Tray, Surgical
FDA product code LRP · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
22510(k) clearances
0PMA approvals
109recalls
Manufacturers
- Cush Medical Products 2
- APK Technology Co., Ltd. 2
- J.J. Skinner, Inc. 1
- Grand Medical Products 1
- Osteotech, Inc. 1
- Associated Medical 1
- Cushindu 1
- Savoy Medical Supply Co., Inc. 1
- Medical Device Inspection Co., Inc. 1
- Angiosystems, Inc. 1
- Landmark Plastics 1
- Mumtaz I. Malik 1
- Site Microsurgical Systems, Inc. 1
- East Texas Lighthouse For the Blind 1
- CooperVision, Inc. 1
- Precision Dynamics Corp. 1
- Todd Medical, Inc. 1
- Advantage Medical Systems, Inc. 1
- Ulti-Med Intl., Inc. 1
- Pro-Lab, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963723 | Laceration TrayLRP · Traditional | Grand Medical Products | 11/27/1996SE |
| K951811 | Osteotech Musculoskeletal Tissue Recovery PackLRP · Traditional | Osteotech, Inc. | 05/31/1995SE |
| K940239 | Eye TrayLRP · Traditional | Cush Medical Products | 06/28/1994SEKD |
| K935621 | Custom ENT PacksLRP · Traditional | Associated Medical | 03/30/1994SE |
| K940646 | Orthopedic Tray Product LineLRP · Traditional | Cushindu | 03/11/1994SEKD |
| K940444 | General Surgery TrayLRP · Traditional | Cush Medical Products | 03/07/1994SEKD |
| K922126 | Hospital Kit ENT 1125LRP · Traditional | Savoy Medical Supply Co., Inc. | 01/21/1993SE |
| K912105 | Eye TrayLRP · Traditional | Medical Device Inspection Co., Inc. | 08/29/1991SE |
| K903963 | Kits and Trays for One Time Use OnlyLRP · Traditional | Apk Technology | 07/29/1991SEKD |
| K903962 | Instruments for One Time Use/ DisposableLRP · Traditional | Apk Technology | 07/29/1991SEKD |
| K905462 | Procedure Tray/For Various Ophthalmic ProceduresLRP · Traditional | Angiosystems, Inc. | 02/06/1991SE |
| K903544 | Carekits(Tm) Incision/Drainage/Suture Removal KitsLRP · Traditional | J.J. Skinner, Inc. | 08/31/1990SESD |
| K890071 | Sterile Laceration TrayLRP · Traditional | Mumtaz I. Malik | 01/24/1989SE |
| K883098 | Site Sterilization Trays for Ophthalmic UseLRP · Traditional | Site Microsurgical Systems, Inc. | 08/18/1988SE |
| K882275 | Sterile Pack (Procedural Tray/Kits)LRP · Traditional | East Texas Lighthouse For the Blind | 07/18/1988SE |
| K881095 | Koi(Tm) Instrument TraysLRP · Traditional | CooperVision, Inc. | 04/06/1988SE |
| K874665 | Securline Fine Needle Aspiration Biopsy TrayLRP · Traditional | Precision Dynamics Corp. | 01/20/1988SESD |
| K873469 | Todd Medical/Skilled Care ProductsLRP · Traditional | Todd Medical, Inc. | 10/29/1987SE |
| K873290 | Laceration and Instrument TraysLRP · Traditional | Advantage Medical Systems, Inc. | 09/24/1987SE |
| K873439 | Laceration TrayLRP · Traditional | Ulti-Med Intl., Inc. | 09/11/1987SE |
| K861142 | Master Kit BLRP · Traditional | Pro-Lab, Inc. | 07/10/1986SESD |
| K760497 | Tray, ServiceLRP · Traditional | Landmark Plastics | 11/12/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3254-2026 | Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU…The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator.… | Cardinal Health 200, LLC | 08/10/2026Open, Classified |
| Z-3096-2026 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-3055-2026 Class II | Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295The 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-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… | Medline Industries, LP | 05/21/2026Open, Classified |
| Z-2414-2026 Class II | Medline EBSI Kit EBSI1534Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… | Medline Industries, LP | 04/27/2026Open, Classified |
| Z-2028-2026 Class II | Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows:…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | Medline Industries, LP | 03/19/2026Open, Classified |
| Z-2042-2026 Class II | Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | Medline Industries, LP | 03/16/2026Open, 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… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1400-2026 Class II | Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1710-2025 Class II | Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535It 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-1603-2025 Class II | Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model Number:…There 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-0992-2025 Class I | Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE…The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the… | MEDLINE INDUSTRIES, LP - Northfield | 12/31/2024Open, Classified |
| Z-1041-2025 Class II | Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number…Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT… | MEDLINE INDUSTRIES, LP - Northfield | 11/18/2024Open, Classified |
| Z-0760-2025 Class II | RUMMELL, Medline Item No. ST006STWeak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to… | MEDLINE INDUSTRIES, LP - Northfield | 11/12/2024Open, Classified |
| Z-1127-2025 Class II | Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14…Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Cardinal Health 200, LLC | 11/08/2024Open, Classified |
| Z-0167-2025 Class II | Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | MEDLINE INDUSTRIES, LP - Northfield | 09/04/2024Open, Classified |
| Z-0150-2025 Class II | Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | MEDLINE INDUSTRIES, LP - Northfield | 09/04/2024Open, Classified |
