GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.
Pyramids Wholesale
💊 Drugs Class I - Dangerous
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
All Recalls
95,114 total recalls in our database
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
ROUTE 92 MEDICAL
🏥 Medical Devices Class I - Dangerous
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
ROUTE 92 MEDICAL
🏥 Medical Devices Class I - Dangerous
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Product was distributed in the United States without proper regulatory approval.
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
Howmedica Osteonics
🏥 Medical Devices Class I - Dangerous
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
Howmedica Osteonics
🏥 Medical Devices Class I - Dangerous
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
Howmedica Osteonics
🏥 Medical Devices Class I - Dangerous
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
🏥 Medical Devices Class I - Dangerous
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
🏥 Medical Devices Class I - Dangerous
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
Howmedica Osteonics
🏥 Medical Devices Class I - Dangerous
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E
Howmedica Osteonics
🏥 Medical Devices Class I - Dangerous
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Ion Beam Applications S.A.
🏥 Medical Devices Class I - Dangerous
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
🏥 Medical Devices Class I - Dangerous
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
🏥 Medical Devices Class I - Dangerous
Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
🏥 Medical Devices Class I - Dangerous
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
🏥 Medical Devices Class I - Dangerous
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the LightStrike Germ-Zapping Robots Models: PXUV4D, PXUV5D, LSMUV6-FT, or LSMUV6-SL, for whole room microbial reduction.
XENEX Disinfection Services
🏥 Medical Devices Class I - Dangerous
Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to a bystander standing in the same room, but on the other side of the curtain from where a microbial reduction device UV cycle is taking place. Bystanders in the room during the cycle may experience temporary skin reddening, feeling of sand in eyes, nausea, headache, and/or mucous membrane irritation.
🏥 Medical Devices Class I - Dangerous
Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.