Recall archive / FDA device enforcement

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO,... — FDA record Z-2296-2023

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. ANGIO, Model Number: DYNJ902507B; b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F; c. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K, DYNJ43609L, DYNJ43609M, DYNJ43609N; d. ANGIO DRAPE PACK, Model Number: DYNJ17624B, DYNJ44320F; e. ANGIO DRAPE SPEC PROC PACK, Model Number: DYNJ47951A; f. ANGIO LEFT HEART PACK, Model Number: DYNJ40632C; g. ANGIO PACK, Model Numbers: DYNJ30141, DYNJ34361, DYNJ42903B, DYNJ43661B, DYNJ47226A, DYNJ50624A, DYNJ51239A, DYNJ58111C, DYNJ58126A, DYNJ62299, DYNJ62544, DYNJ65043A, DYNJ66398A, DYNJ66398B; h. ANGIO PACK 2-A, Model Number: DYNJ60507A; i. ANGIO PACK-LF, Model Numbers: DYNJ0373279L, DYNJ0373279M; j. ANGIO TRAY, Model Numbers: DYNJ46153A, DYNJ46153B, DYNJ52121; k. ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; l. ANGIO/PICC PACK, Model Number: DYNJ36049; m. ANGIOGRAM, Model Number: DYNJ0149444M; n. ANGIOGRAM PACK, Model Numbers: DYNJ45007, DYNJ47004C, DYNJ66244; o. ANGIOGRAM TRAY, Model Number: DYNJ33638K; p. ANGIOGRAPHY DRAPE PACK, Model Numbers: DYNJ49621B, DYNJ63060A, DYNJ63684F, DYNJ68065, DYNJ68065A, DYNJT2344B; q. ANGIOGRAPHY DRAPE PACK-LF, Model Numbers: DYNJ28067G, DYNJVB1135A; r. ANGIOGRAPHY DRP PK PEDI CATH, Model Numbers: 00-401318L, 00-401318M; s. ANGIOGRAPHY OR, Model Number: CDS984944C; t. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293D, DYNJ47906, DYNJ55252B, DYNJ57498, DYNJ65190C, DYNJ66476, DYNJC2371G; u. ANGIOGRAPHY PACK-LF, Model Number: DYNJ0854485T; v. ANGIOPLASTY PACK-LF, Model Numbers: DYNJ43203F, DYNJ64655A; w. CATH LAB PACK, Model Number: DYNJ65185; x. CLOVIS CATH LAB PACK, Model Number: DYNJ62379; y. CUSTOM ANGIO TRAY, Model Number: DYNJ41649F; z. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367A; aa. DASHTI-YAO NEURO ANGIO-LF, Model Number: DYNJ33457C; bb. DBD-ANGIO TRAY, Model Number: DYNJ68758; cc. DBD-CATH PACK, Model Number: DYNJ63527; dd. DBD-CLOVIS CATH LAB PACK, Model Number: DYNJ62379; ee. DEPAUL ANGIO PACK, Model Number: DYNJ19939M; ff. EH VASCULAR ANGIO, Model Number: DYNJ49931F; gg. ENDOVASCULAR KIT, Model Number: DYNJ906354C; hh. EP ANGIOGRAPHY PACK, Model Number: DYNJ24225K; ii. FEMORAL ANGIOGRAPY SET UP, Model Number: DYNJ61015B; jj. FS ANGIO, Model Number: DYNJ42499C; kk. GENERAL ANGIO PACK, Model Number: DYNJ57760B; ll. HH ANGIO PACK, Model Number: DYNJ59465B; mm. IPMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0806254D; nn. IR MINOR ANGIO PACK, Model Number: DYNJ37665B; oo. KENNESTONE ANGIO, Model Number: WK100B; pp. MH HOOD CARDIAC ANGIO, Model Numbers: DYNJ49884B, DYNJ49884F; qq. MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553D; rr. OR ANGIO PACK, Model Number: DYNJ60319A; ss. OR ANGIOGRAPHY PACK, Model Number: DYNJ67245; tt. PACK,BASIC ANGIO, Model Number: DYNJ65482A; uu. PEDI ANGIO PACK-LF, Model Number: PHS41743D; vv. PEDIATRIC CATH ANGIO PACK, Model Numbers: DYNJ54755D, DYNJ54755F; ww. PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112; xx. ...
