Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the...
FDA Device Recall #Z-2320-2023 — Class II — May 15, 2023
Recall Summary
| Recall Number | Z-2320-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 15, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 93,587 kits |
Product Description
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. ROSEN VEIN PACK, Model Number: DYNJ67517; b. DR. VANBOSSE LOWER EXT PACK, Model Number: DYNJ51416B; c. DRAINAGE TRAY, Model Number: DYNJ42913, DYNJ42913A; d. ECMO PACK, Model Number: DYNJ61243; e. EGG RETRIEVAL PACK, Model Number: DYNJ66291, DYNJ66291A; f. EH TAVR PACK, Model Number: DYNJ57449A; g. ELVS PACK-LF, Model Number: DYNJ26940G; h. ENDO AAA HYBRID CHRG, Model Number: DYNJ60126; i. ENDOVASCULAR OR PACK, Model Number: DYNJ54265; j. ENDOVASCULAR PACK, Model Number: DYNJ59085; k. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831D; l. ENDOVENOUS ABLATION PACK, Model Number: DYNJ53435C; m. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456B; n. ENDOVENOUS CORE PACK, Model Number: DYNJ59168; o. ENDOVENOUS PACK, Model Number: DYNJ58228; p. ENS BIOPSIE THYROIDE-HEJ-LF, Model Number: DYNJ62443; q. EP LAB, Model Number: DYNJ59392C; r. EP MERCY JANESVILLE, Model Number: DYNJ907013; s. EP PACK, Model Number: DYNJ57594A; t. EVAR, Model Number: DYNJ900005L; u. EVLA PACK, Model Number: DYNJ66258; v. EVLT, Model Number: DYNJ62417, DYNJ64336; w. EVLT CORE PACK, Model Number: DYNJ45294; x. EVLT PACK, Model Number: DYNJ38674A, DYNJ45997C, DYNJ56548B, DYNJ65995, DYNJ65995A, DYNJ66005; y. FEM POP PACK, Model Number: DYNJ01964M, DYNJ67487A; z. FETAL OPEN/EXIT, Model Number: DYNJ904069C; aa. FH THORACIC PACK, Model Number: DYNJ58572B, DYNJ58572C; bb. FISTULAGRAM/C-ACCESS PACK, Model Number: DYNJ59657A; cc. FLAP, Model Number: DYNJ905146A; dd. FREE FLAP PACK CTX, Model Number: DYNJ68380C; ee. FREE FLAP PACK-LF, Model Number: DYNJ0271254P; ff. FREE FLAP TRAM ADD ON PACK, Model Number: DYNJ82179; gg. GEL ULTRASOUND 20G FOIL , Model Number: DYNJZ45357; hh. GENERAL USE PACK, Model Number: DYNJ41137B; ii. GU ROBOTIC PACK-LF, Model Number: DYNJ0972464Y; jj. GYN LITHOTOMY, Model Number: DYNJ906579C; kk. HH VARITHENA VEIN PACK, Model Number: DYNJ59500; ll. HH VEIN CLOSURE PACK, Model Number: DYNJ59501; mm. HH VEIN PICC MADISON PACK, Model Number: DYNJ59508; nn. HILLCREST PCNL PACK, Model Number: DYNJ69204B; oo. HL VEIN STRIPPING PACK, Model Number: DYNJ40374A; pp. HYBRID KIT, Model Number: DYNJ905335; qq. HYBRID OR PACK, Model Number: SYNJ10303B; rr. I.R. PACK, Model Number: DYNJ60343A; ss. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708F; tt. IR MINI KIT, Model Number: DYNJ44519F; uu. IR NEURO PACK, Model Number: DYNJ39198I; vv. IR PERIPHERAL PACK, Model Number: DYNJ45033A; ww. IR SONO PACK, Model Number: DYNDA2365, DYNDA2365B; xx. JBMH EVAR PACK, Model Number: DYNJ69820; yy. JOHNSON OH ACCESSORY PACK, Model Number: DYNJ51927A; zz. JUDKINS PACK-LF, Model Number: DYNJ0530948AR, DYNJ0586030P; aaa. JVL-PACK TUNNELED, Model Number: DYNJ66065; bbb. KF PACK, Model Number: DYNJ57547, DYNJ58647, DYNJ60127A; ccc. KF PACK 2.0, Model Number: DYNJ69619; ddd. KIDNEY CDS, Model Number: DYNJ903873C; eee. KIDNEY TRANSPLANT, Model Number: DYNJ905682; fff. KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173B; ggg. KIT LB OPEN HEART, Model Number: DYNJ902261D, DYNJ904401B; hhh. KT TAVR PACK, Model Number: DYNJ56283B; iii. LARGE PROCEDURE PACK, Model Number: DYNJ35524D; jjj. LASER ABLATION, Model Number: DYNJ80299; kkk. LASER KIT, Model Number: DYNJ64075A; lll. LASER PACK, Model Number: DYNJ39053A; mmm. LINE KIT, Model Number: DYNJ47987B; nnn. LINE PLACEMENT PACK-LF, Model Number: DYNJ0931376F; ooo. LIVER 2018, Model Number: DYNJ905655, DYNJ905655B; ppp. LIVER TRANSPLANT CDS, Model Number: CDS984951D; qqq. LIVER TRANSPLANT PACK, Model Number: DYNJ0271349T; rrr. LONESTAR RF PACK, Model Number: DYNJ83152; sss. MAD PERIPHERAL VASCULAR-LF, Model Number: DYNJ902168D; ttt. MAG FREE FLAP CDS-LF,
