💊 Drugs Class I - Dangerous
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
All Recalls
95,094 total recalls in our database
💊 Drugs Class I - Dangerous
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
💊 Drugs Class I - Dangerous
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
💊 Drugs Class I - Dangerous
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
💊 Drugs Class I - Dangerous
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
💊 Drugs Class I - Dangerous
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
💊 Drugs Class I - Dangerous
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine.
The Anspach Effort
🏥 Medical Devices Class I - Dangerous
The graphics at the attachment interface indicating locked and unlocked position are reversed.
🏥 Medical Devices Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
WalkMed Infusion
🏥 Medical Devices Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model 300000) and Unapproved Changes to the Intended Use of the Triton FP Infusion Pump (model 400000).
🏥 Medical Devices Class I - Dangerous
Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.
🏥 Medical Devices Class I - Dangerous
Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed.
🏥 Medical Devices Class I - Dangerous
A variation in flute depth on the routers was observed. The variation in flute depth may cause the routers to be more susceptible to breakages. Risk to Health: Injury to critical soft tissue requiring surgical intervention may occur.
🏥 Medical Devices Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
🏥 Medical Devices Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
WalkMed Infusion
🏥 Medical Devices Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model 300000) and Unapproved Changes to the Intended Use of the Triton FP Infusion Pump (model 400000).
🏥 Medical Devices Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
cobas¿ Liat¿ Analyzer
Roche Molecular Systems
🏥 Medical Devices Class I - Dangerous
Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.
Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASIN SET LAPAROSCOPIC BASIN TRAY
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Kits from Centurion contain a Medtronic/Covidien Light Glove that is being recalled by the manufacturer, Medtronic. According to the notice received from Medtronic, the recall was initiated because some light covers may have splits or holes, which may result in the transfer of microorganisms from the light handle into the patient wound.
Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Inter chlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.