🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
All Recalls
95,018 total recalls in our database
Due to incomplete seals in the pouch which provide the sterile barrier.
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.
Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;
DAYE (ANNE'S DAY LTD)
🏥 Medical Devices Class I - Dangerous
Product lacks 510(k) clearance.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;
DAYE (ANNE'S DAY LTD)
🏥 Medical Devices Class I - Dangerous
Product lacks 510(k) clearance.
ChemoLock Bag Spike, 01 units REF: CL-10-10
ICU Medical
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.
🏥 Medical Devices Class I - Dangerous
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
🏥 Medical Devices Class I - Dangerous
Potential for contamination with cotton fibers.
🏥 Medical Devices Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
All in One Bundle; Model Number: FG-BNDL-PC-REFAIO;
DAYE (ANNE'S DAY LTD)
🏥 Medical Devices Class I - Dangerous
Product lacks 510(k) clearance.
9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;
DAYE (ANNE'S DAY LTD)
🏥 Medical Devices Class I - Dangerous
Product lacks 510(k) clearance.
🏥 Medical Devices Class I - Dangerous
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
🏥 Medical Devices Class I - Dangerous
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;
DAYE (ANNE'S DAY LTD)
🏥 Medical Devices Class I - Dangerous
Product lacks 510(k) clearance.
9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900;
DAYE (ANNE'S DAY LTD)
🏥 Medical Devices Class I - Dangerous
Product lacks 510(k) clearance.
Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;
DAYE (ANNE'S DAY LTD)
🏥 Medical Devices Class I - Dangerous
Product lacks 510(k) clearance.