Orthopedic Tray
FDA product code OJH · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
0510(k) clearances
0PMA approvals
237recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3105-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | Cardinal Health 200, LLC | 07/29/2026Open, Classified |
| Z-3079-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-2948-2026 Class II | Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2)…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | Cardinal Health 200, LLC | 07/14/2026Open, Classified |
| Z-3029-2026 Class II | Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON…Kits contain a potentially contaminated component which were recalled by the manufacturer | Medline Industries, LP | 07/10/2026Open, Classified |
| Z-2997-2026 Class II | Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU…Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and… | Medline Industries, LP | 07/08/2026Open, Classified |
| Z-3062-2026 Class II | Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; 2) SHOULD…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-2791-2026 Class II | Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU…Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL… | Medline Industries, LP | 06/11/2026Open, Classified |
| Z-2737-2026 Class II | Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF…Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which… | Medline Industries, LP | 06/10/2026Open, Classified |
| Z-2802-2026 Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack…The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific… | Windstone Medical Packaging, Inc. | 06/08/2026Open, Classified |
| Z-2765-2026 Class I | MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU…The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2749-2026 Class I | MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2)…Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits… | Medline Industries, LP | 06/05/2026Open, Classified |
| Z-3046-2026 Class II | Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number…The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific… | AVID Medical, Inc. | 05/19/2026Open, Classified |
| Z-2990-2026 Class II | American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR…The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific… | American Contract Systems Inc | 05/19/2026Open, Classified |
| Z-2508-2026 Class II | MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097…During an internal review, Medline identified representative samples did not meet applicable performance… | Medline Industries, LP | 05/04/2026Open, Classified |
| Z-2410-2026 Class II | Halyard, Eye Bag Pack. Kit Code: UIEB48-01.Inadvertent distribution of sealed pouches that had not undergone validated sterilization. | AVID Medical, Inc. | 04/30/2026Open, Classified |
| Z-2409-2026 Class II | Halyard, Drape Pack. Kit Code: LMDP36-01.Inadvertent distribution of sealed pouches that had not undergone validated sterilization. | AVID Medical, Inc. | 04/30/2026Open, Classified |
| Z-2407-2026 Class II | Halyard, Pain Pack. Kit Code: AMPK48-01.Inadvertent distribution of sealed pouches that had not undergone validated sterilization. | AVID Medical, Inc. | 04/30/2026Open, Classified |
| Z-2436-2026 Class II | Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ910821A ACDF PACK…Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… | Medline Industries, LP | 04/27/2026Open, 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… | Medline Industries, LP | 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… | Medline Industries, LP | 04/10/2026Open, Classified |
| Z-2038-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total)…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | Medline Industries, LP | 03/19/2026Open, Classified |
| Z-1974-2026 Class I | Halyard CATH LAB kit. Model Number: SACL75-01.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose… | AVID Medical, Inc. | 03/13/2026Open, Classified |
| Z-2587-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1887-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1730-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1849-2026 Class II | Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | Medline Industries, LP | 02/25/2026Open, Classified |
| Z-1711-2026 Class II | MEDLINE ANTERIOR HIP PACK DYNJ64672BKits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated… | Medline Industries, LP | 02/16/2026Open, 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… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1421-2026 Class II | Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1200-2026 Class II | Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… | Medline Industries, LP | 12/12/2025Open, Classified |
| Z-1060-2026 Class II | Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets…Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to… | Medline Industries, LP | 11/26/2025Open, Classified |
| Z-0451-2026 Class I | Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR…Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | Medline Industries, LP | 10/10/2025Open, Classified |
| Z-0530-2026 Class II | MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2)…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | Medline Industries, LP | 09/30/2025Open, Classified |
| Z-0184-2026 Class II | Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | American Contract Systems Inc. | 09/04/2025Open, Classified |
| Z-2593-2025 Class I | Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701BConvenience kits labeled as sterile have not gone through the sterilization process. | Medline Industries, LP | 08/08/2025Open, Classified |
| Z-2472-2025 Class II | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP…During an internal investigation, ACS determined that the rationale for sterilization of certain components… | American Contract Systems Inc | 07/14/2025Open, Classified |
| Z-1811-2025 Class I | Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU…Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on… | MEDLINE INDUSTRIES, LP - Northfield | 04/22/2025Open, Classified |
| Z-1916-2025 Class II | LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK…Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene… | American Contract Systems, Inc. | 04/21/2025Open, Classified |
| Z-1714-2025 Class II | Medline procedure kits, labeled as: HAND, REF DYNJ902002JIt was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking… | MEDLINE INDUSTRIES, LP - Northfield | 03/19/2025Open, Classified |
| Z-1618-2025 Class II | Refer to RESThere is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | MEDLINE INDUSTRIES, LP - Northfield | 03/03/2025Open, Classified |
| Z-1370-2025 Class II | Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL…Potential breach in pouch packaging which could lead to loss of sterility. | MEDLINE INDUSTRIES, LP - Northfield | 02/13/2025Open, Classified |
| Z-1465-2025 Class II | Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 02/11/2025Open, Classified |
| Z-1347-2025 Class II | TOTAL HIP PACK , Model No SMTH06O SMTH06PACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | American Contract Systems Inc | 02/06/2025Open, Classified |
| Z-1333-2025 Class II | HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | American Contract Systems Inc | 02/06/2025Open, Classified |
| Z-0794-2025 Class II | Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2)…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | MEDLINE INDUSTRIES, LP - Northfield | 11/21/2024Open, Classified |
| Z-1135-2025 Class II | Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2)…Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Cardinal Health 200, LLC | 11/08/2024Open, Classified |
| Z-0916-2025 Class II | Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number:…Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Cardinal Health 200, LLC | 11/08/2024Open, Classified |
| Z-0726-2025 Class II | Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF…Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | MEDLINE INDUSTRIES, LP - Northfield | 11/06/2024Open, Classified |
| Z-0534-2025 Class II | Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture… | MEDLINE INDUSTRIES, LP - Northfield | 10/15/2024Open, Classified |
| Z-0649-2025 Class II | MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | MEDLINE INDUSTRIES, LP - Northfield | 10/09/2024Open, Classified |