Recall Z-2111-2026
Medline Industries, LP · initiated January 7, 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) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) D&C/HYSTEROSCOPY PACK, Model Number: DYNJ0547084O; 6) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 7) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 8) VAG HYST PACK, Model Number: DYNJ31344J; 9) VAG HYST PACK, Model Number: DYNJ31344K; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 12) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 13) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O; 14) LAVH PACK, Model Number: DYNJ36712F; 15) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I; 16) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C; 17) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I; 18) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B; 19) LAVH - N #668629 -N, Model Number: DYNJ58121C; 20) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B; 21) HYSTEROSCOPY PACK, Model Number: DYNJ59444G; 22) D AND C PACK, Model Number: DYNJ61282B; 23) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161; 24) PERI GYN, Model Number: DYNJ67708A; 25) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B; 26) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C; 27) ANORECTAL PACK, Model Number: DYNJ83560; 28) D&C CDS, Model Number: DYNJ902560I; 29) HYSTEROSCOPY, Model Number: DYNJ903327K; 30) HYSTEROSCOPY, Model Number: DYNJ903475I; 31) ROBOTIC HYST, Model Number: DYNJ903798G; 32) TLH KIT, Model Number: DYNJ908149; 33) LAVH TOTE, Model Number: DYNJ908340; 34) LAVH TOTE, Model Number: DYNJ908340A; 35) LAVH TOTE, Model Number: DYNJ908340B; 36) LAVH TOTE, Model Number: DYNJ908340D; 37) LAVH, Model Number: DYNJ908986; 38) LAVH, Model Number: DYNJ908986A; 39) BRECKENRIDGE LAVH, Model Number: DYNJ910537; 40) LAVH GYN/ONC, Model Number: DYNJ910927; 41) VAG HYST PACK, Model Number: DYNJT3348; 42) LAVH PART B, Model Number: DYNJV0312G
Codes / lots: 1) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23GBE705; 2) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23HBY878; 3) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23IBV204; 4) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 24ABO363; 5) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 24CBQ563; 6) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH028; 7) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH032; 8) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH451; 9) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23CBL440; 10) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23CBS135; 11) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23FBC116; 12) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23FBD256; 13) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23HBI773; 14) DYNJ0373807J, UDI-DI:…
Reason for recall
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA-determined cause: Process control
Action taken
An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 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-26-003-FGX1 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. An URGENT MEDICAL DEVICE RECALL notification letter dated 1/14/26 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-26-003-
Details
- Recall number
- Z-2111-2026
- Initiated
- January 7, 2026
- Posted by FDA
- May 7, 2026
- Product code
- OJF – Hysterectomy Kit
- Quantity
- 6676 units
- Distribution
- Worldwide - US Nationwide distribution.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2089-2026 Class II | Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2090-2026 Class II | Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2091-2026 Class II | Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2092-2026 Class II | Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2093-2026 Class II | See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2094-2026 Class II | Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2095-2026 Class II | Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2096-2026 Class II | Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2097-2026 Class II | See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2098-2026 Class II | See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2099-2026 Class II | See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2100-2026 Class II | Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2101-2026 Class II | See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2102-2026 Class II | Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2103-2026 Class II | Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2104-2026 Class II | Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945PMedline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2105-2026 Class II | Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343AMedline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2106-2026 Class II | Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2107-2026 Class II | Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2108-2026 Class II | Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2109-2026 Class II | See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number:…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2110-2026 Class II | Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2112-2026 Class II | Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2113-2026 Class II | Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2114-2026 Class II | See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number:…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2115-2026 Class II | Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2116-2026 Class II | Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150CMedline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2117-2026 Class II | Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2118-2026 Class II | Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-2119-2026 Class II | Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806LMedline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |