Recall archive / FDA device enforcement

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20... — FDA record Z-2319-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 15, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC4740; b. A V GRAFT, Model Number: DYNJ36212C; c. AAA, Model Number: DYNJ905651, DYNJ905651A, DYNJ905651B; d. AAA PACK, Model Number: DYNJ44918C; e. AAA PACK - TEAM 3, Model Number: DYNJ44847G; f. ABLATION PACK, Model Number: DYNJ62540, DYNJ64068; g. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658A; h. ACCESS KIT, Model Number: DYNDH1159A; i. ACCESS PACK, Model Number: DYNJ69017; j. ACCESSORY KIT, Model Number: DYNJ901348D; k. ADULT CORONARY PACK, Model Number: DYNJV0275F; l. ADULT CVC MAX BARRIER KIT-LF, Model Number: DYNJ38714B; m. ALL PURPOSE TRAY FOAKS, Model Number: DYNJ63576, DYNJ63576A; n. AMINO KIT; Model Number: DYNDH1649; o. AMNIOCENTESIS TRAY, Model Number: DYNDH1420; p. ANGIO STANDARD PACK-LF, Model Number: DYNJ0370436Q; q. ANGIO TRAY, Model Number: DYNJ23438J; r. ANGIOGRAM PACK, Model Number: DYNJ47004B; s. ANGIOGRAM TRAY, Model Number: DYNJ33638I; t. ANGIO-VASCULAR, Model Number: DYNJ24272B; u. ARTERIAL PACK, Model Number: DYNJ51340D; v. ARTERIO-VENOUS CDS, Model Number: CDS984186C; w. ASPIRATION TRAY, Model Number: DYNDH1467; x. ASPIRE EXACT TRAY, Model Number: DYNJRA1716, DYNJRA1716A; y. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299L; z. BASIC PACK, Model Number: DYNJ37460A, DYNJ42691, DYNJ52122B, DYNJ52171, DYNJ55456, DYNJ55457, DYNJ81343; aa. BASIC PROCEDURE PACK, Model Number: DYNJ53122B; bb. BASIC VEIN PACK, Model Number: DYNJ58650; cc. BEDSIDE PROCEDURE PREP KIT, Model Number: MNS7695A; dd. BGMC LIVER TRANSPLANT, Model Number: DYNJ9664651D; ee. BIOPSY TRAY, Model Number: DYNDH1340; ff. BLOCK KIT, Model Number: DYNJRA1145; gg. BLOCK SUPPLIES NDL CNTR, Model Number: DYNJRA1755; hh. BREAST ULTRASOUND PROCEDURE TR, Model Number: DYNDL1596A; ii. BUNDLE KIT, Model Number: DYNJ49737B, DYNJ49737C; jj. C V MAJOR PACK, Model Number: DYNJ64861; kk. CABG UNIVERSITY HOSP PACK-LF, Model Number: DYNJ0375705L; ll. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640; mm. CHEST TUBE INSERTION TRAY, Model Number: TRICHT1120; nn. CHP TRANSPLANT CDS, Model Number: CDS983082I, CDS983082J; oo. CLINIC PACK, Model Number: DYNJRA1578; pp. CLOSURE CDS, Model Number: CDS983704G, CDS983704I; qq. CLOSURE FAST PACK UNIV, Model Number: DYNJ53482A; rr. CLOSURE PACK, Model Number: DYNJ54437A, DYNJ54437C, DYNJ57514, DYNJ60804; ss. CLOSURE PACK-LF, Model Number: DYNJ0807503M; tt. CLOSURE PROCEDURE, Model Number: DYNJ59206; uu. CLOSURE PROCEDURE PACK, Model Number: DYNJ66741; vv. CLOSURE PROCEDURE PKSJO-LF, Model Number: DYNJ35409F; ww. CLOT RETRIEVAL PACK, Model Number: DYNJ56140B; xx. CLOVIS MINOR IR PROCEDURE-LF, Model Number: DYNJ61067; yy. COMMANDO PACK MSH-LF, Model Number: DYNJ48525D; zz. CONTINUOUS BLOCK, Model Number: DYNJRA0960B; aaa. COPS PROCEDURE PACK-LF, Model Number: DYNJ68923A; bbb. CRMC MINOR IR PROCEDURE PK-LF, Model Number: DYNJ61099, DYNJ61099A; ccc. CV AAA PACK W AUX, Mode...
