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-2295-2023
- 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
- Hip & Knee Implants
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. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367B; e. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739; f. NERVE BLOCK ACCESSORY PACK, Model Number: DYNJ0134147D; g. NERVE BLOCK PREP TRAY, Model Numbers: DYNJRA1220, DYNJRA1571; h. NERVE BLOCK SUPPORT TRAY, Model Number: DYNJRA1109A; i. NERVE BLOCK TRAY, Model Numbers: DYNJRA0656A, DYNJRA1287A, DYNJRA1604; j. NERVE BLOCK TRAY/PREFERRED, Model Number: DYNJRA0725; k. PK, RADIOLOGY-NEURO-IR, Model Number: DYNJ51107B; l. SINGLE SHOT NERVE BLOCK TRAY, Model Number: DYNJRA1773; m. ULTRASOUND BLOCK PREP TRAY, Model Number: PAIN1622A; n. UNIVERSAL BLOCK TRAY/2, Model Number: DYNJRA1635A;
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: DYNJ33638J, UPC Number: 019348956435. b. Model Number: DYNJRA1543, UPC Number: 019348921766. c. Model Number: DYNJRA1247, UPC Number: 019348950391. d. Model Number: DYNJ42367B, UPC Number: 019348921151. e. Model Number: DYNJRA1739, UPC Number: 019348926312. f. Model Number: DYNJ0134147D, UPC Number: 088994293734. g. Model Number: DYNJRA1220, UPC Number: 088827779503; Model Number: DYNJRA1571, UPC Number 019348926473. h. Model Number: DYNJRA1109A, UPC Number: 019348925132. i. Model Number: DYNJRA0656A, UPC Number: 088994222511; Model Number: DYNJRA1287A, UPC Number: 019348977309; Model Number: DYNJRA1604, UPC Number 019348929981. j. Model Number: DYNJRA0725, UPC Number: 019348926312. k. Model Number: DYNJ51107B, UPC Number: 019348981047. l. Model Number: DYNJRA1773, UPC Number: 019348986297. m. Model Number: PAIN1622A, UPC Number: 019348989169. n. Model Number: DYNJRA1635A, UPC Number: 019348936764.
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
All 792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Device | CLASS I | Medline ReNewal Reprocessed St. Jude Medical Response recalled | Medline Industries LP - Northfield | Particulate Matter | Nationwide |
| 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 |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |