UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray recallZ-1064-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 17, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
FDA root cause category: Device Design
What the company is doing
Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.
Recall details
- Recall number
- Z-1064-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 17, 2022
- Posted by the FDA
- Feb 6, 2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 20 cases (120 units)
- Product code
- OGS
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Product description
UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
Code information (models, lots, serial numbers)
Item Number: DYNJ52230, Case UDI/GTIN: 40889942252269, Unit UDI/GTIN: 10889942252268, Lot Number: 22IBJ862
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ52230Medline Industries, Inc. · Nerve block tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 91386).
- Z-1060-2023 · Open, ClassifiedANCILLARY PACK-LF. Sterile Procedural Tray.
- Z-1061-2023 · Open, ClassifiedTRACH PACK. Sterile Procedural Tray.
- Z-1062-2023 · Open, ClassifiedLOCAL PACK. Sterile Procedural Tray.
- Z-1063-2023 · Open, ClassifiedSterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC
- Z-1065-2023 · Open, ClassifiedFEMORAL ARTERY PACK-LF. Sterile Procedural Tray
- Z-1066-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLANT PACK-LF; e. PORT PACEMAKER INSERTI…
- Z-1067-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALV…
- Z-1068-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV FISTULA PACK e. AV SHUNT PACK-LF f. RR-V…
- Z-1069-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECT…
- Z-1070-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL
- Z-1071-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
- Z-1072-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM …
- Z-1073-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
- Z-1074-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GENERAL LAPAROSCOPY PROCEDURE f. L…
- Z-1075-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
- Z-1076-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO
- Z-1077-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. P…
- Z-1078-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f.…
- Z-1079-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECO…
- Z-1080-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
- Z-1081-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
- Z-1082-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: IM NAIL
- Z-1083-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
- Z-1085-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: LS MS PACK
- Z-1086-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
- Z-1088-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-L…
- Z-1089-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN …
- Z-1090-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY
- Z-1091-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBO…
- Z-1092-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e. MAJOR ORTHO CDS-LF f. C-SECTION CDS g. C-SECTION…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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