Medline Industries, Inc.
Breast Reconstructn CDS UCC-LF
2manufacturers in China registered for this device type
4,366catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | FTN |
| Device type | Plastic Surgery And Accessories Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3925 |
| Premarket notification | Exempt |
| Record published | 2021-09-01 |
| Record revised | 2025-01-22 (version 9) |
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 | 2021-07-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNJ63994A | In distribution | |
| DYNJ57642D | In distribution | |
| DYNJ50355C | In distribution | |
| CDS980457R | In distribution | |
| DYNJ906754 | In distribution | |
| DYNJ906376A | In distribution | |
| DYNJG001011 | In distribution | |
| DYNJ903464C | In distribution | |
| DYNJ57926J | In distribution | |
| DYNJ59679A | In distribution | |
| DYNJ50957D | In distribution | |
| DYNJ51081F | In distribution | |
| DYNJ56609B | In distribution | |
| DYNJ0578842M | In distribution | |
| DYNJ907410A | In distribution | |
| DYNJ904825D | In distribution | |
| DYNJ906707 | In distribution | |
| DYNJ85436A | In distribution | |
| DYNDA1567C | In distribution | |
| DYNJ63369D | In distribution | |
| DYNJ64712A | In distribution | |
| DYNDA2806 | In distribution | |
| DYNJ58264D | In distribution | |
| DYNJ0940778D | In distribution | |
| DYNJ0943563AA | In distribution | |
| CDS984362I | In distribution | |
| DYNJ910456A | In distribution | |
| DYNJ69484A | In distribution | |
| DYNJ55358D | In distribution | |
| DYNJ89537 | In distribution | |
| DYKMBNDL69A | In distribution | |
| DYNJ84523 | In distribution | |
| DYNJ900342D | In distribution | |
| DYNJ57222I | In distribution | |
| DYNJ910234 | In distribution | |
| DYNJ84827C | In distribution | |
| DYNJ65980D | In distribution | |
| DYNJ900610D | In distribution | |
| DYNJ68321 | In distribution | |
| DYNJT4423 | In distribution | |
| DYNJ40637F | In distribution | |
| DYNJ900117F | In distribution | |
| DYKMBNDL97A | In distribution | |
| DYNJ67803B | In distribution | |
| DYNJ69594A | In distribution | |
| DYNJ0943563AC | In distribution | |
| DYNJ910727A | In distribution | |
| DYNJ35665B | In distribution | |
| DYNJ82828 | In distribution | |
| DYNJ903851A | In distribution | |
| DYNJ89023 | In distribution | |
| DYNJCD0210A | In distribution | |
| DYNJT5196 | In distribution | |
| DYNJ84294 | In distribution | |
| DYNJ904762D | In distribution | |
| DYNJ60157A | In distribution | |
| DYNJ56528A | In distribution | |
| DYNJ47799D | In distribution | |
| DYNJ904158F | In distribution | |
| DYNJ25730L | In distribution | |
| DYNJ43942 | In distribution | |
| DYNJ905702C | In distribution | |
| DYNJ82393 | In distribution | |
| DYNJ83856A | In distribution | |
| DYNJ60080B | In distribution | |
| DYNJ908029 | In distribution | |
| DYNJ82456 | In distribution | |
| CDS984539O | In distribution | |
| DYNJT3283 | In distribution | |
| DYNJ57222G | In distribution | |
| DYNJ905435B | In distribution | |
| DYNJ906674A | In distribution | |
| DYNJ82716 | In distribution | |
| DYNJ63493A | In distribution | |
| DYNJ906471G | In distribution | |
| DYNJT4005 | In distribution | |
| DYNJ81709B | In distribution | |
| DYNJ41846C | In distribution | |
| DYNJ54331 | In distribution | |
| DYNJ86736A | In distribution | |
| DYNJ82736 | In distribution | |
| DYNJ900563G | In distribution | |
| DYNJ69222C | In distribution | |
| DYNJ905287A | In distribution | |
| DYNJ905036 | In distribution | |
| DYNJ46620I | In distribution | |
| DYNJ68288A | In distribution | |
| DYNJ55518 | In distribution | |
| DYNJ234423 | In distribution | |
| DYNJ56344B | In distribution | |
| DYNJ57134A | In distribution | |
| DYNJ69139 | In distribution | |
| DYNJ905351G | In distribution | |
| DYNJ69594C | In distribution | |
| DYNJ85077B | In distribution | |
| DYNJ55954D | In distribution | |
| DYNJ902779F | In distribution | |
| DYNJ64927F | In distribution | |
| DYNJ81708 | In distribution | |
| DYNDP1107 | In distribution | |
| DYNJ910234A | In distribution | |
