General Surgery Tray
General, Plastic Surgery · 21 CFR 878.4370
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
Recent MDR events
20,596 adverse event reports on file
- CONSTELLATION Surgical Procedure PackJul 31, 2026MalfunctionAlcon Research, Llc - Houston1644019-2026-04095
- CONSTELLATION Surgical Procedure PackJul 31, 2026MalfunctionAlcon Research, Llc - Houston1644019-2026-04096
- CONSTELLATION Surgical Procedure PackJul 31, 2026MalfunctionAlcon Research, Llc - Houston1644019-2026-04098
- CENTURION Surgical Procedure PakJul 31, 2026MalfunctionPt. Ciba Vision Batam9681121-2026-00220
- CONSTELLATION Surgical Procedure PackJul 31, 2026MalfunctionAlcon Research, Llc - Houston1644019-2026-04099
- CONSTELLATION Surgical Procedure PackJul 31, 2026MalfunctionAlcon Research, Llc - Houston1644019-2026-04101
- CENTURION ULTRAVIT Probe Procedure PakJul 31, 2026MalfunctionAlcon Research, Llc - Houston1644019-2026-04102
- CENTURION ULTRAVIT Probe Procedure PakJul 31, 2026MalfunctionAlcon Research, Llc - Houston1644019-2026-04103
- CONSTELLATION Surgical Procedure PackJul 31, 2026MalfunctionAlcon Research, Llc - Houston1644019-2026-04104
- CONSTELLATION Surgical Procedure PackJul 31, 2026MalfunctionAlcon Research, Llc - Houston1644019-2026-04106
Event type breakdown
Recalls
1,045 recall events for this product code
- Cardinal Health 200, LLCOpen, ClassifiedAug 13, 2026
Cardinal Health Presource Kits:
Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.
Z-2942-2026 · View FDA record ↗ - Windstone Medical Packaging, Inc.Open, ClassifiedJul 27, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Z-2818-2026 · View FDA record ↗ - Windstone Medical Packaging, Inc.Open, ClassifiedJul 24, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Z-2799-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJul 23, 2026
MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
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.
Z-2764-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJul 23, 2026
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
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 exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Z-2779-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJul 23, 2026
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
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 exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Z-2781-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJul 23, 2026
Medline medical convenience kits labeled as:
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.
Z-2789-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJul 22, 2026
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
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 Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
Z-2747-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJul 15, 2026
Medline Kits containing Zimmer Biomet mixing bowls and spatulas
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 find another readily available device.
Z-2736-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJul 8, 2026
Medline Convenience Kits:
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 its distribution control process.
Z-2697-2026 · View FDA record ↗
Registered firms
208 firms currently registered for this product code
Surgi-serve Llc
Bloomington, IN, US
Dongguan Shin Yi Healthcare Products Factory
DONG GUAN CITY Guangdong, CN
Joykey Industrial (pinghu) Limited
Pinghu City Zhejiang, CN
Sklar Corporation
Malvern, PA, US
Owens & Minor Distribution Inc. Om41
Flower Mound, TX, US
Owens & Minor Distribution Inc. Om45
Sunrise, FL, US
Centurion Medical Products, Lp
Williamston, MI, US
Isomedix Operations Inc
EL PASO, TX, US
Customed, Inc.
Fajardo, PR, US
Trinity Sterile, Inc.
SALISBURY, MD, US
Midwest Sterilization Corp.
JACKSON, MO, US
Nuevo Laredo Directo Al Cliente
Nuevo Laredo Tamaulipas, MX
Lsl Healthcare
Niles, IL, US
Oculus Surgical Inc
Port St Lucie, FL, US
Owens & Minor Distribution Inc. Om30
Kennesaw, GA, US
Isomedix Operations, Inc.
Libertyville, IL, US
Quiroproductos De Cuauhtemoc S. De R.l. De C.v.
Cuauhtemoc Chihuahua, MX
Jiangsu New Pentastar Medical Products Co. Ltd.
Changzhou Jiangsu, CN
Sterigenics Shanghai Eto Ltd.
Shanghai, CN
Environstar Group Company Limited
Hung Yen Province, VN
Alcon Research, Llc
Fort Worth, TX, US
Tri-state De Mexico, S. De R.l. De C.v.
MEXICALI Baja California, MX
Midwest Sterilization Corp.
LAREDO, TX, US
Lianyungang Aiyeh Non-woven Products Co., Ltd.
Lianyungang Jiangsu, CN
Quiroproductos De Cuauhtemoc S. De R.l. De C.v.
CUAUHTEMOC, CHIHUAHUA Mexico, MX
510(k) clearances
110 clearances for this product code
- Medline Industries, Inc.May 24, 2022
K213481 · Medline General Surgery Tray
- Medline Industries, Inc.Dec 3, 2021
K212258 · Medline Cardiovascular Procedure Kit
- D.I.R.R.A. S.R.L.Nov 30, 2004
K041080 · SURGICAL DRAPE KIT - D.I.R.R.A. SRL
- Ballard Medical ProductsMar 31, 2003
K030721 · QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE
- Amsino International, Inc.Dec 9, 2002
K023276 · AMSINO TRACHEOSTOMY CARE TRAY
- Worldwide Medical Technologies, LLCJan 30, 1998
K980137 · WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY
- Opportunity, Inc.Jun 11, 1997
K971061 · OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY
- Opportunity, Inc.Jun 9, 1997
K971062 · OPPORTUNITY INC. GENERAL PURPOSE TRAY