Dialyzer Optiflux 160NRe
Fresenius Medical Care Holdings
Class I - Dangerous
Potential for internal blood leaks due to cracked polyurethane
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) OPEN HEART A&B, REFDYNJ901203D; 6) ACDF-LF, REFDYNJ906681B; 7) ACDF-LF, REFDYNJ906681C.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KIT,SPINE LH, REF DYNJ906448A.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANTERIOR CERVICAL-CORPECTOMY, REF DYNJ904827.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
See DocMan
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
Medtronic Neuromodulation
Class I - Dangerous
Software issues were identified in application version 2.x.
Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4) BURR HOLE SHUNT PACK, REF DYNJ56819F; 5) BURR HOLE SHUNT PACK, REF DYNJ56819G; 6) RO VP SHUNT PACK, REF PHS392834010D; 7) VP SHUNT, REF SYNJ10307A.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class I - Dangerous
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
Medtronic Neuromodulation
Class I - Dangerous
Software issues were identified in application version 2.x.
SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.
Med Michigan Holding
Class I - Dangerous
Incomplete or partial pouch seals, which may result in a breach in the sterility.
Class I - Dangerous
Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.
Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF DYNJ66252A; 5) MAJOR NEURO PACK-LF, REF DYNJ0578916X.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class I - Dangerous
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Baxter Healthcare
Class I - Dangerous
Devices were identified as released after repair without full testing being performed, which includes flow testing.
Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class I - Dangerous
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.