| Z-3020-2024 Class II | Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2776-2024 Class II | Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2768-2024 Class II | Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2752-2024 Class II | Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2632-2024 Class II | Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2516-2024 Class II | Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-1917-2024 Class II | Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience trayTrumpet Needle Guide ring can detach when excessive pressure is applied. | MEDLINE INDUSTRIES, LP - Northfield | 03/01/2024Open, Classified |
| Z-1443-2024 Class II | Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | MEDLINE INDUSTRIES, LP - Northfield | 02/23/2024Open, Classified |
| Z-1132-2024 Class I | Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | MEDLINE INDUSTRIES, LP - Northfield | 11/15/2023Open, Classified |
| Z-1112-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | MEDLINE INDUSTRIES, LP - Northfield | 11/15/2023Open, Classified |
| Z-2199-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | MEDLINE INDUSTRIES, LP - Northfield | 05/18/2023Open, Classified |
| Z-2182-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | MEDLINE INDUSTRIES, LP - Northfield | 05/18/2023Open, Classified |
| Z-2322-2023 Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.…Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. | MEDLINE INDUSTRIES, LP - Northfield | 05/15/2023Open, Classified |
| Z-1119-2023 Class II | Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | MEDLINE INDUSTRIES, LP - Northfield | 12/07/2022Open, Classified |
| Z-0167-2023 Class II | CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit…Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings… | MEDLINE INDUSTRIES, LP - Northfield | 09/30/2022Open, Classified |
| Z-1683-2022 Class II | Medline CHEST TUBE REORDER NO: DYNJ36762ADue to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit | Medline Industries Inc. | 07/21/2022Open, Classified |
| Z-3016-2020 Class II | KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S.…Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment. | Cardinal Health 200, LLC | 07/30/2020Terminated |
| Z-0865-2020 Class II | Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia…There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier. | Medline Industries Inc | 01/07/2020Terminated |
| Z-1094-2020 Class II | Centurion- UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL…Incomplete seals on the sterile package may compromise the sterility | Centurion Medical Products Corporation | 12/11/2019Terminated |
| Z-1088-2020 Class II | Centurion- OR2020 BASIN SETIncomplete seals on the sterile package may compromise the sterility | Centurion Medical Products Corporation | 12/11/2019Terminated |
| Z-1084-2020 Class II | Centurion IVS3505 ULTRASOUND GUIDED PIV KITIncomplete seals on the sterile package may compromise the sterility | Centurion Medical Products Corporation | 12/11/2019Terminated |
| Z-1083-2020 Class II | Centurion-Irrigation Kit IG25STSS IRRIGATION GUN &VALVE SET W/SPLASHSHIELD YIncomplete seals on the sterile package may compromise the sterility | Centurion Medical Products Corporation | 12/11/2019Terminated |
| Z-1081-2020 Class II | Centurion- I86625 DEBRIDEMENT TRAYIncomplete seals on the sterile package may compromise the sterility | Centurion Medical Products Corporation | 12/11/2019Terminated |
| Z-1076-2020 Class II | Centurion-Trays DYNTray, surgicalJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN…Incomplete seals on the sterile package may compromise the sterility | Centurion Medical Products Corporation | 12/11/2019Terminated |
| Z-1075-2020 Class II | Centurion-Suture Tray DYNDR1210A SUTURING TRAYIncomplete seals on the sterile package may compromise the sterility | Centurion Medical Products Corporation | 12/11/2019Terminated |
| Z-1073-2020 Class II | Centurion-Drive Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM 2-7…Incomplete seals on the sterile package may compromise the sterility | Centurion Medical Products Corporation | 12/11/2019Terminated |
| Z-1070-2020 Class II | Centurion- Biopsy Tray TRIBT170 BIOPSY TRAYIncomplete seals on the sterile package may compromise the sterility | Centurion Medical Products Corporation | 12/11/2019Terminated |
| Z-1065-2020 Class II | Centurion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525…Incomplete seals on the sterile package may compromise the sterility | Centurion Medical Products Corporation | 12/11/2019Terminated |
| Z-1062-2020 Class II | Centurion-BIOPSY TRAY BT205A MINOR SET UP BIOPSY TRAY BT345A HH PACK BIOPSYIncomplete seals on the sterile package may compromise the sterility | Centurion Medical Products Corporation | 12/11/2019Terminated |
| Z-1059-2020 Class II | Centurion- Umbilical Vessel UPC175 UMBILICAL VESSEL CATH. INSERTION UPC175 UMBILICAL…Incomplete seals on the sterile package may compromise the sterility | Centurion Medical Products Corporation | 12/11/2019Terminated |
| Z-1058-2020 Class II | Centurion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065…Incomplete seals on the sterile package may compromise the sterility | Centurion Medical Products Corporation | 12/11/2019Terminated |
| Z-1057-2020 Class II | Centurion-Suture Trays SUT10140 SUTURE TRAY SUT10290 LACERATION TRAY SUT10705 SUTURING…Incomplete seals on the sterile package may compromise the sterility | Centurion Medical Products Corporation | 12/11/2019Terminated |
| Z-1054-2020 Class II | Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY…Incomplete seals on the sterile package may compromise the sterility | Centurion Medical Products Corporation | 12/11/2019Terminated |