Medline Industries, Inc.
Specials IR Minor Procedure PK
4manufacturers in China registered for this device type
23,145catalogue numbers in this listing
Who Else Makes It
Concentrated in Anhui (2), Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Anhui Medical Sterilizing Co., Ltd. | Hefei | Anhui | Contract manufacturer | 8 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | FDE |
| Device type | Laparoscopy Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Premarket notification | Exempt |
| Record published | 2019-01-27 |
| Record revised | 2024-01-31 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 2, case of 3, case of 4, case of 6, case of 5, case of 8 |
| Distribution end date | 2022-03-22 |
| UDI direct marking | Exempt |
Catalogue Numbers
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| DYNJ59313A | In distribution | |
| DYNJVA900006B | In distribution | |
| CDS983124C | In distribution | |
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 9,245 |
| ACS | American Contract Systems, Inc. | 988 |
| Aligned Medical Solutions | Aligned Medical Solutions | 156 |
| DeRoyal | Deroyal Industries, Inc. | 141 |
| Regard™ | ROi CPS LLC | 122 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 61 |
| Medline | Medline Industries, Inc. | 19 |
| Halyard | Avid Medical, Inc. | 13 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 9 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 7 |
| Henry Schein | Henry Schein, Inc. | 7 |
| Medical Action Industries | Medical Action Industries, Inc. | 5 |
Showing 12 of 17. All products under Laparoscopy Kit
Recalls Naming This Product
51 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-07-31 | Not classified | 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. | 459 |
| Medline Industries, LP – Northfield | UDI-DI | 2026-07-10 | Class II | Process change control | Kits contain a potentially contaminated component which were recalled by the manufacturer | 94 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-06-12 | Class II | 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 co | 176 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-05-04 | Class II | 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 pr | 10415 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-05-04 | Class II | 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 pr | 37324 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-04-27 | Class II | Process control | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | 49,654 kits total |
| Medline Industries, LP – Northfield | UDI-DI | 2026-03-19 | Class II | Under Investigation by firm | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | 486946 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-03-19 | Class II | Under Investigation by firm | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | 21288 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-03-19 | Class II | Under Investigation by firm | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | 263739 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-03-19 | Class II | Under Investigation by firm | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | 1552486 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-27 | Class I | Under Investigation by firm | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | 20 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-27 | Class II | Component change control | Unapproved design changes to the products outside of the 510(k) clearance. | 270,311 total |
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-27 | Class II | 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. | 113,843 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Under Investigation by firm | 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 have | 82597 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | 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 have | 114778 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-12-16 | Class II | Under Investigation by firm | Medline kits containing Stryker’s Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design chang | 41432 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-12-12 | Class II | Nonconforming Material/Component | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive. | 456 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-11-26 | Class II | Nonconforming Material/Component | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions. | 33 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-10-10 | Class I | 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 resu | 96,406 total units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-09-30 | Class II | Under Investigation by firm | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previousl | 28679 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2025-03-19 | Class II | Under Investigation by firm | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening. | 240 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-03-03 | Class II | Under Investigation by firm | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. | 4022 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-03-03 | Class II | Under Investigation by firm | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. | 14760 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-02-21 | Class I | Other | Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula. | 468 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-02-13 | Class II | Packaging process control | Potential breach in pouch packaging which could lead to loss of sterility. | 506 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-02-11 | Class II | 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. | 11,774 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-11-21 | Class II | 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. | 943 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-11-21 | Class II | 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. | 474300 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-11-06 | Class II | Nonconforming Material/Component | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have r | 318 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2024-10-25 | Class II | Labeling Change Control | Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which ut | 100 |
| Medline Industries, LP – Northfield | UDI-DI | 2024-10-09 | Class II | Under Investigation by firm | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. | 24754 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-10-09 | Class II | Under Investigation by firm | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. | 167074 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-10-09 | Class II | Under Investigation by firm | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. | 252162 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-09-04 | Class II | Under Investigation by firm | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. | 5972 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-09-04 | Class II | Under Investigation by firm | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. | 12,583 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-08-28 | Class II | Unknown/Undetermined by firm | CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the collection and extraction of tissues, organs, and calculi d | 72 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2024-06-27 | Class II | Process control | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suc | 358 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-03-22 | Class II | Under Investigation by firm | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. | 22891 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-03-14 | Class II | Process control | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. | 12,588 total sterile kits |
| Medline Industries, LP – Northfield | UDI-DI | 2024-03-14 | Class II | Process control | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. | 12,588 total sterile kits |
Showing 40 of 51.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.