCR611P
UDI
10195327065850(each), 40195327065851(case)
Lot #
22FBU296; 10) CDSCCR611P
UDI
10195327065850(each), 40195327065851(case)
Lot #
22EBA155; 11) CDSCCR611P
UDI
10195327065850(each), 40195327065851(case)
Lot #
22BBT090; 12) CDSCCR611P
UDI
10195327065850(each), 40195327065851(case)
Lot #
22BBH774; 13) DYNJ0101616I
UDI
10193489248814(each), 40193489248815(case)
Lot #
21ADA105; 14) DYNJ15494G
UDI
10193489961195(each), 40193489961196(case)
Lot #
22LBS122; 15) DYNJ19529P
UDI
10195327529338(each), 40195327529339(case)
Lot #
24GMF054; 16) DYNJ19529P
UDI
10195327529338(each), 40195327529339(case)
Lot #
24FMB372; 17) DYNJ19529P
UDI
10195327529338(each), 40195327529339(case)
Lot #
24EMB123; 18) DYNJ19529P
UDI
10195327529338(each), 40195327529339(case)
Lot #
24AMD085; 19) DYNJ19529P
UDI
10195327529338(each), 40195327529339(case)
Lot #
23LME909; 20) DYNJ19529Q
UDI
10198459109362(each), 40198459109363(case)
Lot #
25BMB041; 21) DYNJ19529Q
UDI
10198459109362(each), 40198459109363(case)
Lot #
24LMH886; 22) DYNJ19529Q
UDI
10198459109362(each), 40198459109363(case)
Lot #
24KMD458; 23) DYNJ19529R
UDI
10198459311031(each), 40198459311032(case)
Lot #
25IMA090; 24) DYNJ19529R
UDI
10198459311031(each), 40198459311032(case)
Lot #
25FMI427; 25) DYNJ19529S
UDI
10198459566257(each), 40198459566258(case)
Lot #
25KMA045; 26) DYNJ21550Q
UDI
10193489830910(each), 40193489830911(case)
Lot #
21DBL994; 27) DYNJ21550Q
UDI
10193489830910(each), 40193489830911(case)
Lot #
21DBJ153; 28) DYNJ21550Q
UDI
10193489830910(each), 40193489830911(case)
Lot #
21BBM422; 29) DYNJ23544F
UDI
10889942533053(each), 40889942533054(case)
Lot #
23IMA860; 30) DYNJ32632F
UDI
10193489888966(each), 40193489888967(case)
Lot #
22HMC526; 31) DYNJ35100I
UDI
10195327097608(each), 40195327097609(case)
Lot #
23IME105; 32) DYNJ38801F
UDI
10195327113117(each), 40195327113118(case)
Lot #
23IBK585; 33) DYNJ40129C
UDI
10193489441772(each), 40193489441773(case)
Lot #
23AMJ303; 34) DYNJ41444F
UDI
10193489740974(each), 40193489740975(case)
Lot #
22JMB590; 35) DYNJ49224I
UDI
10193489371352(each), 40193489371353(case)
Lot #
21DDA358; 36) DYNJ52387I
UDI
10193489248272(each), 40193489248273(case)
Lot #
21ADA540; 37) DYNJ56523C
UDI
10193489430264(each), 40193489430265(case)
Lot #
21ABS513; 38) DYNJ59387L
UDI
10195327159856(each), 40195327159857(case)
Lot #
23CBK420; 39) DYNJ64549B
UDI
10193489940725(each), 40193489940726(case)
Lot #
23ABL355; 40) DYNJ67347A
UDI
10195327046156(each), 40195327046157(case)
Lot #
22JMF954; 41) DYNJ69778A
UDI
10195327334420(each), 40195327334421(case)
Lot #
23CBU899; 42) DYNJ900602I
UDI
10193489487121(each), 40193489487122(case)
Lot #
20LDB302; 43) DYNJ900602K
UDI
10193489937190(each), 40193489937191(case)
Lot #
25JDA979; 44) DYNJ902134C
UDI
10193489452280(each), 40193489452281(case)
Lot #
21DBP451; 45) DYNJ902182J
UDI
10193489452914(each), 40193489452915(case)
Lot #
23ABM580; 46) DYNJ902182J
UDI
10193489452914(each), 40193489452915(case)
Lot #
22OBJ456; 47) DYNJ902182J
UDI
