Medline Industries, Inc.
Outpatient Port Access Dressing Chng KIT
24manufacturers in China registered for this device type
54,362catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (11), Anhui (6), Zhejiang (4). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Donghai Xingchen NON-Woven Products Co., Ltd. | North Donghai Development Zone, Lianyungang | Jiangsu | Contract manufacturer | 7 |
| Fengyang Jiehong Nonwoven Product Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 7 |
| 3A Medical Products Co., Ltd. | Liu An | Anhui | Contract manufacturer | 6 |
| Cobes Industries (Jinzhai) Co., Ltd. | Luan | Anhui | Contract manufacturer | 6 |
| Lianyungang Aiyeh Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 6 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Showing 12 of 24. All 24 manufacturers in China registered for General Surgery Tray
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | LRO |
| Device type | General Surgery Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| 510(k) | K213481 |
| Record published | 2024-09-08 |
| Record revised | 2025-04-14 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case of 2, case of 3, case of 4, case of 6, case of 5, case of 10 |
| Distribution end date | 2026-02-26 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYKM2740 | In distribution | |
| DYNJ59396C | In distribution | |
| EDUC05012 | In distribution | |
| DYNJ903428C | In distribution | |
| DYNJRA1278 | In distribution | |
| DYNJ87482 | In distribution | |
| DYNDC1162C | In distribution | |
| DYNJ30994B | In distribution | |
| DYNJ56900A | In distribution | |
| DYNJ39805 | In distribution | |
| DYNJ59622 | In distribution | |
| DYNJ48859 | In distribution | |
| DYNJ42935D | In distribution | |
| P6220 | In distribution | |
| DYNJ49439A | In distribution | |
| DYNJ49305A | In distribution | |
| DYNJ04594C | In distribution | |
| DYNJ37426B | In distribution | |
| DYNJ42426F | In distribution | |
| DYNJ88480 | In distribution | |
| DYKM2157C | In distribution | |
| DYNJ902778B | In distribution | |
| DYNJ46549B | In distribution | |
| CDS982384D | In distribution | |
| DYNJ53057A | In distribution | |
| DYKE1474A | In distribution | |
| DYNJ50395A | In distribution | |
| DYNJ52539B | In distribution | |
| SAMPC0334 | In distribution | |
| DYNJ33589G | In distribution | |
| DYNJ42031A | In distribution | |
| DYNJ903724D | In distribution | |
| DYNJ39511C | In distribution | |
| DYNJ48726 | In distribution | |
| DYNJ0708208I | In distribution | |
| DYNJ906269C | In distribution | |
| DYNJ61309C | In distribution | |
| DYNDA3162A | In distribution | |
| DYSAMP150118 | In distribution | |
| DYNDA2440 | In distribution | |
| DYNJ905315B | In distribution | |
| DYNJ61146G | In distribution | |
| DYNJ0161257G | In distribution | |
| DYNJ65584 | In distribution | |
| DYNJ0977553G | In distribution | |
| DYNJ64668 | In distribution | |
| TEST-SQ-04 | In distribution | |
| DYNJ58047A | In distribution | |
| CDS983305J | In distribution | |
| DYNJ0194974X | In distribution | |
| DYNJ902408A | In distribution | |
| DYNJ0925775Y | In distribution | |
| DYNJ35303C | In distribution | |
| DYNJ63699 | In distribution | |
| DYNJ85487A | In distribution | |
| DYNJ28990K | In distribution | |
| DYNJ0837617G | In distribution | |
| DYNJ58617B | In distribution | |
| DYNJ41213D | In distribution | |
| DYNJ54941A | In distribution | |
| DYNJ56890 | In distribution | |
| DYNJ36617G | In distribution | |
| 50KITNOLIDO | In distribution | |
| DYNJ57719A | In distribution | |
| DYNJ53429F | In distribution | |
| DYNJ39710A | In distribution | |
| DYNJ904903B | In distribution | |
| DYNJ908189 | In distribution | |
| DYNJ80189 | In distribution | |
| DYNJ64636A | In distribution | |
| ACC010445B | In distribution | |
| DYNDH1935 | In distribution | |
| DYNJ04589C | In distribution | |
| P482986 | In distribution | |
| DYNJ35406I | In distribution | |
| DYNJ62178 | In distribution | |
| DYNJ24347C | In distribution | |
| DYNJ53434F | In distribution | |
| DYNJRA1209 | In distribution | |
| DYNJ54116 | In distribution | |
| DYNJ49832A | In distribution | |
| DYKM1220B | In distribution | |
| CDS982989J | In distribution | |
| CDS980605N | In distribution | |
| DYNDA2251 | In distribution | |
| DYNJ0490280S | In distribution | |
| DYNJ57247C | In distribution | |
| DYNJT5370 | In distribution | |
| DYNJ54711D | In distribution | |
| DYNJ68068 | In distribution | |
| DYNJ905388A | In distribution | |
| DYNJ48752C | In distribution | |
| DYNJ0244777M | In distribution | |
| DYNJ65324A | In distribution | |
| DYNJ58912G | In distribution | |
| DYNJ68430A | In distribution | |
| DYNJ86041 | In distribution | |
| DYNJ35105J | In distribution | |
| DYNJ15670I | In distribution | |
| DYNJ88736 | In distribution | |
| DYNJ0190768O | In distribution | |
| DYNJ45029B | In distribution | |
| DYNJ54145C | In distribution | |
| DYNJ88111 | In distribution | |
| DYNJ0795930G | In distribution | |
| DYNJ56402 | In distribution | |
| DYNJ901571I | In distribution | |
| DYNJ44410D | In distribution | |
| ACC010401 | In distribution | |
