General Surgery Tray

FDA product code LRO · Class II (moderate risk) · 21 CFR 878.4370 · General, Plastic Surgery

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance

110510(k) clearances
0PMA approvals
1,046recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K213481Medline General Surgery TrayLRO · Traditional Medline Industries, Inc.05/24/2022SE
K212258Medline Cardiovascular Procedure KitLRO · Traditional Medline Industries, Inc.12/03/2021SE
K041080Surgical Drape Kit - D.I.R.R.A. SRLLRO · Traditional D.I.R.R.A. S.R.L.11/30/2004SE
K030721Quick-Tap Paracentesis Tray, Kit & NeedleLRO · Special Ballard Medical Products03/31/2003SE
K023276Amsino Tracheostomy Care TrayLRO · Traditional Amsino International, Inc.12/09/2002SE
K980137Worldwide Medical Technologies Bone Marrow Biopsy Procedure TrayLRO · Traditional Worldwide Medical Technologies, LLC01/30/1998SE
K971061Opportunity Inc. Bone Marrow Biopsy and Aspiration TrayLRO · Traditional Opportunity, Inc.06/11/1997SN
K971062Opportunity Inc. General Purpose TrayLRO · Traditional Opportunity, Inc.06/09/1997SN
K932221Neurological or Crani Trays (Packs)LRO · Traditional Associated Medical Products Co.03/19/1997SE
K970286Presbyterian Linen Services Surgical PacksLRO · Traditional Medline Industries, Inc.03/10/1997SE
K970187Runyon Large Volume Paracentesis KitLRO · Traditional Gi Supply02/14/1997SE
K965201O.R. Scrub Prep Tray, Sterile, DisposableLRO · Traditional Trinity Laboratories, Inc.02/14/1997SEKD
K964921Basic Biopsy Tray. Disposable, SterileLRO · Traditional Trinity Laboratories, Inc.01/22/1997SE
K963721Skin Scrub TrayLRO · Traditional Grand Medical Products11/27/1996SE
K963715Debridement Tray, Incision and Drainage TrayLRO · Traditional Grand Medical Products11/27/1996SE
K964011Suction Catheter Tray Product No. 900277LRO · Traditional Customed, Inc.11/25/1996SESK
K963443Prod. No. 02-031 - Laceration TrayLRO · Traditional Continental Medical Laboratories, Inc.10/17/1996SE
K962826Medline Radiology-Diagnostic KitsLRO · Traditional Medline Industries, Inc.09/16/1996SE
K961863Paracentesis TraysLRO · Traditional Tri-Med, Inc.05/28/1996SE
K953083Hospital Laundry Services Surgical PacksLRO · Traditional Hospital Laundry Services05/14/1996SE
K961683JJ Skinner Carekits Minor Surgical Procedure TrayLRO · Traditional J.J. Skinner, Inc.05/10/1996SE
K952539Radiology PacksLRO · Traditional Sterile Concepts, Inc.07/14/1995SE
K951478General and Plastic Surgery PacksLRO · Traditional Sterile Concepts, Inc.06/13/1995SE
K950295Wound Closure/Laceration TrayLRO · Traditional Customed, Inc.04/18/1995SE
K951149Single Use Instrument TrayLRO · Traditional Medcare Custom Packaging, Inc.04/06/1995SESK
K950574Needle/CannulaLRO · Traditional Tri-Med Specialties, Inc.02/24/1995SEKD
K945831Disposable Joint Aspiration/Injection Diagnostic KitLRO · Traditional Micromed Development Corp.01/20/1995SE
K945481Shave Prep KitLRO · Traditional Harding Industries, Inc.12/23/1994SESK
K945160Paracentesis Needles/CannulasLRO · Traditional Tri-Med Specialties, Inc.11/14/1994SE
K944044Chiba Style Biopsy NeedleLRO · Traditional Kormed, Inc.10/03/1994SEKD
K941846Bone Marrow Biopsy TrayLRO · Traditional Kormed, Inc.05/18/1994SE
K925467JJ Skinner Carekits(Tm) Dry/Wet/Gel Skin Scrub KitLRO · Traditional J.J. Skinner, Inc.05/11/1994SEKD
K934688Sterile DesignLRO · Traditional Sterile Design, Inc.03/16/1994SEKD
K935743Instrument TrayLRO · Traditional Cush Medical Products03/03/1994SE
K936117Central Line TrayLRO · Traditional Cush Medical Products03/01/1994SE
K935686Dressing Change TrayLRO · Traditional Cush Medical Products02/25/1994SESK
K935858Mill-Rose Percutaneous Procedural KitLRO · Traditional Mill-Rose Laboratory02/22/1994SEKD
K935740Irrigation TrayLRO · Traditional Cush Medical Products02/22/1994SE
K933137Acu-Suture KitLRO · Traditional Acuderm, Inc.02/22/1994SE
K934028Sterile Dressing Change TrayLRO · Traditional Surgipro, Inc.02/17/1994SEKD
K930270Patient Preoperative Prep Tray, Single UseLRO · Traditional Professional Medical Products, Inc.02/17/1994SE
K935741O.R. Basin Set TrayLRO · Traditional Cush Medical Products02/15/1994SE
K935483E-Z Prep(R) Tray with Hibiclens(R)LRO · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic02/09/1994SE
K931820Carapace Stillwater Bowl SetLRO · Traditional Carapace, Inc.02/07/1994SESK
K934029Sterile Laceration & Debridement TraysLRO · Traditional Surgipro, Inc.02/04/1994SESK
K931760Carapace Packing Gauze TraysLRO · Traditional Carapace, Inc.02/04/1994SESK
K934030Sterile Tracheostomy TrayLRO · Traditional Surgipro, Inc.01/26/1994SEKD
K931758Carapace Wound Dressing Kits & Laceration TraysLRO · Traditional Carapace, Inc.01/26/1994SEKD
