Kit, Surgical Instrument, Disposable
FDA product code KDD · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
62510(k) clearances
0PMA approvals
251recalls
Manufacturers
- Ulti-Med Intl., Inc. 3
- American Medical Disposable, Inc. 3
- Pro-Pak 3
- Megadyne Medical Products, Inc. 2
- E.M. Adams 2
- American Hospital Supply Corp. 2
- Pollak (Intl.), Ltd. 2
- Megaplast, Inc. 2
- Oem Medical Div. 1
- Ormed Mfg., Inc. 1
- I M, Inc. 1
- Covidien LLC 1
- Int'L Corp. 1
- Ackrad Laboratories 1
- M-C Ind., Inc. 1
- Cunningham Woodland, Inc. 1
- Walpak Co. 1
- Johnson & Johnson Professionals, Inc. 1
- Premium Plastics, Inc. 1
- Pharmaseal Div., Baxter Healthcare Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072814 | Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…KDD · Traditional | Covidien | 04/16/2008SE |
| K011514 | Instruments for One Time Use - DisposableKDD · Traditional | Kencap , Ltd. | 08/13/2001SE |
| K971317 | National Medical Healthcare Custom Orthopedic Kits and TraysKDD · Traditional | National Healthcare Mfg. Corp. | 05/08/1997SE |
| K960456 | Denver Paracentesis NEEDLE(60-1200) Denver Paracentesis Needle with Drainage…KDD · Traditional | Denver Biomaterials, Inc. | 04/01/1996SE |
| K936255 | Custom CV PackKDD · Traditional | Associated Medical | 03/31/1994SN |
| K932219 | Suture Set or Laceration Trays (Packs)KDD · Traditional | Associated Medical Products Co. | 07/09/1993SESK |
| K923176 | Surgical Instrument Kit, DisposableKDD · Traditional | Ulti-Med Intl., Inc. | 06/17/1993SE |
| K925905 | Kit, Surgical Instrument, DisposableKDD · Traditional | Kay Medical Concepts | 06/16/1993SESK |
| K924958 | Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep TrayKDD · Traditional | Medical Insights, Inc. | 06/07/1993SEKD |
| K925215 | Sterile Surgical Instrument TraysKDD · Traditional | American Healthcare Supply Co., Inc. | 06/01/1993SEKD |
| K924117 | Dexide Laparoscopic KitsKDD · Traditional | Dexide, Inc. | 03/23/1993SESK |
| K920989 | Surgical Instrument Kit, DisposableKDD · Traditional | Ulti-Med Intl., Inc. | 10/19/1992SEKD |
| K920763 | Lacerattion TrayKDD · Traditional | Sterile Concepts, Inc. | 09/28/1992SESK |
| K920516 | General Purpose Instrument Tray, Sterile, DisposabKDD · Traditional | Trinity Laboratories, Inc. | 04/16/1992SEKD |
| K914244 | Sterile Custom Surgical KitsKDD · Traditional | Ulti-Med Intl., Inc. | 02/24/1992SEKD |
| K913049 | Slip-Pruf-ClingerKDD · Traditional | Macbrud Corp. Medical Div. | 09/11/1991SE |
| K911606 | Baxter Preoperative Skin Prep Tray W/Foam SpongesKDD · Traditional | Baxter Healthcare Corp | 07/09/1991SESK |
| K910816 | In-Sight Surgical Instrument Kits, DisposableKDD · Traditional | Insight International, Inc. | 04/17/1991SESK |
| K910369 | Incision and Drainage KitKDD · Traditional | Megadyne Medical Products, Inc. | 03/28/1991SE |
| K910366 | Mega General Purpose Instrument KitKDD · Traditional | Megadyne Medical Products, Inc. | 03/28/1991SE |
| K902441 | Disposable Procedural Trays #Ck-Xxxxx (Various)KDD · Traditional | Currie Medical Specialties, Inc. | 08/23/1990SEKD |
| K880785 | SkilcraftKDD · Traditional | Pennsylvania Association For the Blind | 03/11/1988SE |
| K874063 | Enteron Abdominal Paracentesis TrayKDD · Traditional | Endovations | 12/04/1987SESD |
| K871458 | Survival Kit, Individual, Trop, Tactical Air CrewKDD · Traditional | Fraass Survival Systems, Inc. | 07/09/1987SE |
| K870373 | Sterile Procedural TraysKDD · Traditional | Dimed, Intl. | 03/20/1987SESD |
| K864969 | JMS Halo Application TrayKDD · Traditional | Jerome Medical | 02/18/1987SESD |
| K853910 | Suture Removal KitKDD · Traditional | Scientific & Medical Care Co. | 10/08/1985SE |
| K843206 | Cook County Hospital Dressing Change SetKDD · Traditional | Geneva Laboratories, Inc. | 05/24/1985SE |
| K850325 | Sterile Suture Removal KitKDD · Traditional | Excel Health Care Products | 02/26/1985SE |
| K842627 | C-Section TrayKDD · Traditional | Deroyal Industries, Inc. | 09/26/1984SE |
| K843115 | Sterile Solution BowlKDD · Traditional | E.M. Adams | 09/07/1984SE |