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Classification: Class II
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 83,541 kits
Agency-reported status: Ongoing
Source record identifier: Z-2319-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: ECVC4740, UPC Number: 10653160335214. b. Model Number: DYNJ36212C, UPC Number: 088994288566. c. Model Number: DYNJ905651, UPC Number: 088827778831; Model Number: DYNJ905651A, UPC Number: 019348968651; Model Number: DYNJ905651B, UPC Number: 019348992506. d. Model Number: DYNJ44918C, UPC Number: 019348976679. e. Model Number: DYNJ44847G, UPC Number: 019348962983. f. Model Number: DYNJ62540, UPC Number: 019348966647; Model Number: DYNJ64068, UPC Number: 019348978313. g. Model Number: DYNJ53658A, UPC Number: 088994268440. h. Model Number: DYNDH1159A, UPC Number: 088994288165. i. Model Number: DYNJ69017, UPC Number: 019348987815. j. Model Number: DYNJ901348D, UPC Number: 019348959468. k. Model Number: DYNJV0275F, UPC Number: 019348926312. l. Model Number: DYNJ38714B, UPC Number: 088994260193. m. Model Number: DYNJ63576, UPC Number: 019348976954; Model Number: DYNJ63576A, UPC Number: 019348942925. n. Model Number: DYNDH1649, UPC Number: 019348994436. o. Model Number: DYNDH1420, UPC Number: 019348936044. p. Model Number: DYNJ0370436Q, UPC Number: 088827777928. q. Model Number: DYNJ23438J, UPC Number: 019348956435. r. Model Number: DYNJ47004B, UPC Number: 088827775429. s. Model Number: DYNJ33638I, UPC Number: 019348956435. t. Model Number: DYNJ24272B, UPC Number: 019348956435. u. Model Number: DYNJ51340D, UPC Number: 019348956981. v. Model Number: CDS984186C, UPC Number: 088994295750. w. Model Number: DYNDH1467, UPC Number: 019348943966. x. Model Number: DYNJRA1716, UPC Number: 019348926312; Model Number: DYNJRA1716A, UPC Number: 019348989641. y. Model Number: DYNJC9299L, UPC Number: 019348926312. z. Model Number: DYNJ37460A, UPC Number: 088827756043; Model Number: DYNJ42691, UPC Number: 088827700350; Model Number: DYNJ52122B, UPC Number: 019348993530; Model Number: DYNJ52171, UPC Number: 088994224347; Model Number: DYNJ55456, UPC Number: 088994254844; Model Number: DYNJ55457, UPC Number: 088994254846; Model Number: DYNJ81343, UPC Number: 019532711306. aa. Model Number: DYNJ53122B, UPC Number: 019348932122. bb. Model Number: DYNJ58650, UPC Number: 088994287665. cc. Model Number: MNS7695A, UPC Number: 065316034345. dd. Model Number: DYNJ9664651D, UPC Number: 019348939642. ee. Model Number: DYNDH1340, UPC Number: 088994289450. ff. Model Number: DYNJRA1145, UPC Number: 088994292854. gg. Model Number: DYNJRA1755, UPC Number: 019348984284. hh. Model Number: DYNDL1596A, UPC Number: 088438992650. ii. Model Number: DYNJ49737B, UPC Number: 019348939440; Model Number: DYNJ49737C, UPC Number: 019532723588. jj. Model Number: DYNJ64861, UPC Number: 019348922377. kk. Model Number: DYNJ0375705L, UPC Number: 019348954413. ll. Model Number: DYNJ905640, UPC Number: 019348952767. mm. Model Number: TRICHT1120, UPC Number: 065316031829. nn. Model Number: CDS983082I, UPC Number: 088994277286; Model Number: CDS983082J, UPC Number: 019348967451. oo. Model Number: DYNJRA1578, UPC Number: 019348927278. pp. Model Number: CDS983704G, UPC Number: 088994280844; Model Number: CDS983704I, UPC Number: 019348985455. qq. Model Number: DYNJ53482A, UPC Number: 088994291731. rr. Model Number: DYNJ54437A, UPC Number: 088994256796; Model Number: DYNJ54437C, UPC Number: 019348924397; Model Number: DYNJ57514, UPC Number: 088994274784; Model Number: DYNJ60804, UPC Number: 019348953278. ss. Model Number: DYNJ0807503M, UPC Number: 