K920292Various Kits and TraysLRO · Traditional Professional Medical Products, Inc.01/26/1994SEKD
K931844Custom Procedure Medical Tray or KitLRO · Traditional Custom Medical Products, Ltd.01/25/1994SEKD
K931759Carapace Sterile Gauze TraysLRO · Traditional Carapace, Inc.01/25/1994SESK
K934428Argyle Turkel Safety Pneumothorax Procedure TrayLRO · Traditional Sherwood Medical Co.12/30/1993SEKD
K931673Carapace Cataract TraysLRO · Traditional Carapace, Inc.12/30/1993SEKD
K931824Carapace Instrumlent and Instrument SetsLRO · Traditional Carapace, Inc.12/06/1993SEKD
K932652Tri-Med Paracentesis TrayLRO · Traditional Tri-Med Specialties, Inc.11/24/1993SEKD
K932217Major, Minor, Basin Trays (Packs)LRO · Traditional Associated Medical Products Co.11/15/1993SESK
K932220Lap Choly Trays (Packs)LRO · Traditional Associated Medical Products Co.09/27/1993SESK
K926269Procedure KitLRO · Traditional General Medical Co.08/27/1993SEKD
K930700Medlines Repeat Performance Surgical Pack SystemLRO · Traditional Medline Industries, Inc.07/09/1993SESK
K924468Sterile Instrument Trays/Basin SetsLRO · Traditional Baxter Healthcare Corp07/09/1993SE
K925214Shave Prep Trays (Non-Sterile)LRO · Traditional American Healthcare Supply Co., Inc.07/02/1993SESK
K925216Sterile Skin Scrub TraysLRO · Traditional American Healthcare Supply Co., Inc.06/22/1993SEKD
K914037Medsurg O.R. Procedure TrayLRO · Traditional Medsurg Industries, Inc.06/22/1993SEKD
K922133Hospital Kit SV 105LRO · Traditional Savoy Medical Supply Co., Inc.06/07/1993SESK
K925016Prep Shave Kit (Non-Sterile)LRO · Traditional Customed, Inc.04/26/1993SE
K923600Endo Optiks Value PackLRO · Traditional Endo Optics, Inc.03/23/1993SESK
K920267Dyonics Arthroscopic KitLRO · Traditional Smith & Nephew Dyonics, Inc.03/23/1993SEKD
K922648Ace Custom Surgical PackLRO · Traditional Ace Surgical Supply Co., Inc.03/20/1993SESK
K914036Medsurg Laparoscopy TrayLRO · Traditional Medsurg Industries, Inc.03/18/1992SE
K914174Sterile Disposable Wet Skin Scrub TrayLRO · Traditional Medical Device Inspection Co., Inc.02/24/1992SEKD
K914935Heart Pack IILRO · Traditional Westmark Hospital Supplies01/31/1992SEKD
K913136Laser Endoscope Disc Decompression KitsLRO · Traditional Medical Laser, Inc.11/01/1991SESK
K905459Surgical Procedure Tray/Laparoscopy CholecystectomLRO · Traditional Angiosystems, Inc.04/05/1991SE
K910365Wound Closure KitLRO · Traditional Megadyne Medical Products, Inc.03/28/1991SE
K910368Mega Laceration KitLRO · Traditional Megadyne Medical Products, Inc.03/18/1991SE
K905004Bio-Guard O.R. Scrub Prep TrayLRO · Traditional Network Medical Systems, Inc.02/21/1991SE
K902888Customed Orthopedic IILRO · Traditional Customed, Inc.09/10/1990SE
K902887Customed Arthroscopy PackLRO · Traditional Customed, Inc.09/10/1990SE
K903336Customed Hip PactLRO · Traditional Customed, Inc.08/29/1990SE
K901856Custom Wound Management Kits and TraysLRO · Traditional Medcare Custom Packaging, Inc.08/01/1990SESD
K902293Angiography Drape PackLRO · Traditional Biocor Medical, Inc.07/19/1990SESD
K890658Syringe Injection Gun Delivery KitsLRO · Traditional Gastrotech, Inc.10/03/1989SE
K8952021420 Heel-Stick(Tm) Neonatal Blood Sampling KitLRO · Traditional Transidyne General Corp.09/15/1989SE
K894685Davis+Geck Visaduct KitLRO · Traditional Davis & Geck, Inc.08/22/1989SE
K893814Surgical Instrument Kit, DisposableLRO · Traditional Bioseal08/10/1989SE
K892389Biopsy KitLRO · Traditional I M, Inc.07/17/1989SESD
K890570Skin Scrub KitLRO · Traditional Kit Pak, Inc.05/05/1989SE
K890729Suture Removal KitLRO · Traditional Cypress Medical Products, Ltd.04/17/1989SE
K890726Tracheostomy Care and Cleaning KitsLRO · Traditional Cypress Medical Products, Ltd.03/10/1989SE
K885090Homer Mammalok Localization ShieldLRO · Traditional North American Instrument Corp.02/14/1989SE
K890098Kleen Test O.R. KitLRO · Traditional Kleen Test Products01/24/1989SE
K884093Sterile Disposable Surgical PacksLRO · Traditional Bolden Surgical Products10/19/1988SE
K883250Steri-Clens Wound Care KitLRO · Traditional Absorbent Cotton Co., Inc.08/26/1988SE
K882684Repak Surgical Packs - Gown/Towel/Major/Drape/Bas.LRO · Traditional Standard Textile Co., Inc.08/03/1988SE
K880961Alcon Surgical Procedure PacksLRO · Traditional Alcon Laboratories04/29/1988SE
K881083General Purpose KitLRO · Traditional Med-Dex Intl.04/07/1988SESD
K880942Repak Surgical Pack (Gown,Towel,Major,Drape,Basic)LRO · Traditional Repack Surgical Enterprises, Inc.03/21/1988SE
K874760CK 4900 Series, Gown and Towel PakLRO · Traditional Currie Medical Specialties, Inc.12/10/1987SE
K874439Soft Tissue Anchoring Set KitLRO · Traditional Concept, Inc.11/20/1987SE
K873973Lake Wound Care/Treatment KitLRO · Traditional Lake Medical Products, Inc.11/20/1987SE
K872448Blood Containment PackLRO · Traditional Professional Medical Services11/17/1987SE
K872011Port Access KitsLRO · Traditional The Jarid Group, Inc.07/13/1987SE
K871873Closed Chest Drainage SetLRO · Traditional Gish Biomedical, Inc.07/09/1987SE
K871437Survival Kit, IndividualLRO · Traditional Fraass Survival Systems, Inc.07/09/1987SE
K871434Medical Packet, Individual Survival Kit, Airman'sLRO · Traditional Fraass Survival Systems, Inc.07/09/1987SE
K871459Survival Kit, Indiv Trop Tact Air Crew/Plastic BagLRO · Traditional Frass Survival Systems, Inc.06/05/1987SESD
K871322Advanced Medical Systems, KitLRO · Traditional The Jarid Group, Inc.05/27/1987SE
K854292Medsurg Arthrogram TrayLRO · Traditional Medsurg Industries, Inc.11/26/1985SE
K854095Biopsy Tray I & IILRO · Traditional North Coast Medi-Tek11/25/1985SESD
K842648General Surgery TrayLRO · Traditional Deroyal Industries, Inc.09/20/1984SE

Recalls

RecallProductFirmInitiated
Z-3124-2026 Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A…The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur… Medline Industries, LP08/11/2026Open, Classified
Z-3229-2026 Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK…Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the… Medline Industries, LP08/10/2026Open, Classified
Z-3153-2026 Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject… AVID Medical, Inc.08/10/2026Open, Classified
Z-3209-2026 Convenience kits MYRINGOTOMY PACK-LF DYNJ59097AKits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not… Medline Industries, LP07/31/2026Open, Classified
Z-3095-2026 Class IIPresource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… Cardinal Health 200, LLC07/29/2026Open, Classified
Z-3137-2026 Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008NThe kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile… Medline Industries, LP07/23/2026Open, Classified
Z-3261-2026 Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1…Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete… AVID Medical, Inc.07/22/2026Open, Classified
Z-3260-2026 Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1…Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete… AVID Medical, Inc.07/22/2026Open, Classified
Z-3194-2026 Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1…Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with… AVID Medical, Inc.07/22/2026Open, Classified
Z-3070-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… Medline Industries, LP07/20/2026Open, Classified
Z-3109-2026 Class IIHalyard IV Start Kit Non-Sterile REF: KRIV26-02Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility… AVID Medical, Inc.07/14/2026Open, Classified
Z-3108-2026 Halyard IV START KIT NON-STERILE REF: KRIV26-02Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are… AVID Medical, Inc.07/14/2026Open, Classified
Z-2942-2026 Class IICardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… Cardinal Health 200, LLC07/14/2026Open, Classified
Z-3024-2026 Class IIMedline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer Medline Industries, LP07/10/2026Open, Classified
Z-3011-2026 Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural… AVID Medical, Inc.07/09/2026Open, Classified
Z-3010-2026 Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural… AVID Medical, Inc.07/09/2026Open, Classified
Z-3009-2026 Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural… AVID Medical, Inc.07/09/2026Open, Classified
Z-3008-2026 Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural… AVID Medical, Inc.07/09/2026Open, Classified
Z-3007-2026 Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural… AVID Medical, Inc.07/09/2026Open, Classified
Z-3006-2026 Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural… AVID Medical, Inc.07/09/2026Open, Classified
Z-3005-2026 Class IIBrand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR…Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural… AVID Medical, Inc.07/09/2026Open, Classified
Z-2995-2026 Class IIMedline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU…Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and… Medline Industries, LP07/08/2026Open, Classified
Z-2818-2026 Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack…Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions… Windstone Medical Packaging, Inc.06/17/2026Open, Classified
Z-3054-2026 Class IIMedline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… Medline Industries, LP06/12/2026Open, Classified
Z-2789-2026 Class IIMedline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU…Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL… Medline Industries, LP06/11/2026Open, Classified
Z-2736-2026 Class IIMedline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which… Medline Industries, LP06/10/2026Open, Classified
Z-2799-2026 Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part…The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific… Windstone Medical Packaging, Inc.06/08/2026Open, Classified
Z-2781-2026 Class IIMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… Medline Industries, LP06/08/2026Open, Classified
Z-2779-2026 Class IIMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… Medline Industries, LP06/08/2026Open, Classified
Z-2764-2026 Class IMEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU…The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in… Medline Industries, LP06/08/2026Open, Classified
Z-2747-2026 Class IMEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640GMedline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits… Medline Industries, LP06/05/2026Open, Classified
Z-2697-2026 Class IIMedline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN…Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has… Medline Industries, LP05/28/2026Open, Classified
Z-2611-2026 Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… Medline Industries, LP05/28/2026Open, Classified
Z-2609-2026 Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… Medline Industries, LP05/28/2026Open, Classified
Z-2622-2026 Class IA M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical…Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of… Windstone Medical Packaging, Inc.05/21/2026Open, Classified
Z-2621-2026 Class IA M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical…Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of… Windstone Medical Packaging, Inc.05/21/2026Open, Classified
Z-2619-2026 Class IA M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical…Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of… Windstone Medical Packaging, Inc.05/21/2026Open, Classified
Z-2541-2026 Class IIMedline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO…The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… Medline Industries, LP05/21/2026Open, Classified
Z-3044-2026 Class IIHalyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01…The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific… AVID Medical, Inc.05/19/2026Open, Classified
Z-2455-2026 Class IMedline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2)…The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP… Medline Industries, LP05/06/2026Open, Classified
Z-2497-2026 Class IIMEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy…During an internal review, Medline identified representative samples did not meet applicable performance… Medline Industries, LP05/04/2026Open, Classified
Z-2408-2026 Class IIHalyard, Towel Six Pack. Kit Code: AMTS70-01.Inadvertent distribution of sealed pouches that had not undergone validated sterilization. AVID Medical, Inc.04/30/2026Open, Classified
Z-2441-2026 Class IIMedline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103D DYNJ67197G…Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… Medline Industries, LP04/27/2026Open, Classified
Z-2440-2026 Class IIMedline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT…Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… Medline Industries, LP04/27/2026Open, Classified
Z-2439-2026 Class IIMedline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM CVC INSERTION…Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… Medline Industries, LP04/27/2026Open, Classified
Z-2424-2026 Class IIMedline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B BIB GENERAL…Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… Medline Industries, LP04/27/2026Open, Classified
Z-2307-2026 Class IIAligned Medical AMS16835 Fluids Kit RXLidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in… Windstone Medical Packaging, Inc.04/27/2026Open, Classified
Z-2236-2026 Class IMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled…Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which… Medline Industries, LP04/10/2026Open, Classified
Z-2066-2026 Class ICustom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes…Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of… Windstone Medical Packaging, Inc.04/02/2026Open, Classified
Z-2147-2026 Class IMedline medical convenience kits, containing Namic Manifold, Labeled as: 1.…Medline has identified the presence of particulate within the fluid path of the Manifolds. Medline Industries, LP03/24/2026Open, Classified