| K834135 | Sterile Suture BootsKDD · Traditional | Devon Industries, Inc. | 04/27/1984SE |
| K833438 | Prepacell-Sterile-Bone Marrow AspirKDD · Traditional | Applied Medical Devices, Inc. | 02/09/1984SE |
| K832628 | Vygon Thoracic Drainage-Various #'SKDD · Traditional | Exco, Inc. | 01/30/1984SE |
| K833075 | Wet Dressing KitKDD · Traditional | Clinipad Corp. | 01/27/1984SE |
| K834532 | Sterile Wet Dressing PackKDD · Traditional | W.G. Whitney Corp. | 01/25/1984SE |
| K831841 | Sterile Disp. Instrument TraysKDD · Traditional | E.M. Adams | 12/14/1983SE |
| K832047 | Sterile Suture Removal SetKDD · Traditional | Ormed Mfg., Inc. | 09/12/1983SE |
| K831795 | First Aid KitsKDD · Traditional | I M, Inc. | 09/01/1983SE |
| K830374 | Rescue PackKDD · Traditional | Akla, Inc. | 05/13/1983SE |
| K822158 | Open Heart Tray (Custom Designed)KDD · Traditional | Megaplast, Inc. | 10/13/1982SE |
| K821814 | Hemo-Nate L-P KitKDD · Traditional | Int'L Corp. | 07/09/1982SE |
| K821502 | Sterile Suture Removal KitKDD · Traditional | Pro-Pak | 07/09/1982SE |
| K821500 | Sterile Cath Care KitKDD · Traditional | Pro-Pak | 06/23/1982SE |
| K821501 | Sterile Tracheostomy Care KitKDD · Traditional | Pro-Pak | 06/16/1982SE |
| K820423 | Suture Removal TrayKDD · Traditional | Megaplast, Inc. | 03/10/1982SE |
| K813103 | Ackrad Incision & Drain SetKDD · Traditional | Ackrad Laboratories | 12/09/1981SE |
| K811855 | Skin Scrub KitsKDD · Traditional | Oem Medical Div. | 07/31/1981SE |
| K811086 | Suture Removal Set(Displsable)KDD · Traditional | Cunningham Woodland, Inc. | 05/01/1981SE |
| K803199 | Suture Removal KitKDD · Traditional | Walpak Co. | 01/15/1981SE |
| K803119 | Large Wound Dressing KitKDD · Traditional | American Medical Disposable, Inc. | 12/30/1980SE |
| K803117 | Custom Dressing Tray Wet to DryKDD · Traditional | American Medical Disposable, Inc. | 12/23/1980SE |
| K803118 | Simple Dressing Tray #82028KDD · Traditional | American Medical Disposable, Inc. | 12/22/1980SE |
| K802557 | Emergency Department Laceration Kit-KDD · Traditional | Johnson & Johnson Professionals, Inc. | 11/12/1980SE |
| K802017 | Dressing Change Set CAT.#910-930KDD · Traditional | Pollak (Intl.), Ltd. | 10/10/1980SE |
| K802019 | Suture Removal Set CAT.#906KDD · Traditional | Pollak (Intl.), Ltd. | 09/16/1980SE |
| K780488 | Instrument and Accessory KitKDD · Traditional | American Hospital Supply Corp. | 04/12/1978SE |
| K780336 | Urine Sample KitKDD · Traditional | American Hospital Supply Corp. | 04/03/1978SE |
| K771448 | Sterile Suture Removal KitKDD · Traditional | Premium Plastics, Inc. | 09/06/1977SE |
| K770149 | Major Suture Removal TrayKDD · Traditional | Pharmaseal Div., Baxter Healthcare Corp. | 02/25/1977SE |
| K761193 | Suture Removal KitKDD · Traditional | Superior Plastic Products Corp. | 01/12/1977SE |
| K760051 | Tray, Suture RemovalKDD · Traditional | M-C Ind., Inc. | 08/30/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3138-2026 Class II | AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394BThe convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags… | Windstone Medical Packaging, Inc. | 07/29/2026Open, Classified |
| Z-3069-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-2540-2026 Class II | Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | Medline Industries, LP | 05/21/2026Open, Classified |
| Z-2496-2026 Class II | MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU…During an internal review, Medline identified representative samples did not meet applicable performance… | Medline Industries, LP | 05/04/2026Open, Classified |
| Z-2386-2026 Class I | Description/REF: PARACENTESIS KIT/ASK-00376-JHHLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2026-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | Medline Industries, LP | 03/19/2026Open, Classified |
| Z-1921-2026 Class II | Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994AThe product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction… | Windstone Medical Packaging, Inc. | 03/11/2026Open, Classified |