088994209173. tt. Model Number: DYNJ59206, UPC Number: 088827776557. uu. Model Number: DYNJ66741, UPC Number: 019348937494. vv. Model Number: DYNJ35409F, UPC Number: 088827777124. ww. Model Number: DYNJ56140B, UPC Number: 019348954767. xx. Model Number: DYNJ61067, UPC Number: 019348954222. yy. Model Number: DYNJ48525D, UPC Number: 019348975077. zz. Model Number: DYNJRA0960B, UPC Number: 019348926312. aaa. Model Number: DYNJ68923A, UPC Number: 019532707079. bbb. Model Number: DYNJ61099, UPC Number: 019348954424; Model Number: DYNJ61099A, UPC Number: 019348946396. ccc. Model Number: DYNJ65710, UPC Number: 019348928508. ddd. Model Number: DYNJ41875B, UPC Number: 019348956307. eee. Model Number: CDS985395C, UPC Number: 088994286348. fff. Model Number: CDS984100T, UPC Number: 019348939994. ggg. Model Number: DYNJ45074B, UPC Number: 088994284064. hhh. Model Number: DYNJ44010, UPC Number: 088827707945. iii. Model Number: DYNJ00281N, UPC Number: 019348956435. jjj. Model Number: CDS840198V, UPC Number: 088994295567. kkk. Model Number: DYNJ41915A, UPC Number: 088827756881. lll. Model Number: DYNJ52185F, UPC Number: 019348936871. mmm. Model Number: DYNJ906543A, UPC Number: 019348981803. nnn. Model Number: DYNJ55458, UPC Number: 088994254845. ooo. Model Number: DYNJ0747885F, UPC Number: 019348956435. ppp. Model Number: DYNJ0426069M, UPC Number: 019532720575. qqq. Model Number: DYNJ55669F, UPC Number: 019532731371. rrr. Model Number: DYNJ66258A, UPC Number: 019532719423. sss. Model Number: DYNJ66620A, UPC Number: 019348991424. ttt. Model Number: CDS984379D, UPC Number: 088994272434. uuu. Model Number: DYNJ0604540Q, UPC Number: 019348983968. vvv. Model Number: DYNJ38563O, UPC Number: 019348925174. www. Model Number: DYNJ905936B, UPC Number: 019348942281. xxx. Model Number: DYNJ906902A, UPC Number: 019348997120. yyy. Model Number: DYNJ900337A, UPC Number: 088994219386. zzz. Model Number: DYNJ58160, UPC Number: 088994282864. aaaa. Model Number: DYNDA2769, UPC Number: 019348945716. bbbb. Model Number: DYNJ68923, UPC Number: 019348985856. cccc. Model Number: CDS984329J, UPC Number: 088994286535. dddd. Model Number: CDS984327I, UPC Number: 088994286537. eeee. Model Number: DYNJ33546K, UPC Number: 019348991717. ffff. Model Number: DYNJ908752, UPC Number: 019532717136. gggg. Model Number: DYNJ53845A, UPC Number: 088994253675. hhhh. Model Number: DYNJ68959, UPC Number: 019348986686. iiii. Model Number: DYNJ48454, UPC Number: 088827759528. jjjj. Model Number: DYNJ60128A, UPC Number: 019348954451. kkkk. Model Number: DYNJ907279, UPC Number: 019348938641. llll. Model Number: DYNJ31934D, UPC Number: 019532707150. mmmm. Model Number: DYNDA2011B, UPC Number: 019348953302. nnnn. Model Number: DYNJ59377, UPC Number: 088827773629. oooo. Model Number: DYNJRA0585, UPC Number: 088827758069. pppp. Model Number: DYNJ83438, UPC Number: 019532726659. qqqq. Model Number: DYNJ35457B, UPC Number: 019348956435. rrrr. Model Number: DYNJ905702B, UPC Number: 019348958721. ssss. Model Number: DYNJ66867, UPC Number: 019348939016. tttt. Model Number: DYNJ60669A, UPC Number: 019348920588; Model Number: DYNJ60669B, UPC Number: 019348987734; Model Number: DYNJ63156A, UPC Number: 019348985231; Model Number: DYNJ64964A, UPC Number: 019348935382. uuuu. Model Number: DYNJ82575, UPC Number: 019532719811. vvvv. Model Number: DYNJ0426069M, UPC Number: 019532720575. wwww. Model Number: DYNJRA1226A, UPC Number: 019348956964. xxxx. Model Number: DYNJ66283A, UPC Number: 019348940904. yyyy. Model Number: DYNJ907552, UPC Number: 019348949583. zzzz. Model Number: DYNJ0351069, UPC Number: 088994205905.

