Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Clearest Strep-A Cassette Test. Test to determine the presence of group A strept...
Product not cleared by the FDA.
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal...
Product not cleared by the FDA.
Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catal...
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
GEM Premier 5000; Part No: 00055415011.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5....
Augmentation devices failed bacterial endotoxin testing.
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Num...
Due to pediatric defibrillator electrode delamination
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Pro...
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 56001...
The device does not bear a unique device identifier.
GEM Premier 5000; Part No. 00055415005.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
GEM Premier 5000; Part No. 00055430008.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 36001...
The device does not bear a unique device identifier.
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
DxC 700 AU, REF: B86444, B86446
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment.
GEM Premier 5000 PAK; Part No. 00055407508.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Cat...
Impactor handle may be missing cross-pin
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box...
Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
CLARITY II Laser System; Model No. 1110200210.
Reports of devices sparking/popping and potentially burning patients.
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
GEM Premier 5000; Part No. 00055415008.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.