| DYKS1246 | In distribution | |
| DYNJ17320B | In distribution | |
| DYNJ906781B | In distribution | |
| DYNJ83776 | In distribution | |
| DYNJ49804B | In distribution | |
| DYNJ63156 | In distribution | |
| DYNJ59138B | In distribution | |
| CDS984239O | In distribution | |
| DYNJ60781C | In distribution | |
| DYNJ53713C | In distribution | |
| DYNJ64119D | In distribution | |
| DYNJ0415909O | In distribution | |
| DYNJ84109D | In distribution | |
| DYNJ81289B | In distribution | |
| DYNJ04552M | In distribution | |
| DYNJ56041A | In distribution | |
| DYNJ47065A | In distribution | |
| DYNJHTSS09 | In distribution | |
| DYNJ53031 | In distribution | |
| DYNDA2338 | In distribution | |
| DYNJ58767 | In distribution | |
| DYNJ15992B | In distribution | |
| DYNJ48160D | In distribution | |
| DYNJ36488C | In distribution | |
| DYNJ33299B | In distribution | |
| DYNDS1060 | In distribution | |
| DYND71020 | In distribution | |
| DYNJ902844B | In distribution | |
| DYNJ52085O | In distribution | |
| DYNJ81070A | In distribution | |
| DYNJ82293B | In distribution | |
| DYNJ86157A | In distribution | |
| DYNJ40582B | In distribution | |
| DYNJ21831O | In distribution | |
| DYNJ56867 | In distribution | |
| PHS656461I | In distribution | |
| PHS816399002A | In distribution | |
| DYNJ20026L | In distribution | |
| CDS984538D | In distribution | |
| DYNJ902581 | In distribution | |
| DYNJ44622J | In distribution | |
| DYNJ52405K | In distribution | |
| DYNJ84021A | In distribution | |
| DYNJ910370A | In distribution | |
| CDS982482L | In distribution | |
| DYNJ36133C | In distribution | |
| DYNJ51712 | In distribution | |
| DYNJ35457B | In distribution | |
| DYNJ36194A | In distribution | |
| DYNJ04547P | In distribution | |
| DYNJ57535 | In distribution | |
| DYNJ59067 | In distribution | |
| DYKE1529C | In distribution | |
| PACH1104 | In distribution | |
| DYKS1170 | In distribution | |
| DYNJ0461620G | In distribution | |
| DYSAMP150122 | In distribution | |
| EDUC05047 | In distribution | |
| CVI4705A | In distribution | |
| PHS391536G | In distribution | |
| DYNJ81393B | In distribution | |
| DYNJ50184 | In distribution | |
| DYNJ0652788B | In distribution | |
| DYNJ38521A | In distribution | |
| DYNJ42702C | In distribution | |
| DYNJ36731C | In distribution | |
| CDS982022N | In distribution | |
| DYNDH1223 | In distribution | |
| DYNJ37304F | In distribution | |
| DYNJ44401F | In distribution | |
| DYNJ0608901C | In distribution | |
| PS002155019 | In distribution | |
| DYNJZ44653 | In distribution | |
| DYKM1342 | In distribution | |
| DYKC1181A | In distribution | |
| DYNJ0375869J | In distribution | |
| DYNJRA0235D | In distribution | |
| DYNJ903319J | In distribution | |
| DYNJ58517B | In distribution | |
| DYNJ86349A | In distribution | |
| DYNJ901498C | In distribution | |
| DYNJ60826 | In distribution | |
| DYNJ44534C | In distribution | |
| DYNDC3495 | In distribution | |
| DYNJ25797D | In distribution | |
| DYNJ32478C | In distribution | |
| DYNJ04589B | In distribution | |
| DYNJCD0080 | In distribution | |
| DYNJ57820F | In distribution | |
| DYNJ83992B | In distribution | |
| DYNJ86916A | In distribution | |
| DYNJ43212I | In distribution | |
| M101357 | In distribution | |
| PHS100072A | In distribution | |
| CDS984085I | In distribution | |
| CDS983982F | In distribution | |
| DYNJ53337F | In distribution | |
| DYNJ54364D | In distribution | |
| DYNJ68205 | In distribution | |
| DYNJ907846 | In distribution | |
| DYNJ80041 | In distribution | |
| DYNJ81292 | In distribution | |
| DYNJ909132B | In distribution | |
| DYNJ59302K | In distribution | |
| DYNJ9134088J | In distribution | |
| DYNJ904203A | In distribution | |
| PHS397101008C | In distribution | |
| DYNJ901166C | In distribution | |
| DYKE1763 | In distribution | |
| DYNJ65252A | In distribution | |
| DYNJ61043A | In distribution | |
| DYNDA2389A | In distribution | |
| DYNJ52424C | In distribution | |
| DYNJ0773979I | In distribution | |
| DYNJ04366N | In distribution | |
| DYNJ0258473U | In distribution | |
| DYNJ87456A | In distribution | |
| DYNJ60833C | In distribution | |
| DYNJ31727D | In distribution | |
| DYKC1286A | In distribution | |
| DYNJHTSS04A | In distribution | |
| DYNJ52391A | In distribution | |
| DYNJ904323 | In distribution | |
| DYNJ63746A | In distribution | |
| DYNJ50958I | In distribution | |
| DYNJ0368605I | In distribution | |
| DYNJ901813B | In distribution | |
| DYNJ60787 | In distribution | |
| DYNJ901437O | In distribution | |
| DYNJ51388C | In distribution | |
| DYNJ69907B | In distribution | |
| DYNJ59676 | In distribution | |
| DYNJ9426229Q | In distribution | |
| DYKC1378A | In distribution | |
| EDUC1041 | In distribution | |
| DYKM2703 | In distribution | |
| DYKS1108A | In distribution | |
| DYNJ81958B | In distribution | |
| DYNJ33623A | In distribution | |
| DYNJ31136A | In distribution | |
| DYNJ39429J | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 67,931 |
| Avid TruCustom | Avid Medical, Inc. | 13,498 |
| Halyard | Avid Medical, Inc. | 12,802 |
| ACS | American Contract Systems, Inc. | 10,337 |