| DYNJ57809 | In distribution | |
| DYNJ67498 | In distribution | |
| DYNJ0564783AC | In distribution | |
| DYNJ59712A | In distribution | |
| M101344A | In distribution | |
| DYNJ0559655T | In distribution | |
| DYNJ63647 | In distribution | |
| DYNJ69390A | In distribution | |
| DYNJ37892C | In distribution | |
| DYNJ900489G | In distribution | |
| DYNJ905351F | In distribution | |
| DYNJ900426G | In distribution | |
| DYNJ49962K | In distribution | |
| DYNJT3898 | In distribution | |
| DYNJ57143B | In distribution | |
| DYNJ37142B | In distribution | |
| CDS984692F | In distribution | |
| DYNJ81655A | In distribution | |
| DYNJ67655A | In distribution | |
| DYNJ54576 | In distribution | |
| DYNJ57719I | In distribution | |
| DYNJ904456B | In distribution | |
| DYNJ86435A | In distribution | |
| DYNJ62671 | In distribution | |
| DYNJ64089 | In distribution | |
| DYNJ52998 | In distribution | |
| DYNJ0429387J | In distribution | |
| DYNJVA900020C | In distribution | |
| DYNDH1296A | In distribution | |
| DYNJ47842C | In distribution | |
| DYNJ60139C | In distribution | |
| DYNJ901298C | In distribution | |
| DYNJ64914A | In distribution | |
| VAL033PPSCB | In distribution | |
| DYNJ904569C | In distribution | |
| DYNJ83452A | In distribution | |
| DYNJ81985 | In distribution | |
| DYNJ0429387I | In distribution | |
| DYNJ57983A | In distribution | |
| DYNJ909948C | In distribution | |
| DYNJ903330Q | In distribution | |
| DYNDH1071 | In distribution | |
| DYNJ54092B | In distribution | |
| DYNJ48675C | In distribution | |
| PHS41746B | In distribution | |
| DYNJ904979B | In distribution | |
| DYNJ85690 | In distribution | |
| DYNJ81653B | In distribution | |
| DYNJ85077A | In distribution | |
| DYNJ906471B | In distribution | |
| VAL050PLBOB | In distribution | |
| DYNJ905365B | In distribution | |
| DYNJ66593 | In distribution | |
| DYNJ47947B | In distribution | |
| CDS982038T | In distribution | |
| DYNJ907074C | In distribution | |
| DYNJ902510B | In distribution | |
| DYNJ904539F | In distribution | |
| DYNJ28206J | In distribution | |
| DYNJ52658B | In distribution | |
| DYNJ907791C | In distribution | |
| DYNJ39225J | In distribution | |
| DYNJ63793A | In distribution | |
| DYNJ54833A | In distribution | |
| DYNJ39225D | In distribution | |
| DYNJ902875J | In distribution | |
| DYNJ49962N | In distribution | |
| DYNJ87503 | In distribution | |
| DYNJ906471D | In distribution | |
| DYNJ40140F | In distribution | |
| DYNJ47010D | In distribution | |
| DYNJ42833A | In distribution | |
| DYNJ62153A | In distribution | |
| DYNJ63612C | In distribution | |
| DYNJ48191G | In distribution | |
| DYNJ902703K | In distribution | |
| DYNJ25730K | In distribution | |
| DYNJ0943542M | In distribution | |
| DYNJ69104 | In distribution | |
| DYNJ903602F | In distribution | |
| DYNJ50489J | In distribution | |
| DYNJ910727 | In distribution | |
| DYNJ16539O | In distribution | |
| DYNJ84582 | In distribution | |
| DYNJ908729A | In distribution | |
| DYNJ69839A | In distribution | |
| DYNJ60511 | In distribution | |
| DYNJ81967B | In distribution | |
| DYNJ80336C | In distribution | |
| DYNJ54833 | In distribution | |
| CDS983141F | In distribution | |
| DYNJ36469J | In distribution | |
| DYNDH1374A | In distribution | |
| DYNJ50489C | In distribution | |
| DYNJ59400C | In distribution | |
| DYNJ47043B | In distribution | |
| DYNDH1101A | In distribution | |
| DYNJ69502A | In distribution | |
| DYNJ82998A | In distribution | |
| DYNJ40731G | In distribution | |
| DYNJ0415270M | In distribution | |
| DYNJ909719 | In distribution | |
| DYNJ57719C | In distribution | |
| DYNJ34160D | In distribution | |
| DYNJ61993 | In distribution | |
| DYNDA2926 | In distribution | |
| DYNJ61233B | In distribution | |
| DYNJ63793D | In distribution | |
| DYNJ67266B | In distribution | |
| DYKMBNDL34A | In distribution | |
| DYNJ906747D | In distribution | |
| DYNJ909231B | In distribution | |
| DYNJ86794 | In distribution | |
| DYNJ35968J | In distribution | |
| DYNJ63725 | In distribution | |
