Recall archive / FDA device enforcement

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOG... — FDA record Z-2338-2023

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. ANGIOGRAPHY PACK, Model Number: DYNJ65963A; b. ARTHOGRAM TRAY, Model Number: PAIN1524B; c. ARTHROGRAM TRAY, Model Number: PAIN1524A; d. CARPAL TUNNEL KIT, Model Number: DYNJ63149A; e. CRANIOTOMY CDS, Model Number: CDS981753L; f. CRANIOTOMY CDS-1, Model Number: CDS982889I; g. CRANIOTOMY PACK, Model Number: DYNJ61749A; h. DBD-JOINT INJECTION TRAY, Model Number: DYNDH1722; i. ENS STERILE POUR IMPLANT-LF, Model Number: OST011E; j. FREE FLAP LOWER EXT-LF, Model Number: DYNJ909168; k. FREE FLAP UPPER EXT-LF, Model Number: DYNJ909169; l. HYBRID PACK, Model Number: DYNJ56907D; m. IR ARM PACK, Model Number: DYNJ50712C; n. LOWER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0204D; o. MURRIETA PACK, Model Number: DYNJ69312, DYNJ69312A; p. OASC IVF PACK, Model Number: DYNJ53035B; q. PERIPHERAL NERVE BLOCK KIT, Model Number: DYNJRA1619; r. RO VASCULAR EXTREMITY PK-LF, Model Number: PHS392881009C; s. SCO ARTHROSCOPY, Model Number: DYNJ906551A; t. SHOULDER BLOCK KIT , Model Number: DYKS1241A; u. SHOULDER PACK-LF, Model Number: PHS41748D; v. TAA AAA, Model Number: DYNJ63339D; w. TOTAL HIP PACK-LF, Model Number: DYNJ51672J, DYNJ51672K, DYNJ51672L; x. TOTAL KNEE REPLACEMENT, Model Number: DYNJ908420; y. TUNNEL PACK, Model Number: DYNJ58127B; z. UPPER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0205F; aa. US JOINT KIT, Model Number: DYNJRA1944; bb. VASCULAR EXTREMITY PACK, Model Number: DYNJ63373B, DYNJ63373C, DYNJ63373D, DYNJ63373F;
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: 15,323 kits
Agency-reported status: Ongoing
Source record identifier: Z-2338-2023

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: DYNJ65963A, UPC Number: 019348999205. b. Model Number: PAIN1524B, UPC Number: 019348999446. c. Model Number: PAIN1524A, UPC Number: 019348932800. d. Model Number: DYNJ63149A, UPC Number: 019348978647. e. Model Number: CDS981753L, UPC Number: 019532723862. f. Model Number: CDS982889I, UPC Number: 088994220806. g. Model Number: DYNJ61749A, UPC Number: 019532706301. h. Model Number: DYNDH1722, UPC Number: 019532713216. i. Model Number: OST011E, UPC Number: 088827758932. j. Model Number: DYNJ909168, UPC Number: 019532728659. k. Model Number: DYNJ909169, UPC Number: 019532728660. l. Model Number: DYNJ56907D, UPC Number: 019348983156. m. Model Number: DYNJ50712C, UPC Number: 019348987016. n. Model Number: SPEC0204D, UPC Number: 019348930298. o. Model Number: DYNJ69312, UPC Number: 019348992946; Model Number: DYNJ69312A, UPC Number: 019532721677. p. Model Number: DYNJ53035B, UPC Number: 088827776381. q. Model Number: DYNJRA1619, UPC Number: 019348931184. r. Model Number: PHS392881009C, UPC Number: 019348922233. s. Model Number: DYNJ906551A, UPC Number: 019532712408. t. Model Number: DYKS1241A, UPC Number: 019348948809. u. Model Number: PHS41748D, UPC Number: 019348978479. v. Model Number: DYNJ63339D, UPC Number: 019532727360. w. Model Number: DYNJ51672J, UPC Number: 019348958962; Model Number: DYNJ51672K, UPC Number: 019532711224; Model Number: DYNJ51672L, UPC Number: 019532722130. x. Model Number: DYNJ908420, UPC Number: 019532707336. y. Model Number: DYNJ58127B, UPC Number: 019348948279. z. Model Number: SPEC0205F, UPC Number: 019348921288. aa. Model Number: DYNJRA1944, UPC Number: 019532713304. bb. Model Number: DYNJ63373B, UPC Number: 019348929206; Model Number: DYNJ63373C, UPC Number: 019348995812; Model Number: DYNJ63373D, UPC Number: 019532708615; Model Number: DYNJ63373F, UPC Number: 019532727078.

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: DYNJ65963A, UPC Number: 019348999205. b. Model Number: PAIN1524B, UPC Number: 019348999446. c. Model Number: PAIN1524A, UPC Number: 019348932800. d. Model Number: DYNJ63149A, UPC Number: 019348978647. e. Model Number: CDS981753L, UPC Number: 019532723862. f. Model Number: CDS982889I, UPC Number: 088994220806. g. Model Number: DYNJ61749A, UPC Number: 019532706301. h. Model Number: DYNDH1722, UPC Number: 019532713216. i. Model Number: OST011E, UPC Number: 088827758932. j. Model Number: DYNJ909168, UPC Number: 019532728659. k. Model Number: DYNJ909169, UPC Number: 019532728660. l. Model Number: DYNJ56907D, UPC Number: 019348983156. m. Model Number: DYNJ50712C, UPC Number: 019348987016. n. Model Number: SPEC0204D, UPC Number: 019348930298. o. Model Number: DYNJ69312, UPC Number: 019348992946; Model Number: DYNJ69312A, UPC Number: 019532721677. p. Model Number: DYNJ53035B, UPC Number: 088827776381. q. Model Number: DYNJRA1619, UPC Number: 019348931184. r. Model Number: PHS392881009C, UPC Number: 019348922233. s. Model Number: DYNJ906551A, UPC Number: 019532712408. t. Model Number: DYKS1241A, UPC Number: 019348948809. u. Model Number: PHS41748D, UPC Number: 019348978479. v. Model Number: DYNJ63339D, UPC Number: 019532727360. w. Model Number: DYNJ51672J, UPC Number: 019348958962; Model Number: DYNJ51672K, UPC Number: 019532711224; Model Number: DYNJ51672L, UPC Number: 019532722130. x. Model Number: DYNJ908420, UPC Number: 019532707336. y. Model Number: DYNJ58127B, UPC Number: 019348948279. z. Model Number: SPEC0205F, UPC Number: 019348921288. aa. Model Number: DYNJRA1944, UPC Number: 019532713304. bb. Model Number: DYNJ63373B, UPC Number: 019348929206; Model Number: DYNJ63373C, UPC Number: 019348995812; Model Number: DYNJ63373D, UPC Number: 019532708615; Model Number: DYNJ63373F, UPC Number: 019532727078.

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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