Recall Z-2534-2026
Medline Industries, LP · initiated May 21, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317; 3) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1579A; 4) CSE TRAY, Model Number: PAIN1885A; 5) REINFORCED CATH EPIDURAL TRAY, Model Number: PAIN1967A; 6) TRAY,CON EPID,19G REINF OPNTIP, Model Number: PAIN2269; 7) EPIDURAL TRAY, Model Number: PAIN2278; 8) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN2305; 9) CSE TRAY MEDLINE, Model Number: PAIN2334; 10) PNBT TRAY, Model Number: SAMPA0147
Codes / lots: 1) PAIN0072L, UDI-DI: 10198459544163(each), 40198459544164(case), Lot Number: 25JDB100; 2) PAIN1317, UDI-DI: 10888277797109(each), 40888277797100(case), Lot Number: 25JLA788; 3) PAIN1579A, UDI-DI: 10193489422443(each), 40193489422444(case), Lot Number: 25JLA779; 4) PAIN1885A, UDI-DI: 10195327486310(each), 40195327486311(case), Lot Number: 25JLA861; 5) PAIN1967A, UDI-DI: 10198459241215(each), 40198459241216(case), Lot Number: 25JLA659; 6) PAIN2269, UDI-DI: 10198459342004(each), 40198459342005(case), Lot Number: 25JLA781; 7) PAIN2278, UDI-DI: 10198459376177(each), 40198459376178(case), Lot Number: 25JLA886; 8) PAIN2305, UDI-DI: 10198459478819(each), 40198459478810(case), Lot Number: 25JLA601; 9) PAIN2334, UDI-DI: 10198459540639(each), 40198459540630(case), Lot Number: 25JLA942; 10) SAMPA0147, UDI-DI: 10198459552809(each), 40198459552800(case), Lot Number: 25JLA928;
Reason for recall
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
FDA-determined cause: Nonconforming Material/Component
Action taken
An URGENT MEDICAL DEVICE RECALL notification letter dated 5/21/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-082-FGX2 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your 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. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Details
- Recall number
- Z-2534-2026
- Initiated
- May 21, 2026
- Posted by FDA
- June 29, 2026
- Product code
- OFT – Spinal Epidural Anesthesia Kit
- Quantity
- 1,512 kits
- Distribution
- US Nationwide distribution.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2533-2026 Class II | Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2)…The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | 05/21/2026Open, Classified |
| Z-2535-2026 Class II | Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | 05/21/2026Open, Classified |
| Z-2536-2026 Class II | Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number:…The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | 05/21/2026Open, Classified |
| Z-2537-2026 Class II | Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2)…The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | 05/21/2026Open, Classified |
| Z-2538-2026 Class II | Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C…The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | 05/21/2026Open, Classified |
| Z-2539-2026 Class II | Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST…The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | 05/21/2026Open, Classified |
| Z-2540-2026 Class II | Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | 05/21/2026Open, Classified |
| Z-2541-2026 Class II | Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO…The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | 05/21/2026Open, Classified |
| Z-2542-2026 Class II | Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE…The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | 05/21/2026Open, Classified |
| Z-2543-2026 Class II | Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND…The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | 05/21/2026Open, Classified |
| Z-2544-2026 Class II | Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | 05/21/2026Open, Classified |
| Z-2545-2026 Class II | Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699AThe kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | 05/21/2026Open, Classified |
| Z-2546-2026 Class II | Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2)…The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | 05/21/2026Open, Classified |
| Z-2547-2026 Class II | Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922AThe kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | 05/21/2026Open, Classified |