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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 301–320 of 39,430 recalls

Class IIOngoing

Medline convenience kit: (82)LABOR & DELIVERY C-SECTION DYNJ907895F

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline EBSI Kit EBSI1534

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits: C-SECTION KIT DYNJ904305J C-SECTION PACK DYNJ69533C

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT EBSI1328A

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHOOL AGE PICC DRSG TRAY DYNDC3291

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK DYNJ29135N EP DEVICE DYNJ65916B FULL LINE ANEURYSM CDS CDS983672P GEN FEM POP #14-RF DYNJ21877W IMPLANT PACK DYNJ39316D OPEN HEART MRNGSD DYNJ58354F PACEMAKER PACK-LF DYNJ0618174N PACEMAKER SETUP PACK DYNJ35761D PACER / CATH LAB PACK-LF DYNJ0972604A PACER CDS CDS983686I PACER PACK DYNJ52059D PK, EP LAB PACEMAKER DYNJ43663A VENOUS ACCESS PACK DYNJ45640B

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IOngoing

BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400866, 405672, 405673, 405674, 405675, 405709, 405721, 405723, 406704.

Becton Dickinson & Company

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits: HYSTERECTOMY PACK-LF DYNJ20485L

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IOngoing

BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405621, 405735.

Becton Dickinson & Company

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS SYNJ10306A ENDO BREAST AUGMENTATION PACK DYNJ68023 FACIAL PLASTIC DYNJ909926C JVL - MODULE PLASTIC PK DYNJ84081B KIT MAJOR PLASTICS MOSES DYNJ905362C MEM MAXILLOFACIAL PACK-LF DYNJ0660040R MINOR BREAST PACK DYNJ89023A PLASTIC MAJOR SURGERY DYNJ902510M PLASTIC PACK DYNJ84766 PLASTIC PACK-LF DYNJ0578842M PLASTICS EXTREMITY PACK DYNJ63803C PLASTICS PK - NO SYR DYNJ62433D RR-ASC-RHINOPLASTY PACK-LF DYNJ81772C TRANSGENDER PACK DYNJT7588 WH PLASTIC MAJOR PACK DYNJ89048A

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IIOngoing

PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

Oculus Technologies of Mexico, S.A. de C.V.

The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in the solution during use.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC/CVC/MIDLINE DRSG CHG KIT DT13191A PORT A CATH CDS982047S VEIN ABLATION PACK DYNJ62889C

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IOngoing

BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405741.

Becton Dickinson & Company

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

April 27, 2026 · DeviceView details →
Class IOngoing

BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405658.

Becton Dickinson & Company

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits: C SECTION CDS985505G C SECTION PACK DYNJ68260D C-SECTION DYNJ905094B C-SECTION RECOVERY #2 CDS820091P

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IOngoing

BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405609.

Becton Dickinson & Company

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B BIB GENERAL LAPAROSCOPY PA DYNJ58305 CHRISTUS CH PEDIATRIC BASIC DYNJ61167G CVC INSERTION BUNDLE CVI3940A DAVINCI PACK SURGICOUNT DYNJ45544F EPCH BASIC PACK DYNJ83094C GENERAL PACK DYNJ39682B DYNJ84882 GENERAL RFD DYNJ906336F GENERAL SURGERY PACK DYNJT6003 GV MACD PACK DYNJ46952M IMPLANT PACK - BBI AR DYNJ63508A KIT THORACOSCOPY DYNJ908872F LVAD TRAY DM1120A MAJOR UROLOGY PACK-LF DYNJ0368525M MICRODISECT DECOMPRESS-LF DYNJ911467 MINOR PACK DYNJ86972 MULTI PURPOSE PACK DYNJ58406B OPEN HEART DYNJ903245C P&K PACK DYNJT5838 PACK,PEDIATRIC MAJOR DYNJ906888F PCNL DYNJ904468C PEDIATRIC MINOR RFD DYNJ906296I PEDIATRIC PACK DYNJ54239K PEDIATRIC SURGERY DYNJ81474B PERLMUTTER PACK DYNJT7387 RFT ISC NOBLES MINOR PACK DYNJ43954B ROBOTICS FMOL LADY OF THE LAKE DYNJ89584 ROBOTICS PACK DYNJ83622B SCOLI PACK NTX DYNJ68415C SMALL ABDOMINAL PACK-LF PHS41749G STIM IMPLANT TRIALS DYNJ87790A SUPPLEMENTAL PACK DYNJ65244 TENEX PACK DYNDH2190 THORACIC PACK DYNJ56616G THORACIC PACK SHD DYNJ68416C THORACOSCOPY DYNJ9425843R THORACOTOMY PM DYNJ906815A THORACOTOMY THORACOSCOPY DYNJ902882D TRAY,NEONATAL PICC DRSG CHANGE DYNDC1533B UNIVERSAL-ASC DYNJ900071C

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kit: IV START KIT W/HUBGUARD DYNDV2662

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
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