| Z-1920-2026 Class II | Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction… | Windstone Medical Packaging, Inc. | 03/11/2026Open, Classified |
| Z-1919-2026 Class II | Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction… | Windstone Medical Packaging, Inc. | 03/11/2026Open, Classified |
| Z-2588-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-2100-2026 Class II | Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1398-2026 Class II | Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1252-2026 Class II | Vortex Surgical I2 Injection Kit, VS0500There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | Vortex Surgical Inc. | 12/16/2025Open, Classified |
| Z-1249-2026 Class II | Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit -…There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | Vortex Surgical Inc. | 12/16/2025Open, Classified |
| Z-0520-2026 Class II | MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2)…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | Medline Industries, LP | 09/30/2025Open, Classified |
| Z-1601-2025 Class II | Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | MEDLINE INDUSTRIES, LP - Northfield | 03/03/2025Open, Classified |
| Z-1458-2025 Class I | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as…Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential… | MEDLINE INDUSTRIES, LP - Northfield | 02/21/2025Open, Classified |
| Z-1463-2025 Class II | Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALSMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 02/11/2025Open, Classified |
| Z-0787-2025 Class II | Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | MEDLINE INDUSTRIES, LP - Northfield | 11/21/2024Open, Classified |
| Z-0477-2025 Class II | JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may… | Biomet, Inc. | 10/21/2024Open, Classified |
| Z-0634-2025 Class II | MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | MEDLINE INDUSTRIES, LP - Northfield | 10/09/2024Open, Classified |
| Z-0306-2025 Class II | DeRoyal C-SECTION TRACEPACK, REF 89-9338-06DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke… | DeRoyal Industries Inc | 10/03/2024Open, Classified |
| Z-0149-2025 Class II | Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | MEDLINE INDUSTRIES, LP - Northfield | 09/04/2024Open, Classified |
| Z-2939-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2938-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2937-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2936-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2935-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2934-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2933-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2932-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2931-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2930-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2929-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2928-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2927-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2926-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2925-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2924-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2923-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2922-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2921-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2920-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2919-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2918-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2917-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2916-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2915-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2914-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |
| Z-2913-2024 Class II | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes…Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by… | Beaver Visitec International, Inc. | 07/26/2024Open, Classified |