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: 63,823 kits
Agency-reported status: Ongoing
Source record identifier: Z-2296-2023

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: DYNJ902507B, UPC Number: 088994278118. b. Model Number: DYNJ46043D, UPC Number: 019348935036; Model Number: DYNJ46043F, UPC Number: 019348985672. c. Model Number: DYNJ43609K, UPC Number: 019348950140; Model Number: DYNJ43609L, UPC Number 019348960178; Model Number: DYNJ43609M, UPC Number 019348962744; Model Number: DYNJ43609N, UPC Number 019348928212. d. Model Number: DYNJ17624B, UPC Number: 019348986729; Model Number: DYNJ44320F, UPC Number 019348943551. e. Model Number: DYNJ47951A, UPC Number: 019348960984. f. Model Number: DYNJ40632C, UPC Number: 019348946117. g. Model Number: DYNJ30141, UPC Number: 019348956435; Model Number: DYNJ34361, UPC Number 088438934847; Model Number: DYNJ42903B, UPC Number: 088827779801; Model Number: DYNJ43661B, UPC Number 088994280870; Model Number: DYNJ47226A, UPC Number: 088827756181; Model Number: DYNJ50624A, UPC Number 088994247463; Model Number: DYNJ51239A, UPC Number: 088994249354; Model Number: DYNJ58111C, UPC Number 019348984600; Model Number: DYNJ58126A, UPC Number: 019348948475; Model Number: DYNJ62299, UPC Number 019348964151; Model Number: DYNJ62544, UPC Number: 019348966652; Model Number: DYNJ65043A, UPC Number 019348937932; Model Number: DYNJ66398A, UPC Number: 019348941416; Model Number: DYNJ66398B, UPC Number 019348989192. h. Model Number: DYNJ60507A, UPC Number: 019348983055. i. Model Number: DYNJ0373279L, UPC Number: 019348956435; Model Number: DYNJ0373279M, UPC Number: 019348951902. j. Model Number: DYNJ46153A, UPC Number: 088994218586; Model Number: DYNJ46153B, UPC Number: 019348985364; Model Number: DYNJ52121, UPC Number: 088994224362. k. Model Number: DYNJ62742, UPC Number: 019348968592, Lot Numbers: 21LBP049, 22OBH570, 22EBP081, 22FBG069, 20XBB252, 21BBH070, 21DBJ756. l. Model Number: DYNJ36049, UPC Number: 019348956435. m. Model Number: DYNJ0149444M, UPC Number: 019348956435. n. Model Number: DYNJ45007, UPC Number: 088827708541; Model Number: DYNJ47004C, UPC Number: 019348969617; Model Number: DYNJ66244, UPC Number: 019348932371. o. Model Number: DYNJ33638K, UPC Number: 019348934328. p. Model Number: DYNJ49621B, UPC Number: 088994228223; Model Number: DYNJ63060A, UPC Number: 019348942308; Model Number: DYNJ63684F, UPC Number: 019348989720; Model Number: DYNJ68065, UPC Number: 019348947511; Model Number: DYNJ68065A, UPC Number: 019348988872; Model Number: DYNJT2344B, UPC Number: 088994210780. q. Model Number: DYNJ28067G, UPC Number: 088994274429; Model Number: DYNJVB1135A, UPC Number: 019348933993. r. Model Number: 00-401318L, UPC Number: 088827709176; Model Number: 00-401318M, UPC Number: 019348934875. s. Model Number: CDS984944C, UPC Number: 088994217295. t. Model Number: DYNJ44293D, UPC Number: 019348983341; Model Number: DYNJ47906, UPC Number: 088827752837; Model Number: DYNJ55252B, UPC Number: 019348987015; Model Number: DYNJ57498, UPC Number: 088994274574; Model Number: DYNJ65190C, UPC Number: 019348943311; Model Number: DYNJ66476, UPC Number: 019348935677; Model Number: DYNJC2371G, UPC Number: 088994249467. u. Model Number: DYNJ0854485T, UPC Number: 019348986419. v. Model Number: DYNJ43203F, UPC Number: 019348939286; Model Number: DYNJ64655A, UPC Number: 019348986331. w. Model Number: DYNJ65185, UPC Number: 019348925314. x. Model Number: DYNJ62379, UPC Number: 019348965170. y. Model Number: DYNJ41649F, UPC Number: 