CLASS II ONGOING Device recall · Reported 9 Aug 2023 · FDA Enforcement Report
Custom Sterile and Non-Sterile Procedural Kits recalled
Medline Industries LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel, distributed nationwide in the US. The recall was initiated on 15 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2317-2023
- FDA event ID
- 92399
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 May 2023
- FDA classified
- 3 Aug 2023
- Reported
- 9 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 15 May 2023 | Recall initiated by company | |
| 3 Aug 2023 | Classified by FDA | +80 days |
| 9 Aug 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (54) KIT STC PLASTIC FREE FLAP, Model Number: DYNJ909031; b. BREAST, Model Number: DYNJ904598B; c. BREAST DBL PROCED SUPPLEMENT, Model Number: DYNJ63893; d. BREAST PACK, Model Number: DYNDH1306; e. BRST BX TRAY, Model Number: DYNDH1389B; f. CMC BREAST BIOPSY TRAY-LF, Model Number: DYNJ61084A; g. DBD-DIEP PACK, Model Number: DYNJ60669F; h. DBD-FREE FLAP, Model Number: DYNJ907802; i. DBD-FREE FLAP PACK, Model Number: DYNJ83286; j. DBD-MAJOR BREAST, Model Number: DYNJ905004B; k. DBD-PLASTICS FREE FLAP, Model Number: SYNJ910024A; l. DELNOR SIMPLE PLASTIC PACK, Model Number: DYNJ82250; m. DIEP, Model Number: DYNJ905702C, DYNJ905702D; n. DIEP FLAP CDS, Model Number: DYNJ904762D; o. DIEP PACK, Model Number: DYNJ60669C, DYNJ60669D; p. FH BREAST FLAP PACK, Model Number: DYNJ58272C, DYNJ58272D; q. FLAP KIT, Model Number: DYNJ900845B; r. FLAP PACK, Model Number: DYNJ48191G, DYNJ48191I, DYNJ48191J, DYNJ60224B; s. FLAP RECONSTRUCTION PACK-LF, Model Number: DYNJ0378388P; t. FREE FLAP, Model Number: DYNJ906823A, DYNJ906823B; u. FREE FLAP 1 PACK, Model Number: DYNJ82660; v. FREE FLAP 2 PACK, Model Number: DYNJ82659; w. FREE FLAP BASIC SET-UP PK, Model Number: DYNJ0991320L; x. FREE FLAP CDS, Model Number: CDS983996B; y. FREE FLAP CUSTOM PACK B, Model Number: DYNJ82736; z. FREE FLAP DONOR, Model Number: DYNJ44483B; aa. FREE FLAP PACK, Model Number: DYNJ83286; bb. FREE FLAP PACK-LF, Model Number: DYNJ0271254O, DYNJ20495I, DYNJ42833A, DYNJ42833B, PHS656679003; cc. FREE FLAP RECIPIENT, Model Number: DYNJ44484D, DYNJ44484F; dd. MAIN FLAP, Model Number: DYNJ908264; ee. MAJOR BREAST, Model Number: DYNJ905004A, DYNJ908890; ff. MINOR BREAST, Model Number: DYNJ905002B, DYNJ908892; gg. PK GEN BREAST RESTON, Model Number: DYNJ84305; hh. PLASTIC DIEP PACK, Model Number: DYNJ81727, DYNJ81727A; ii. PLASTIC FREE FLAP, Model Number: DYNJ67367, DYNJ67367A; jj. PLASTIC FREE FLAP PACK, Model Number: DYNJ82758; kk. PLASTIC MICROVASCULAR, Model Number: DYNJ908181, DYNJ908181A, DYNJ908181B; ll. PLASTIC PACK, Model Number: DYNJ35262A; mm. PROCEDURE PACK, Model Number: DYNJ55063; nn. RO-DIEP PACK, Model Number: DYNJ82393; oo. SDS MN BREAST PACK, Model Number: DYNJ57719C, DYNJ57719D; pp. VNUS RFS PROCEDURE PACK, Model Number: DYNJ39508A;
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Questions about this recall
Why was it recalled?
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Which lots are affected?