Label field

Details supplied by the agency

Lot, code or applicability

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: ECVC4740, UPC Number: 10653160335214. b. Model Number: DYNJ36212C, UPC Number: 088994288566. c. Model Number: DYNJ905651, UPC Number: 088827778831; Model Number: DYNJ905651A, UPC Number: 019348968651; Model Number: DYNJ905651B, UPC Number: 019348992506. d. Model Number: DYNJ44918C, UPC Number: 019348976679. e. Model Number: DYNJ44847G, UPC Number: 019348962983. f. Model Number: DYNJ62540, UPC Number: 019348966647; Model Number: DYNJ64068, UPC Number: 019348978313. g. Model Number: DYNJ53658A, UPC Number: 088994268440. h. Model Number: DYNDH1159A, UPC Number: 088994288165. i. Model Number: DYNJ69017, UPC Number: 019348987815. j. Model Number: DYNJ901348D, UPC Number: 019348959468. k. Model Number: DYNJV0275F, UPC Number: 019348926312. l. Model Number: DYNJ38714B, UPC Number: 088994260193. m. Model Number: DYNJ63576, UPC Number: 019348976954; Model Number: DYNJ63576A, UPC Number: 019348942925. n. Model Number: DYNDH1649, UPC Number: 019348994436. o. Model Number: DYNDH1420, UPC Number: 019348936044. p. Model Number: DYNJ0370436Q, UPC Number: 088827777928. q. Model Number: DYNJ23438J, UPC Number: 019348956435. r. Model Number: DYNJ47004B, UPC Number: 088827775429. s. Model Number: DYNJ33638I, UPC Number: 019348956435. t. Model Number: DYNJ24272B, UPC Number: 019348956435. u. Model Number: DYNJ51340D, UPC Number: 019348956981. v. Model Number: CDS984186C, UPC Number: 088994295750. w. Model Number: DYNDH1467, UPC Number: 019348943966. x. Model Number: DYNJRA1716, UPC Number: 019348926312; Model Number: DYNJRA1716A, UPC Number: 019348989641. y. Model Number: DYNJC9299L, UPC Number: 019348926312. z. Model Number: DYNJ37460A, UPC Number: 088827756043; Model Number: DYNJ42691, UPC Number: 088827700350; Model Number: DYNJ52122B, UPC Number: 019348993530; Model Number: DYNJ52171, UPC Number: 088994224347; Model Number: DYNJ55456, UPC Number: 088994254844; Model Number: DYNJ55457, UPC Number: 088994254846; Model Number: DYNJ81343, UPC Number: 019532711306. aa. Model Number: DYNJ53122B, UPC Number: 019348932122. bb. Model Number: DYNJ58650, UPC Number: 088994287665. cc. Model Number: MNS7695A, UPC Number: 065316034345. dd. Model Number: DYNJ9664651D, UPC Number: 019348939642. ee. Model Number: DYNDH1340, UPC Number: 088994289450. ff. Model Number: DYNJRA1145, UPC Number: 088994292854. gg. Model Number: DYNJRA1755, UPC Number: 019348984284. hh. Model Number: DYNDL1596A, UPC Number: 088438992650. ii. Model Number: DYNJ49737B, UPC Number: 019348939440; Model Number: DYNJ49737C, UPC Number: 019532723588. jj. Model Number: DYNJ64861, UPC Number: 019348922377. kk. Model Number: DYNJ0375705L, UPC Number: 019348954413. ll. Model Number: DYNJ905640, UPC Number: 019348952767. mm. Model Number: TRICHT1120, UPC Number: 065316031829. nn. Model Number: CDS983082I, UPC Number: 088994277286; Model Number: CDS983082J, UPC Number: 019348967451. oo. Model Number: DYNJRA1578, UPC Number: 019348927278. pp. Model Number: CDS983704G, UPC Number: 088994280844; Model Number: CDS983704I, UPC Number: 019348985455. qq. Model Number: DYNJ53482A, UPC Number: 088994291731. rr. Model Number: DYNJ54437A, UPC Number: 088994256796; Model Number: DYNJ54437C, UPC Number: 019348924397; Model Number: DYNJ57514, UPC Number: 088994274784; Model Number: DYNJ60804, UPC Number: 019348953278. ss. Model Number: DYNJ0807503M, UPC Number: 088994209173. tt. Model Number: DYNJ59206, UPC Number: 088827776557. uu. Model Number: DYNJ66741, UPC Number: 019348937494. vv. Model Number: DYNJ35409F, UPC Number: 