019348964127. z. Model Number: DYNJ42367A, UPC Number: 088827794377. aa. Model Number: DYNJ33457C, UPC Number: 019348946180. bb. Model Number: DYNJ68758, UPC Number: 019348983756. cc. Model Number: DYNJ63527, UPC Number: 019348974839. dd. Model Number: DYNJ62379, UPC Number: 019348965170. ee. Model Number: DYNJ19939M, UPC Number: 019348939324. ff. Model Number: DYNJ49931F, UPC Number: 019348947166. gg. Model Number: DYNJ906354C, UPC Number: 019348981670. hh. Model Number: DYNJ24225K, UPC Number: 088994251070. ii. Model Number: DYNJ61015B, UPC Number: 019348936888. jj. Model Number: DYNJ42499C, UPC Number: 019532703086. kk. Model Number: DYNJ57760B, UPC Number: 019348934258. ll. Model Number: DYNJ59465B, UPC Number: 019348947093. mm. Model Number: DYNJ0806254D, UPC Number: 088994247116. nn. Model Number: DYNJ37665B, UPC Number: 088994296973. oo. Model Number: WK100B, UPC Number: 019348934875. pp. Model Number: DYNJ49884B, UPC Number: 088994236366; Model Number: DYNJ49884F, UPC Number: 019348946957. qq. Model Number: DYNJ41553D, UPC Number: 088994281133. rr. Model Number: DYNJ60319A, UPC Number: 019348927629. ss. Model Number: DYNJ67245, UPC Number: 019348939305. tt. Model Number: DYNJ65482A, UPC Number: 019348941682. uu. Model Number: PHS41743D, UPC Number: 019348945327. vv. Model Number: DYNJ54755D, UPC Number: 019348943426; Model Number: DYNJ54755F, UPC Number: 019348988460. ww. Model Number: DYNJ60112, UPC Number: 088827779984. xx. Model Number: DYNJ57645A, UPC Number: 019348955794; Model Number: DYNJ57645B, UPC Number: 019348982865. yy. Model Number: DYNJ61747A, UPC Number: 019348971965. zz. Model Number: DYNJ64830, UPC Number: 019348922313. aaa. Model Number: DYNJ66500, UPC Number: 019348935791. bbb. Model Number: DYNJ0201109AG, UPC Number: 019348949726.

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: DYNJ902507B, UPC Number: 088994278118. b. Model Number: DYNJ46043D, UPC Number: 019348935036; Model Number: DYNJ46043F, UPC Number: 019348985672. c. Model Number: DYNJ43609K, UPC Number: 019348950140; Model Number: DYNJ43609L, UPC Number 019348960178; Model Number: DYNJ43609M, UPC Number 019348962744; Model Number: DYNJ43609N, UPC Number 019348928212. d. Model Number: DYNJ17624B, UPC Number: 019348986729; Model Number: DYNJ44320F, UPC Number 019348943551. e. Model Number: DYNJ47951A, UPC Number: 019348960984. f. Model Number: DYNJ40632C, UPC Number: 019348946117. g. Model Number: DYNJ30141, UPC Number: 019348956435; Model Number: DYNJ34361, UPC Number 088438934847; Model Number: DYNJ42903B, UPC Number: 088827779801; Model Number: DYNJ43661B, UPC Number 088994280870; Model Number: DYNJ47226A, UPC Number: 088827756181; Model Number: DYNJ50624A, UPC Number 088994247463; Model Number: DYNJ51239A, UPC Number: 088994249354; Model Number: DYNJ58111C, UPC Number 019348984600; Model Number: DYNJ58126A, UPC Number: 019348948475; Model Number: DYNJ62299, UPC Number 019348964151; Model Number: DYNJ62544, UPC Number: 019348966652; Model Number: DYNJ65043A, UPC Number 019348937932; Model Number: DYNJ66398A, UPC Number: 019348941416; Model Number: DYNJ66398B, UPC Number 019348989192. h. Model Number: DYNJ60507A, UPC Number: 019348983055. i. Model Number: DYNJ0373279L, UPC Number: 019348956435; Model Number: DYNJ0373279M, UPC Number: 019348951902. j. Model Number: DYNJ46153A, UPC Number: 088994218586; Model Number: DYNJ46153B, UPC Number: 019348985364; Model Number: DYNJ52121, UPC Number: 088994224362. k. Model Number: DYNJ62742, UPC Number: 019348968592, Lot Numbers: 21LBP049, 22OBH570, 