Recall Z-2232-2026
Medline Industries, LP · initiated April 10, 2026
Class I – dangerous or defective products that could cause serious health problems or death
Product
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN TRAY, Medline Kit SKU DYNJRA1555; 2) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA1817; 3) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA1920; 4) ULTRASOUND GUIDED NERVE BLOCK, Medline Kit SKU DYNJRA2013; 5) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2017; 6) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2067; 7) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2067A; 8) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2093; 9) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2117A; 10) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2124; 11) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2124A; 12) PAIN TRAY, Medline Kit SKU DYNJRA2144; 13) TRAY, 24G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2221; 14) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2333; 15) SPINAL TRAY, Medline Kit SKU DYNJRA2390; 16) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2402; 17) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407; 18) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407A; 19) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407B; 20) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2447; 21) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2447A; 22) SPINAL TRAY 25G, Medline Kit SKU DYNJRA2488A; 23) J&S SPINAL TRAY, Medline Kit SKU DYNJRA2545; 24) SPINAL TRAY, Medline Kit SKU DYNJRA2549; 25) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2550; 26) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2552; 27) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2554; 28) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2554A; 29) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2578; 30) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2588; 31) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2602; 32) SPINAL TRAY, Medline Kit SKU DYNJRA2618; 33) SPINAL TRAY, Medline Kit SKU DYNJRA2619; 34) SPINAL TRAY, Medline Kit SKU DYNJRA2622; 35) SPINAL BLOCK 25 WHITACRE 5S ND, Medline Kit SKU DYNJRA2624; 36) SPINAL TRAY, Medline Kit SKU DYNJRA2631; 37) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2632; 38) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2633; 39) SPINAL TRAY, Medline Kit SKU DYNJRA2645; 40) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2654; 41) CSE PAIN MANAGEMENT TRAY, Medline Kit SKU DYNJRA2665; 42) SPINAL TRAY, Medline Kit SKU DYNJRA2667; 43) SPINAL TRAY 24G BD, Medline Kit SKU DYNJRA2675; 44) SPINAL TRAY W/ CHLORAPREP, Medline Kit SKU DYNJRA2680; 45) SPINAL TRAY, Medline Kit SKU DYNJRA2682; 46) TRAY, 24G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2684; 47) SPINAL TRAY, Medline Kit SKU DYNJRA2725; 48) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2757; 49) TRAY, 25G SPINAL W/RX DURAPREP, Medline Kit SKU DYNJRA9039; 50) TRAY, 25G SPINAL W/RX, Medline Kit SKU DYNJRA9045; 51) SLSYSTEM CSE TRAY, Medline Kit SKU PAIN2333; 52) 25G SPINAL BLOCK TRAY, Medline Kit SKU SAMPA0135.
Codes / lots: Medline SKU DYNJRA1555: UDI/DI 10193489238723 each, 40193489238724 case, Lot Numbers: 25CLA724; Medline SKU DYNJRA1555: UDI/DI 10193489238723 each, 40193489238724 case, Lot Numbers: 25CLA306; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25JMH667; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25JMC856; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25JMA370; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25IMI402; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25HME985; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25AMI063; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 24JMI488; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 24JMA113; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 23KMD776; Medline SKU DYNJRA1920: UDI/DI 10195327111168 each, 40195327111169 case, Lot Numbers: 25FBQ144; Medline SKU DYNJRA2013: UDI/DI 10195327212049…
Reason for recall
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
FDA-determined cause: Component design/selection
Action taken
Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 4/10/2026 via USPS first class mail and email. The notice explained the issue with the component and requested the following: - Identify and quarantine the affected item and lot numbers (kit). - Respond to notice via the portal: Website link: https://recalls.medline.com, Recall Reference #: R-26-065-FGX1, using the Recall Code provided. - Once the response is received, over-labels will be provided to be placed on the affected inventory with instructions to remove and discard the affected component. - Distributors or those who have further distributed the product are directed to notify those to whom the affected kits were distributed and include the customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Details
- Recall number
- Z-2232-2026
- Initiated
- April 10, 2026
- Posted by FDA
- May 28, 2026
- Product code
- OFT – Spinal Epidural Anesthesia Kit
- Quantity
- 28106 kits
- Distribution
- Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2231-2026 Class I | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled…Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which… | 04/10/2026Open, Classified |
| Z-2233-2026 Class I | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled…Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which… | 04/10/2026Open, Classified |
| Z-2234-2026 Class I | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled…Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which… | 04/10/2026Open, Classified |
| Z-2235-2026 Class I | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled…Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which… | 04/10/2026Open, Classified |
| Z-2236-2026 Class I | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled…Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which… | 04/10/2026Open, Classified |
| Z-2237-2026 Class I | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled…Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which… | 04/10/2026Open, Classified |