| DYNJ41846D | In distribution | |
| DYNJ60133 | In distribution | |
| DYNJ901792G | In distribution | |
| DYNJ82352 | In distribution | |
| DYNJ50957G | In distribution | |
| DYNJ0943557Y | In distribution | |
| DYNJ34020D | In distribution | |
| DYNJ00264J | In distribution | |
| DYNJ57463C | In distribution | |
| DYNJ69886A | In distribution | |
| DYNJ83788A | In distribution | |
| DYNJ89528 | In distribution | |
| DYKM1572B | In distribution | |
| DYNJ63893 | In distribution | |
| DYNJ87292A | In distribution | |
| DYNJ84511A | In distribution | |
| DYNJ900545D | In distribution | |
| DYNJ905747 | In distribution | |
| DYNJ88270B | In distribution | |
| DYNJ41911B | In distribution | |
| DYNJ60770B | In distribution | |
| DYNJ30115I | In distribution | |
| DYNJ83620A | In distribution | |
| DYNJ0129395N | In distribution | |
| DYNJ63753 | In distribution | |
| CDS982856G | In distribution | |
| DYNJ903678A | In distribution | |
| DYNJ82808 | In distribution | |
| DYNJ51082A | In distribution | |
| DYNJ62266C | In distribution | |
| DYNJ81707A | In distribution | |
| DYNJ0940741B | In distribution | |
| DYNJ02615G | In distribution | |
| DYNJ0785890R | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ACS | American Contract Systems, Inc. | 109 |
| Stradis | Stradis Healthcare | 102 |
| Henry Schein | Henry Schein, Inc. | 93 |
| Stradis Healthcare | Stradis Healthcare | 81 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 20 |
| Regard™ | ROi CPS LLC | 13 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 12 |
| Medline | Medline Industries, Inc. | 5 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 5 |
| Stradis Medical, LLC. | Stradis Healthcare | 5 |
| Invenio | GRI-Alleset, Inc. | 3 |
| Bausch and Lomb | Medline Industries, Inc. | 3 |
Showing 12 of 19. All products under Plastic Surgery And Accessories Kit
Recalls Naming This Product
30 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 | 2026-06-12 | 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 | 300 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 | 91 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. | 22116 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. | 60 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 | 2026-02-25 | Class II | No Marketing Application | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. | 36 units |
| 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 | 4757 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 | 5497 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. | 66 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. | 16 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 | 4214 kits |
| 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. | 4094 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. | 16 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. | 2161 kits |
| 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. | 14589 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. | 3903 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 | 40 kits |
| 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. | 25877 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. | 1048 units |
| 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 | 350 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. | 3539 units |
| Medline Industries, LP – Northfield | UDI-DI | 2023-11-15 | Class I | Nonconforming Material/Component | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse As | 139 units |
| Medline Industries, LP – Northfield | UDI-DI | 2023-05-18 | Class II | Device Design | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 4398 units |
| Medline Industries, LP – Northfield | UDI-DI | 2022-11-17 | Class II | Device Design | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | 42,593 cases (117,470 units) |
| Medline Industries, LP – Northfield | UDI-DI | 2022-11-17 | Class II | Device Design | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | 6,420 cases (15,009 units) |
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.