December 18, 2024Medical DevicesFDA
Micro-X Ltd. recalls MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Hazard: Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
December 18, 2024Medical DevicesFDA
Micro-X Ltd. recalls MICRO-X Rover Mobile X-ray System, # MXU-RV35
Hazard: Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
December 18, 2024Medical DevicesFDA
Microline Surgical, Inc. recalls Microscissor Tip (Disposable); Microline Catalog #: 3122.
Hazard: A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
December 18, 2024Medical DevicesFDA
ICU Medical, Inc. recalls ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environment
Hazard: Due to finished goods incorrectly packaged and labeled.
December 18, 2024Medical DevicesFDA
Folsom Metal Products, Inc. recalls Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35m
Hazard: Units were not intended for commercial distribution and inadvertently distributed.
December 18, 2024Medical DevicesFDA
Folsom Metal Products, Inc. recalls DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) con
Hazard: Units were not intended for commercial distribution and inadvertently distributed.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATAR
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS9
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) M
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W;
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432;
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS9
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYN
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MA
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3)
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Refer to RES or lead review memo for complete list of affected reference/catalog numbers
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN P
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2) MAMMOPLASTY-LF, REF CDS983478M; 3) PLASTI
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO BLADDER PACK, REF DYNJ49672
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS76005
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR,
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) OR
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYN
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
December 11, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3
Hazard: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.