10193489452914(each), 40193489452915(case)
Lot #
22JBO865; 48) DYNJ902182J
UDI
10193489452914(each), 40193489452915(case)
Lot #
22IBI254; 49) DYNJ902182J
UDI
10193489452914(each), 40193489452915(case)
Lot #
22HBF417; 50) DYNJ902182J
UDI
10193489452914(each), 40193489452915(case)
Lot #
22GBH232; 51) DYNJ902182J
UDI
10193489452914(each), 40193489452915(case)
Lot #
22EBG610; 52) DYNJ902182J
UDI
10193489452914(each), 40193489452915(case)
Lot #
22DBN664; 53) DYNJ902182J
UDI
10193489452914(each), 40193489452915(case)
Lot #
22ABY311; 54) DYNJ902182J
UDI
10193489452914(each), 40193489452915(case)
Lot #
21JBX738; 55) DYNJ902182J
UDI
10193489452914(each), 40193489452915(case)
Lot #
21JBJ172; 56) DYNJ902182J
UDI
10193489452914(each), 40193489452915(case)
Lot #
21IBL808; 57) DYNJ902182J
UDI
10193489452914(each), 40193489452915(case)
Lot #
21GBB842; 58) DYNJ902182J
UDI
10193489452914(each), 40193489452915(case)
Lot #
21CBS046; 59) DYNJ902182J
UDI
10193489452914(each), 40193489452915(case)
Lot #
21CBQ743; 60) DYNJ902182J
UDI
10193489452914(each), 40193489452915(case)
Lot #
21BBF750; 61) DYNJ904329D
UDI
10198459221071(each), 40198459221072(case)
Lot #
25EBJ650; 62) DYNJ904697F
UDI
10195327169275(each), 40195327169276(case)
Lot #
22FDA703; 63) DYNJ906966G
UDI
10195327557959(each), 40195327557950(case)
Lot #
24IBS185; 64) DYNJ906966G
UDI
10195327557959(each), 40195327557950(case)
Lot #
24IBF270; 65) DYNJ906966G
UDI
10195327557959(each), 40195327557950(case)
Lot #
24GBV882; 66) DYNJ906966G
UDI
10195327557959(each), 40195327557950(case)
Lot #
24GBR695; 67) DYNJ906966G
UDI
10195327557959(each), 40195327557950(case)
Lot #
24DBN053; 68) DYNJ906966G
UDI
10195327557959(each), 40195327557950(case)
Lot #
24BBV274; 69) DYNJ907999A
UDI
10193489996814(each), 40193489996815(case)
Lot #
22CMH174; 70) DYNJ907999A
UDI
10193489996814(each), 40193489996815(case)
Lot #
21LMB616; 71) DYNJ907999A
UDI
10193489996814(each), 40193489996815(case)
Lot #
21JMC590; 72) DYNJ909058
UDI
10195327259327(each), 40195327259328(case)
Lot #
23EBP308; 73) DYNJ909507
UDI
10195327387075(each), 40195327387076(case)
Lot #
23GME519; 74) DYNJT3407
UDI
10198459324970(each), 40198459324971(case)
Lot #
25EBK673; 75) PHS583549002B
UDI
10193489643558(each), 40193489643559(case)
Lot #
21ADA554

What the firm is doing

An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers regarding Proxima Sterile Surgical Gowns, Packs, and Drapes. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-26-003 Recall Code: 3. Your account will receive credit once the response form is submitted. 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers regarding Medline Kits containing Proxima Sterile Surgical Gowns and Drapes. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-003-FGX1 Recall Code: 3. Upon receipt of your submitted response form,

DistributionShow details

Worldwide distribution - US Nationwide.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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