088827777124. ww. Model Number: DYNJ56140B, UPC Number: 019348954767. xx. Model Number: DYNJ61067, UPC Number: 019348954222. yy. Model Number: DYNJ48525D, UPC Number: 019348975077. zz. Model Number: DYNJRA0960B, UPC Number: 019348926312. aaa. Model Number: DYNJ68923A, UPC Number: 019532707079. bbb. Model Number: DYNJ61099, UPC Number: 019348954424; Model Number: DYNJ61099A, UPC Number: 019348946396. ccc. Model Number: DYNJ65710, UPC Number: 019348928508. ddd. Model Number: DYNJ41875B, UPC Number: 019348956307. eee. Model Number: CDS985395C, UPC Number: 088994286348. fff. Model Number: CDS984100T, UPC Number: 019348939994. ggg. Model Number: DYNJ45074B, UPC Number: 088994284064. hhh. Model Number: DYNJ44010, UPC Number: 088827707945. iii. Model Number: DYNJ00281N, UPC Number: 019348956435. jjj. Model Number: CDS840198V, UPC Number: 088994295567. kkk. Model Number: DYNJ41915A, UPC Number: 088827756881. lll. Model Number: DYNJ52185F, UPC Number: 019348936871. mmm. Model Number: DYNJ906543A, UPC Number: 019348981803. nnn. Model Number: DYNJ55458, UPC Number: 088994254845. ooo. Model Number: DYNJ0747885F, UPC Number: 019348956435. ppp. Model Number: DYNJ0426069M, UPC Number: 019532720575. qqq. Model Number: DYNJ55669F, UPC Number: 019532731371. rrr. Model Number: DYNJ66258A, UPC Number: 019532719423. sss. Model Number: DYNJ66620A, UPC Number: 019348991424. ttt. Model Number: CDS984379D, UPC Number: 088994272434. uuu. Model Number: DYNJ0604540Q, UPC Number: 019348983968. vvv. Model Number: DYNJ38563O, UPC Number: 019348925174. www. Model Number: DYNJ905936B, UPC Number: 019348942281. xxx. Model Number: DYNJ906902A, UPC Number: 019348997120. yyy. Model Number: DYNJ900337A, UPC Number: 088994219386. zzz. Model Number: DYNJ58160, UPC Number: 088994282864. aaaa. Model Number: DYNDA2769, UPC Number: 019348945716. bbbb. Model Number: DYNJ68923, UPC Number: 019348985856. cccc. Model Number: CDS984329J, UPC Number: 088994286535. dddd. Model Number: CDS984327I, UPC Number: 088994286537. eeee. Model Number: DYNJ33546K, UPC Number: 019348991717. ffff. Model Number: DYNJ908752, UPC Number: 019532717136. gggg. Model Number: DYNJ53845A, UPC Number: 088994253675. hhhh. Model Number: DYNJ68959, UPC Number: 019348986686. iiii. Model Number: DYNJ48454, UPC Number: 088827759528. jjjj. Model Number: DYNJ60128A, UPC Number: 019348954451. kkkk. Model Number: DYNJ907279, UPC Number: 019348938641. llll. Model Number: DYNJ31934D, UPC Number: 019532707150. mmmm. Model Number: DYNDA2011B, UPC Number: 019348953302. nnnn. Model Number: DYNJ59377, UPC Number: 088827773629. oooo. Model Number: DYNJRA0585, UPC Number: 088827758069. pppp. Model Number: DYNJ83438, UPC Number: 019532726659. qqqq. Model Number: DYNJ35457B, UPC Number: 019348956435. rrrr. Model Number: DYNJ905702B, UPC Number: 019348958721. ssss. Model Number: DYNJ66867, UPC Number: 019348939016. tttt. Model Number: DYNJ60669A, UPC Number: 019348920588; Model Number: DYNJ60669B, UPC Number: 019348987734; Model Number: DYNJ63156A, UPC Number: 019348985231; Model Number: DYNJ64964A, UPC Number: 019348935382. uuuu. Model Number: DYNJ82575, UPC Number: 019532719811. vvvv. Model Number: DYNJ0426069M, UPC Number: 019532720575. wwww. Model Number: DYNJRA1226A, UPC Number: 019348956964. xxxx. Model Number: DYNJ66283A, UPC Number: 019348940904. yyyy. Model Number: DYNJ907552, UPC Number: 019348949583. zzzz. Model Number: DYNJ0351069, UPC Number: 088994205905.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Aug 9, 2023
Recall initiation date: May 15, 2023
Center classification date: Aug 3, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records