All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ909031, UPC Number: 019532725061. b. Model Number: DYNJ904598B, UPC Number: 088994294635. c. Model Number: DYNJ63893, UPC Number: 019348977156. d. Model Number: DYNDH1306, UPC Number: 088994277152. e. Model Number: DYNDH1389B, UPC Number: 019348944918. f. Model Number: DYNJ61084A, UPC Number: 019348969202. g. Model Number: DYNJ60669F, UPC Number: 019532728956. h. Model Number: DYNJ907802, UPC Number: 019348989000. i. Model Number: DYNJ83286, UPC Number: 019532725665. j. Model Number: DYNJ905004B, UPC Number: 019348978258. k. Model Number: SYNJ910024A, UPC Number: 019348937448. l. Model Number: DYNJ82250, UPC Number: 019532718175. m. Model Number: DYNJ905702C, UPC Number: 019532700467; Model Number: DYNJ905702D, UPC Number: 019532717382. n. Model Number: DYNJ904762D, UPC Number: 019532725881. o. Model Number: DYNJ60669C, UPC Number: 019532702362; Model Number: DYNJ60669D, UPC Number: 019532721717. p. Model Number: DYNJ58272C, UPC Number: 019348989552; Model Number: DYNJ58272D, UPC Number: 019532714511. q. Model Number: DYNJ900845B, UPC Number: 088994263442. r. Model Number: DYNJ48191G, UPC Number: 019348947660; Model Number: DYNJ48191I, UPC Number: 019532705781; Model Number: DYNJ48191J, UPC Number: 019532725503; Model Number: DYNJ60224B, UPC Number: 019348987735. s. Model Number: DYNJ0378388P, UPC Number: 019532708997. t. Model Number: DYNJ906823A, UPC Number: 019348989447; Model Number: DYNJ906823B, UPC Number: 019532702707. u. Model Number: DYNJ82660, UPC Number: 019532719933. v. Model Number: DYNJ82659, UPC Number: 019532719932. w. Model Number: DYNJ0991320L, UPC Number: 019532702854. x. Model Number: CDS983996B, UPC Number: 088994213130. y. Model Number: DYNJ82736, UPC Number: 019532720755. z. Model Number: DYNJ44483B, UPC Number: 088994281894. aa. Model Number: DYNJ83286, UPC Number: 019532725665. bb. Model Number: DYNJ0271254O, UPC Number: 019348956435; Model Number: DYNJ20495I, UPC Number: 019348956435; Model Number: DYNJ42833A, UPC Number: 088827750399; Model Number: DYNJ42833B, UPC Number: 019348988033; Model Number: PHS656679003, UPC Number: 088994204000. cc. Model Number: DYNJ44484D, UPC Number: 088994281895; Model Number: DYNJ44484F, UPC Number: 019348948834. dd. Model Number: DYNJ908264, UPC Number: 019532702011. ee. Model Number: DYNJ905004A, UPC Number: 088994291171, Model Number: DYNJ908890, UPC Number: 019532720339. ff. Model Number: DYNJ905002B, UPC Number: 019532731686, Model Number: DYNJ908892, UPC Number: 019532720403. gg. Model Number: DYNJ84305, UPC Number: 019532734981. hh. Model Number: DYNJ81727, UPC Number: 019532713711; Model Number: DYNJ81727A, UPC Number: 019532727789. ii. Model Number: DYNJ67367, UPC Number: 019348989571; Model Number: DYNJ67367A, UPC Number: 019532723070. jj. Model Number: DYNJ82758, UPC Number: 019532720744. kk. Model Number: DYNJ908181, UPC Number: 019532700174; Model Number: DYNJ908181A, UPC Number: 019532706226; Model Number: DYNJ908181B, UPC Number: 019532724293. ll. Model Number: DYNJ35262A, UPC Number: 019348990343. mm. Model Number: DYNJ55063, UPC Number: 088994252657. nn. Model Number: DYNJ82393, UPC Number: 019532718973. oo. Model Number: DYNJ57719C, UPC Number: 019348976734; Model Number: DYNJ57719D, UPC Number: 019348994582. pp. Model Number: DYNJ39508A, UPC Number: 088994262891.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
49 other products · FDA event 92399This product is part of a recall event; the main page for the event is Custom Sterile and Non-Sterile Procedural Kits recalled.
More recalls from Medline Industries LP - Northfield
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|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
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| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
| Device | CLASS II | Medline Kits containing BD SureStep Foley Tray Systems recalled | Medline Industries LP - Northfield | Labeling Errors | FL, IL |
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |