Ct Biopsy Tray

FDA product code OFG · Class II (moderate risk) · 21 CFR 870.4075 · Cardiovascular

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.

0510(k) clearances
0PMA approvals
25recalls

Recalls

RecallProductFirmInitiated
Z-2539-2026 Class IIMedline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST…The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… Medline Industries, LP05/21/2026Open, Classified
Z-2489-2026 Class IIMEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit…During an internal review, Medline identified representative samples did not meet applicable performance… Medline Industries, LP05/04/2026Open, Classified
Z-2420-2026 Class IIMedline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853LKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… Medline Industries, LP04/27/2026Open, Classified
Z-2018-2026 Class IIMedline 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, LP03/19/2026Open, Classified
Z-1879-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. Medline Industries, LP02/27/2026Open, Classified
Z-1720-2026 Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… Medline Industries, LP02/27/2026Open, Classified
Z-1838-2026 Class IIMedline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543AThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… Medline Industries, LP02/25/2026Open, Classified
Z-2095-2026 Class IIMedline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… Medline Industries, LP01/07/2026Open, Classified
Z-1392-2026 Class IIMedline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… Medline Industries, LP01/07/2026Open, Classified
Z-1189-2026 Class IIMedline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… Medline Industries, LP12/12/2025Open, Classified
Z-0515-2026 Class IIMEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2)…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… Medline Industries, LP09/30/2025Open, Classified
Z-1594-2025 Class IIMedline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… MEDLINE INDUSTRIES, LP - Northfield03/03/2025Open, Classified
Z-1440-2025 Class IIMedline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield02/11/2025Open, Classified
Z-0780-2025 Class IIMedline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… MEDLINE INDUSTRIES, LP - Northfield11/21/2024Open, Classified
Z-0719-2025 Class IIDIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… MEDLINE INDUSTRIES, LP - Northfield11/06/2024Open, Classified
Z-0627-2025 Class IIMEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… MEDLINE INDUSTRIES, LP - Northfield10/09/2024Open, Classified
Z-0158-2025 Class IIMedline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… MEDLINE INDUSTRIES, LP - Northfield09/04/2024Open, Classified
Z-2998-2024 Class IIMedline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield04/08/2024Open, Classified
Z-2746-2024 Class IIMedline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield04/08/2024Open, Classified
Z-2629-2024 Class IIMedline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield04/08/2024Open, Classified
Z-1098-2024 Class IMEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYNDH1679; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… MEDLINE INDUSTRIES, LP - Northfield11/15/2023Open, Classified
Z-2170-2023 Class IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. MEDLINE INDUSTRIES, LP - Northfield05/18/2023Open, Classified
Z-2307-2023 Class IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.…Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. MEDLINE INDUSTRIES, LP - Northfield05/15/2023Open, Classified
Z-1114-2023 Class IISurgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224BThe recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… MEDLINE INDUSTRIES, LP - Northfield12/07/2022Open, Classified
Z-1069-2023 Class IISterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… MEDLINE INDUSTRIES, LP - Northfield11/17/2022Open, Classified