510(k) · Cleared
Recalled · Class I · 2026Medline General Surgery Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · LRO General Surgery Tray
Cleared on May 24, 2022 after a 207-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has a Class I recall. It has been recalled 47 times, including 11 Class I recalls.
- Decided
- May 24, 2022
- Review
- 207 days
- Class
- Class II
- Product code
- LRO
- Recalls
- 47 (11 Class I)
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LRO device
- #1 K212258 Medline Cardiovascular Procedure Kitscore 2.5 · 1 generation · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2026 | Class II | Z-3229-2026 | Under Investigation by firm | 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 injury/abrasion and infection. |
| Aug 10, 2026 | Class II | Z-3267-2026 | Nonconforming Material/Component | 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 intervention, such as neurovascular adverse… |
| Jul 31, 2026 | Class II | Z-3209-2026 | Under Investigation by firm | 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 if product is used. |
| Jul 23, 2026 | Class II | Z-3137-2026 | Packaging process control | 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 not identified prior to use and the… |
| Jul 20, 2026 | Class II | Z-3070-2026 | Nonconforming Material/Component | 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 potentially contaminated applicator may… |
| Jul 10, 2026 | Class II | Z-3024-2026 | Process change control | Kits contain a potentially contaminated component which were recalled by the manufacturer |
| Jul 8, 2026 | Class II | Z-2995-2026 | Nonconforming Material/Component | 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 the neurosponges. |
| Jun 12, 2026 | Class II | Z-3054-2026 | Nonconforming Material/Component | 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 seal area. If the sterile barrier is… |
| Jun 10, 2026 | Class II | Z-2736-2026 | Under Investigation by firm | 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 insignificant extension of surgery to… |
| Jun 8, 2026 | Class I | Z-2764-2026 | Nonconforming Material/Component | 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 ineffectiveness. |
| Jun 5, 2026 | Class I | Z-2748-2026 | Under Investigation by firm | 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 notified by their supplier, Spectra… |
| Jun 5, 2026 | Class I | Z-2747-2026 | Under Investigation by firm | 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 notified by their supplier, Spectra… |
| Jun 5, 2026 | Class I | Z-2749-2026 | Under Investigation by firm | 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 notified by their supplier, Spectra… |
| May 28, 2026 | Class II | Z-2611-2026 | Process change control | 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 has led to instances of leakage, lumen… |
| May 28, 2026 | Class II | Z-2697-2026 | Under Investigation by firm | 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 temperature probe-size 9 due to an error in… |
| May 21, 2026 | Class II | Z-2541-2026 | Nonconforming Material/Component | 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 identified during a recent FDA manufacturing… |
| May 4, 2026 | Class II | Z-2497-2026 | Nonconforming Material/Component | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached… |
| Apr 27, 2026 | Class II | Z-2440-2026 | Process control | 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 | Process control | 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 | Process control | 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 | Component design/selection | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy… |
| Mar 16, 2026 | Class II | Z-1824-2026 | Under Investigation by firm | 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 | Under Investigation by firm | 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 Prep Pads to be non-sterile following… |
| Feb 27, 2026 | Class II | Z-2590-2026 | No Marketing Application | 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 | Component change control | Unapproved design changes to the products outside of the 510(k) clearance. |
| Feb 16, 2026 | Class II | Z-1710-2026 | Under Investigation by firm | 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 consequences associated with detachment of… |
| Jan 8, 2026 | Class II | Z-1466-2026 | Process control | 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 path identified by the inability of… |
| Jan 7, 2026 | Class II | Z-2101-2026 | Process control | 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… |
| Dec 24, 2025 | Class II | Z-1330-2026 | Packaging change control | 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 applicators. |
| Oct 10, 2025 | Class I | Z-0448-2026 | Nonconforming Material/Component | 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 inhaled anesthetic agents, which may… |
| Sep 10, 2025 | Class II | Z-0137-2026 | Process control | 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 | Process control | Convenience kits labeled as sterile have not gone through the sterilization process. |
| Jul 8, 2025 | Class II | Z-2452-2025 | Unknown/Undetermined by firm | 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 from the bladder at the welded… |
| Apr 22, 2025 | Class I | Z-1810-2025 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Process change control | 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 | Packaging process control | Potential breach in pouch packaging which could lead to loss of sterility. |
| Jan 9, 2025 | Class II | Z-1183-2025 | Under Investigation by firm | 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 to be replaced. |
| Dec 31, 2024 | Class I | Z-0991-2025 | Process design | 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 | Process change control | 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 | Nonconforming Material/Component | 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 | Under Investigation by firm | 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 testing requirements of EN 14683. |
| Aug 28, 2024 | Class II | Z-0119-2025 | Under Investigation by firm | 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 incorrectly labeled as model 30000. |
| Apr 8, 2024 | Class II | Z-2775-2024 | Under Investigation by firm | 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 patient health. |
| Apr 8, 2024 | Class II | Z-2515-2024 | Under Investigation by firm | 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 patient health. |
| Apr 8, 2024 | Class II | Z-2767-2024 | Under Investigation by firm | 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 patient health. |
| Apr 8, 2024 | Class II | Z-2631-2024 | Nonconforming Material/Component | 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 patient health. |
The 5 latest of 47 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LRO devicesLRO General Surgery Tray: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · LRO
1in 2022
2007high 1 (2021) · low 0 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · LRO
Too few LRO 510(k)s in any year since 2007 to give a median.
Recalls per year · LRO
14in 2025
2007high 192 (2022) · low 0 (2008)2026
Class I (93 since 2007) Class II/III not classified
Adverse event reports per year · LRO
5,488in 2025
2007high 5,488 (2025) · low 5 (2009)2025
MAUDE reports naming product code LRO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 8 |
| 2008 | 0 | — | 0 | 8 |
| 2009 | 0 | — | 2 | 5 |
| 2010 | 0 | — | 1 | 23 |
| 2011 | 0 | — | 11 | 17 |
| 2012 | 0 | — | 4 | 64 |
| 2013 | 0 | — | 11 (11) | 25 |
| 2014 | 0 | — | 59 (58) | 59 |
| 2015 | 0 | — | 5 | 628 |
| 2016 | 0 | — | 4 | 805 |
| 2017 | 0 | — | 29 | 523 |
| 2018 | 0 | — | 31 | 384 |
| 2019 | 0 | — | 4 | 406 |
| 2020 | 0 | — | 3 | 767 |
| 2021 | 1 | — | 3 | 920 |
| 2022 | 1 | — | 192 | 1,134 |
| 2023 | 0 | — | 18 (2) | 1,913 |
| 2024 | 0 | — | 60 (1) | 3,031 |
| 2025 | 0 | — | 14 (5) | 5,488 |
| 2026 | 0 | — | 75 (16) | — |
What is it indicated for?
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K213481 · printed Nov 3, 2026
Cite this page
510(k) Report. “K213481: Medline General Surgery Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K213481
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026