95,064 total recalls in our database
GE Healthcare
Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Zimmer Biomet
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Zimmer Biomet
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Zimmer Biomet
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Siemens Healthcare Diagnostics
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time. 2. Sample barcodes may be incorrectly read 3. The Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer may not run CEA dilutions at 50x and 100x. The Analyzer may post a Sample Integrity Error when 50x or 100x dilutions are ordered for Carcinoembryonic Antigen (CEA). Dilution factors lower than 50x and neat samples are not affected by this behavior. 4. The Atellica CH 930 Analyzer may continue to display the default reporting units after the reporting units have been changed. 5. The Atellica CH 930 Analyzer may not display results for sample if certain assays are configured to auto-dilute results above or below the assay measuring interval.
Zimmer Biomet
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Cypress Medical Products
Small hole at the end of the syringe is impeding suction of liquid.
Liko AB
The products manufactured on 5/5/17 may be assembled incorrectly. If the incorrectly assembled products is used for patient transport, this could allow the patient to fall, resulting in potential injury to the patient.
Siemens Healthcare Diagnostics
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time. 2. Sample barcodes may be incorrectly read 3. The Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer may not run CEA dilutions at 50x and 100x. The Analyzer may post a Sample Integrity Error when 50x or 100x dilutions are ordered for Carcinoembryonic Antigen (CEA). Dilution factors lower than 50x and neat samples are not affected by this behavior. 4. The Atellica CH 930 Analyzer may continue to display the default reporting units after the reporting units have been changed. 5. The Atellica CH 930 Analyzer may not display results for sample if certain assays are configured to auto-dilute results above or below the assay measuring interval.
Zimmer Biomet
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Terumo Cardiovascular Systems
The service manual was not updated at the time of the release of software version 1.30.
Baxter Healthcare
If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion.
Siemens Healthcare Diagnostics
A potential bias was identified with certain kits compared to the internal standards.
The terminals on the plug may become loose and overheat.
Zimmer Biomet
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Zimmer Biomet
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Zimmer Biomet
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.