| SurgiTrack | Owens & Minor Distribution, Inc. | 5,575 |
| Aligned Medical Solutions | Aligned Medical Solutions | 3,490 |
| SurgiTrackSM | Owens & Minor Distribution, Inc. | 3,364 |
| DeRoyal | Deroyal Industries, Inc. | 2,770 |
| Medline | Medline Industries, Inc. | 1,960 |
| Henry Schein | Henry Schein, Inc. | 729 |
| Stradis | Stradis Healthcare | 685 |
| Centurion | Centurion Medical Products Corporation | 672 |
Showing 12 of 113. All products under General Surgery Tray
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213481 | 2022-05-24 |
| K212258 | 2021-12-03 |
| K970286 | 1997-03-10 |
| K962826 | 1996-09-16 |
| K930700 | 1993-07-09 |
Recalls Naming This Product
142 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-08-11 | Not classified | Nonconforming Material/Component | The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products | 10407 kits |
| Medline Industries, LP – Northfield | 510(k) number | 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. | 60 |
| Medline Industries, LP – Northfield | 510(k) number | 2026-07-23 | Not classified | 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 cannu | 135 units |
| Medline Industries, LP – Northfield | 510(k) number | 2026-07-20 | Class II | 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 lea | 222,653 total |
| Medline Industries, LP – Northfield | 510(k) number | 2026-07-10 | Class II | Process change control | Kits contain a potentially contaminated component which were recalled by the manufacturer | 663 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-07-08 | Class II | 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. | 246 kits |
| Medline Industries, LP – Northfield | 510(k) number | 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 | 434,595 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-06-11 | Class II | Process change control | Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species. | 398 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-06-10 | Class II | 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 f | 163 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-06-08 | Class I | 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. | 52 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-06-08 | Class II | Nonconforming Material/Component | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhi | 980 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-06-05 | Class I | 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 Medic | 60 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-05-28 | Class II | 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 d | 9,272 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-05-28 | Class II | 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 d | 9,272 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-05-28 | Class II | 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 i | 396 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-05-21 | Class II | 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 in | 48075 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-05-06 | Class I | Nonconforming Material/Component | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA i | 503 units |
| Medline Industries, LP – Northfield | 510(k) number | 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 | 123030 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 | 510(k) number | 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 | 510(k) number | 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 | 510(k) number | 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 | 510(k) number | 2026-04-10 | Class I | 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 complai | 30120 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-03-24 | Class I | Under Investigation by firm | Medline has identified the presence of particulate within the fluid path of the Manifolds. | 21119 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. | 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. | 538201 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 | 510(k) number | 2026-03-16 | Class II | Under Investigation by firm | On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile. | 640 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-03-16 | Class II | 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 the | 40845 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. | 1752096 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. | 79843 units |
| 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 | 510(k) number | 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 | 510(k) number | 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. | 38014 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-18 | Class II | Under Investigation by firm | There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility. | 420 units |
| Medline Industries, LP – Northfield | 510(k) number | 2026-02-16 | Class II | 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 fragmen | 14,379 kits total |
Showing 40 of 142.
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.