Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
CRE Wireguided 12-15mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical...
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
CRE Wireguided 15-18mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
ARTIS icono floor. Model Number: 11327700.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below...
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG12...
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, sur...
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Sy...
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 008017410...
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
CRE Wireguided 6-8mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 ...
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
CRE Wireguided 18-20mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the belo...
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART ...
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESI...
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator...
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Cat...
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
CRE Pro Wireguided 8-10mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOF...
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Medtronic Harmony Delivery Catheter System
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
ARTIS icono biplane. Model Number: 11327600.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.