Reason for Recall
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Lot / Code Information
All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ67517, UPC Number: 019348940782. b. Model Number: DYNJ51416B, UPC Number: 088827774647. c. Model Number: DYNJ42913, UPC Number: 088827701320; Model Number: DYNJ42913A, UPC Number: 019532708060. d. Model Number: DYNJ61243, UPC Number: 019348955091. e. Model Number: DYNJ66291, UPC Number: 019348932808, Model Number: DYNJ66291A, UPC Number: 019348948000. f. Model Number: DYNJ57449A, UPC Number: 088994282753. g. Model Number: DYNJ26940G, UPC Number: 019348954079. h. Model Number: DYNJ60126, UPC Number: 088994295193. i. Model Number: DYNJ54265, UPC Number: 088994247400. j. Model Number: DYNJ59085, UPC Number: 088994293201. k. Model Number: DYNJ42831D, UPC Number: 088994284953. l. Model Number: DYNJ53435C, UPC Number: 019348920086. m. Model Number: DYNJ48456B, UPC Number: 088994273317. n. Model Number: DYNJ59168, UPC Number: 088827776444. o. Model Number: DYNJ58228, UPC Number: 088994283549. p. Model Number: DYNJ62443, UPC Number: 019348967919. q. Model Number: DYNJ59392C, UPC Number: 019348928224. r. Model Number: DYNJ907013, UPC Number: 019348931863. s. Model Number: DYNJ57594A, UPC Number: 088994296321. t. Model Number: DYNJ900005L, UPC Number: 019348930031. u. Model Number: DYNJ66258, UPC Number: 019348932547. v. Model Number: DYNJ62417, UPC Number: 019348965705; Model Number: DYNJ64336, UPC Number: 019348980187. w. Model Number: DYNJ45294, UPC Number: 088827709897. x. Model Number: DYNJ38674A, UPC Number: 019348956435; Model Number: DYNJ45997C, UPC Number: 088994268436; Model Number: DYNJ56548B, UPC Number: 019348981318; Model Number: DYNJ65995, UPC Number: 019348931154; Model Number: DYNJ65995A, UPC Number: 019532706812; Model Number: DYNJ66005, UPC Number: 019348931254. y. Model Number: DYNJ01964M, UPC Number: 019348956435; Model Number: DYNJ67487A, UPC Number: 019348988899. z. Model Number: DYNJ904069C, UPC Number: 019348999549. aa. Model Number: DYNJ58572B, UPC Number: 019348989338; Model Number: DYNJ58572C, UPC Number: 019532714262. bb. Model Number: DYNJ59657A, UPC Number: 019348954461. cc. Model Number: DYNJ905146A, UPC Number: 019348956922. dd. Model Number: DYNJ68380C, UPC Number: 019532734124. ee. Model Number: DYNJ0271254P, UPC Number: 019532708953. ff. Model Number: DYNJ82179, UPC Number: 019532718266. gg. Model Number: DYNJZ45357, UPC Number: 088994237354. hh. Model Number: DYNJ41137B, UPC Number: 088994226087. ii. Model Number: DYNJ0972464Y, UPC Number: 019348978326. jj. Model Number: DYNJ906579C, UPC Number: 019532702356. kk. Model Number: DYNJ59500, UPC Number: 088827775013. ll. Model Number: DYNJ59501, UPC Number: 088827775014. mm. Model Number: DYNJ59508, UPC Number: 088827775130. nn. Model Number: DYNJ69204B, UPC Number: 019532736422. oo. Model Number: DYNJ40374A, UPC Number: 088827755794. pp. Model Number: DYNJ905335, UPC Number: 088994287589. qq. Model Number: SYNJ10303B, UPC Number: 019348937374. rr. Model Number: DYNJ60343A, UPC Number: 019348957383. ss. Model Number: DYNJ9048708F, UPC Number: 019348972521. tt. Model Number: DYNJ44519F, UPC Number: 019348946747. uu. Model Number: DYNJ39198I, UPC Number: 019348956435. vv. Model Number: DYNJ45033A, UPC Number: 019348947580. ww. Model Number: DYNDA2365, UPC Number: 019348951634; Model Number: DYNDA2365B, UPC Number: 019348983644. xx. Model Number: DYNJ69820, UPC Number: 019348998143. yy. Model