22EBP081, 22FBG069, 20XBB252, 21BBH070, 21DBJ756. l. Model Number: DYNJ36049, UPC Number: 019348956435. m. Model Number: DYNJ0149444M, UPC Number: 019348956435. n. Model Number: DYNJ45007, UPC Number: 088827708541; Model Number: DYNJ47004C, UPC Number: 019348969617; Model Number: DYNJ66244, UPC Number: 019348932371. o. Model Number: DYNJ33638K, UPC Number: 019348934328. p. Model Number: DYNJ49621B, UPC Number: 088994228223; Model Number: DYNJ63060A, UPC Number: 019348942308; Model Number: DYNJ63684F, UPC Number: 019348989720; Model Number: DYNJ68065, UPC Number: 019348947511; Model Number: DYNJ68065A, UPC Number: 019348988872; Model Number: DYNJT2344B, UPC Number: 088994210780. q. Model Number: DYNJ28067G, UPC Number: 088994274429; Model Number: DYNJVB1135A, UPC Number: 019348933993. r. Model Number: 00-401318L, UPC Number: 088827709176; Model Number: 00-401318M, UPC Number: 019348934875. s. Model Number: CDS984944C, UPC Number: 088994217295. t. Model Number: DYNJ44293D, UPC Number: 019348983341; Model Number: DYNJ47906, UPC Number: 088827752837; Model Number: DYNJ55252B, UPC Number: 019348987015; Model Number: DYNJ57498, UPC Number: 088994274574; Model Number: DYNJ65190C, UPC Number: 019348943311; Model Number: DYNJ66476, UPC Number: 019348935677; Model Number: DYNJC2371G, UPC Number: 088994249467. u. Model Number: DYNJ0854485T, UPC Number: 019348986419. v. Model Number: DYNJ43203F, UPC Number: 019348939286; Model Number: DYNJ64655A, UPC Number: 019348986331. w. Model Number: DYNJ65185, UPC Number: 019348925314. x. Model Number: DYNJ62379, UPC Number: 019348965170. y. Model Number: DYNJ41649F, UPC Number: 019348964127. z. Model Number: DYNJ42367A, UPC Number: 088827794377. aa. Model Number: DYNJ33457C, UPC Number: 019348946180. bb. Model Number: DYNJ68758, UPC Number: 019348983756. cc. Model Number: DYNJ63527, UPC Number: 019348974839. dd. Model Number: DYNJ62379, UPC Number: 019348965170. ee. Model Number: DYNJ19939M, UPC Number: 019348939324. ff. Model Number: DYNJ49931F, UPC Number: 019348947166. gg. Model Number: DYNJ906354C, UPC Number: 019348981670. hh. Model Number: DYNJ24225K, UPC Number: 088994251070. ii. Model Number: DYNJ61015B, UPC Number: 019348936888. jj. Model Number: DYNJ42499C, UPC Number: 019532703086. kk. Model Number: DYNJ57760B, UPC Number: 019348934258. ll. Model Number: DYNJ59465B, UPC Number: 019348947093. mm. Model Number: DYNJ0806254D, UPC Number: 088994247116. nn. Model Number: DYNJ37665B, UPC Number: 088994296973. oo. Model Number: WK100B, UPC Number: 019348934875. pp. Model Number: DYNJ49884B, UPC Number: 088994236366; Model Number: DYNJ49884F, UPC Number: 019348946957. qq. Model Number: DYNJ41553D, UPC Number: 088994281133. rr. Model Number: DYNJ60319A, UPC Number: 019348927629. ss. Model Number: DYNJ67245, UPC Number: 019348939305. tt. Model Number: DYNJ65482A, UPC Number: 019348941682. uu. Model Number: PHS41743D, UPC Number: 019348945327. vv. Model Number: DYNJ54755D, UPC Number: 019348943426; Model Number: DYNJ54755F, UPC Number: 019348988460. ww. Model Number: DYNJ60112, UPC Number: 088827779984. xx. Model Number: DYNJ57645A, UPC Number: 019348955794; Model Number: DYNJ57645B, UPC Number: 019348982865. yy. Model Number: DYNJ61747A, UPC Number: 019348971965. zz. Model Number: DYNJ64830, UPC Number: 019348922313. aaa. Model Number: DYNJ66500, UPC Number: 019348935791. bbb. Model Number: DYNJ0201109AG, UPC Number: 019348949726.

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

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