# K213481: Medline General Surgery Tray

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: May 24, 2022 after 207 days
- Product code: LRO (General Surgery Tray)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 47 (11 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Aug 10, 2026 · Class II · Z-3229-2026: Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut
- Aug 10, 2026 · Class II · Z-3267-2026: The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical inter
- Jul 31, 2026 · Class II · Z-3209-2026: Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection 
- Jul 23, 2026 · Class II · Z-3137-2026: The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is n
- Jul 20, 2026 · Class II · Z-3070-2026: Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of pot
- Jul 10, 2026 · Class II · Z-3024-2026: Kits contain a potentially contaminated component which were recalled by the manufacturer
- Jul 8, 2026 · Class II · Z-2995-2026: Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of 
- Jun 12, 2026 · Class II · Z-3054-2026: The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the
- Jun 10, 2026 · Class II · Z-2736-2026: Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically
- Jun 8, 2026 · Class I · Z-2764-2026: The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug i
- Jun 5, 2026 · Class I · Z-2748-2026: Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was n
- Jun 5, 2026 · Class I · Z-2747-2026: Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was n
- Jun 5, 2026 · Class I · Z-2749-2026: Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was n
- May 28, 2026 · Class II · Z-2611-2026: Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This 
- May 28, 2026 · Class II · Z-2697-2026: Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temper
- May 21, 2026 · Class II · Z-2541-2026: 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 identif
- May 4, 2026 · Class II · Z-2497-2026: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances 
- Apr 27, 2026 · Class II · Z-2440-2026: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Apr 27, 2026 · Class II · Z-2441-2026: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Apr 27, 2026 · Class II · Z-2439-2026: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Apr 10, 2026 · Class I · Z-2236-2026: Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrit
- Mar 16, 2026 · Class II · Z-1824-2026: On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.
- Mar 16, 2026 · Class II · Z-2041-2026: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Pr
- Feb 27, 2026 · Class II · Z-2590-2026: Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
- Feb 27, 2026 · Class II · Z-1890-2026: Unapproved design changes to the products outside of the 510(k) clearance.
- Feb 16, 2026 · Class II · Z-1710-2026: Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequenc
- Jan 8, 2026 · Class II · Z-1466-2026: Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid
- Jan 7, 2026 · Class II · Z-2101-2026: 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,
- Dec 24, 2025 · Class II · Z-1330-2026: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the a
- Oct 10, 2025 · Class I · Z-0448-2026: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of i
- Sep 10, 2025 · Class II · Z-0137-2026: Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.
- Aug 8, 2025 · Class I · Z-2592-2025: Convenience kits labeled as sterile have not gone through the sterilization process.
- Jul 8, 2025 · Class II · Z-2452-2025: Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach 
- Apr 22, 2025 · Class I · Z-1810-2025: Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
- Apr 22, 2025 · Class I · Z-1809-2025: Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
- Feb 24, 2025 · Class I · Z-1505-2025: Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.
- Feb 13, 2025 · Class II · Z-1368-2025: Potential breach in pouch packaging which could lead to loss of sterility.
- Jan 9, 2025 · Class II · Z-1183-2025: Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs 
- Dec 31, 2024 · Class I · Z-0991-2025: The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
- Dec 23, 2024 · Class II · Z-1049-2025: Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
- Nov 21, 2024 · Class II · Z-0788-2025: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
- Nov 18, 2024 · Class II · Z-1040-2025: Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testi
- Aug 28, 2024 · Class II · Z-0119-2025: Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was
- Apr 8, 2024 · Class II · Z-2775-2024: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to pat
- Apr 8, 2024 · Class II · Z-2515-2024: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to pat
- Apr 8, 2024 · Class II · Z-2767-2024: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to pat
- Apr 8, 2024 · Class II · Z-2631-2024: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to pat

## Indications for use
The Medline General Surgery Tray contains a single-use sterile surgical drape intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The drape is packaged and sterilized with disposable devices intended for professional use/used by licensed physicians in preparing the operating environment for, and performing procedures and surgeries. The intended use of the medical products assembled in these kits will not be changed from the manufacturer's original intended use.

Source page: https://510kreport.com/device/K213481
Methodology: https://510kreport.com/methodology