Number: DYNJ51927A, UPC Number: 088827779416. zz. Model Number: DYNJ0530948AR, UPC Number: 019532714188; Model Number: DYNJ0586030P, UPC Number: 088994294714. aaa. Model Number: DYNJ66065, UPC Number: 019348931918. bbb. Model Number: DYNJ57547, UPC Number: 088994275104; Model Number: DYNJ58647, UPC Number: 088994287545; Model Number: DYNJ60127A, UPC Number: 019348972904. ccc. Model Number: DYNJ69619, UPC Number: 019348995944. ddd. Model Number: DYNJ903873C, UPC Number: 019348946309. eee. Model Number: DYNJ905682, UPC Number: 088827779190. fff. Model Number: DYKMBNDL173B, UPC Number: 019532724075. ggg. Model Number: DYNJ902261D, UPC Number: 088994275524; Model Number: DYNJ904401B, UPC Number: 019348968343. hhh. Model Number: DYNJ56283B, UPC Number: 019348969525. iii. Model Number: DYNJ35524D, UPC Number: 019348976610. jjj. Model Number: DYNJ80299, UPC Number: 019532702193. kkk. Model Number: DYNJ64075A, UPC Number: 019348923132. lll. Model Number: DYNJ39053A, UPC Number: 019348956435. mmm. Model Number: DYNJ47987B, UPC Number: 019348986737. nnn. Model Number: DYNJ0931376F, UPC Number: 019348927150. ooo. Model Number: DYNJ905655, UPC Number: 088827778885; Model Number: DYNJ905655B, UPC Number: 019532713015. ppp. Model Number: CDS984951D, UPC Number: 019348925779. qqq. Model Number: DYNJ0271349T, UPC Number: 019532708969. rrr. Model Number: DYNJ83152, UPC Number: 019532723708. sss. Model Number: DYNJ902168D, UPC Number: 019348986615. ttt. Model Number: CDS982911M, UPC Number: 019348946493. uuu. Model Number: DYNJ68172, UPC Number: 019348949239. vvv. Model Number: CDS980752I, UPC Number: 088994242854; Model Number: DYNJ54285A, UPC Number: 088994276548. www. Model Number: CDS983315G, UPC Number: 088994286443. xxx. Model Number: DYND2673B, UPC Number: 019348956435. yyy. Model Number: DYNJ51705B, UPC Number: 019348987717. zzz. Model Number: DYNJ0248546C, UPC Number: 088994205551; Model Number: DYNJ0248546D, UPC Number: 019532706928. aaaa. Model Number: CDS984379D, UPC Number: 088994272434. bbbb. Model Number: MID0001, UPC Number: 019348938162. cccc. Model Number: DYNJ80141MB, UPC Number: 088994273341. dddd. Model Number: PICC0009A, UPC Number: 088994214185. eeee. Model Number: DYNJ80152MB, UPC Number: 088994273342. ffff. Model Number: DYNJ905002A, UPC Number: 088994291165. gggg. Model Number: DYNJ64439, UPC Number: 019348920048. hhhh. Model Number: DYNJ38326F, UPC Number: 019348956435. iiii. Model Number: DYNJ902281, UPC Number: 088827798141. jjjj. Model Number: NG410A, UPC Number: 088994294588. kkkk. Model Number: DYNJ63892, UPC Number: 019348977143. llll. Model Number: DYNJ69716A, UPC Number: 019532725057. mmmm. Model Number: ARTNC115, UPC Number: 065316035433. nnnn. Model Number: DYNJ63739, UPC Number: 019348975467. oooo. Model Number: DYNJ59201B, UPC Number: 019348931026; Model Number: DYNJ59201C, UPC Number: 019532706202. pppp. Model Number: DYNJ908680, UPC Number: 019532713938. qqqq. Model Number: DYNJ61517, UPC Number: 019348957757. rrrr. Model Number: DYNJ82561, UPC Number: 019532719797. ssss. Model Number: DYNJ54569A, UPC Number: 019348974295. tttt. Model Number: DYNJ60126A, UPC Number: 019348924708. uuuu. Model Number: DYNJ65488B, UPC Number: 019348944364. vvvv. Model Number: DYNJ906902, UPC Number: 019348928093. wwww. Model Number: DYNJ906895C, UPC Number: 019532730355. xxxx. Model Number: DYNDH1165A, UPC Number: 088994261150, 10889942611508. yyyy. Model Number: DYNJ37280C, UPC Number: 088994243165; Model Number: DYNJ56536, UPC Number: 088994265471. zzzz. Model Number: DYNDH1292, UPC Number: 088994274223; Model Number: DYNDH1470B, UPC Number: 019348911124; Model Number: DYNDH1470C, UPC Number: 019532729771.
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.