Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 3,051–3,100 of 8,689
- Class II
Medical Device Recall · September 8, 2025
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 8, 2025
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 8, 2025
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 8, 2025
ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 8, 2025
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint ComboDue to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
- Class II
Medical Device Recall · September 8, 2025
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 8, 2025
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70SPort weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 8, 2025
ChemoLock Bag Spike, 01 units REF: CL-10-10Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 8, 2025
ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 8, 2025
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 8, 2025
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 8, 2025
ICU Medical ChemoLock Closed Vial Spike REF: CL-80Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 8, 2025
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NSPort weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 8, 2025
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 8, 2025
ICU Medical ChemosafeLock Connecter REF: KL-FNU3Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 8, 2025
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 8, 2025
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 8, 2025
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 8, 2025
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
Medical Device Recall · September 6, 2025
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-iPotential for compromised integrity of the sterile packaging.
- Class II
Medical Device Recall · September 6, 2025
C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surPotential for compromised integrity of the sterile packaging.
- Class III
Medical Device Recall · September 5, 2025
Philips OMNI II TEE Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · September 5, 2025
Philips S5-2 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class II
Medical Device Recall · September 5, 2025
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a componentDue to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- Class II
Medical Device Recall · September 5, 2025
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male dDue to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.
- Class II
Medical Device Recall · September 5, 2025
Wipro GE Healthcare Private Ltd.
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tubeCarescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.
- Class III
Medical Device Recall · September 5, 2025
Philips X3-1 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · September 5, 2025
Philips Mini Multi TEE Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · September 5, 2025
Philips L12-5 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · September 5, 2025
Philips L17-5 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · September 5, 2025
Philips 3D6-2 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · September 5, 2025
Philips OMNI III TEE Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · September 5, 2025
Philips C9-4 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class II
Medical Device Recall · September 5, 2025
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/maleDue to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.
- Class II
Medical Device Recall · September 5, 2025
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
- Class II
Medical Device Recall · September 5, 2025
Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a comDue to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- Class II
Medical Device Recall · September 5, 2025
Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED401Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.
- Class III
Medical Device Recall · September 5, 2025
Philips X7-2 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class II
Medical Device Recall · September 5, 2025
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/maleDue to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.
- Class II
Medical Device Recall · September 5, 2025
Wipro GE Healthcare Private Ltd.
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tubeCarescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.
- Class III
Medical Device Recall · September 5, 2025
Philips S4-1 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class II
Medical Device Recall · September 5, 2025
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a componentDue to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- Class II
Medical Device Recall · September 4, 2025
American Contract Systems Inc.
Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KITIdentified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
- Class II
Medical Device Recall · September 4, 2025
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob. The stent is used with a primary distal embolic protection device.
- Class II
Medical Device Recall · September 4, 2025
American Contract Systems Inc.
Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROSCOPY PACK - 205958, FYLA38E LAPCHOLAPPY PACK, IHIdentified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
- Class II
Medical Device Recall · September 4, 2025
American Contract Systems Inc.
Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DELIVERY EVBH28D BIRTHING ROOM PACK UPVD01K VAGINAL DELIdentified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
- Class II
Medical Device Recall · September 4, 2025
American Contract Systems Inc.
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS90G TOTAL SHPULDER PACK HGHI26G HIP PINNING PACKIdentified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
- Class II
Medical Device Recall · September 4, 2025
American Contract Systems Inc.
Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 SFLM54AB LAMINECTOMY PACK - 219659 UDLM94AA LAMINECTOIdentified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
- Class II
Medical Device Recall · September 4, 2025
American Contract Systems Inc.
Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
- Class II
Medical Device Recall · September 4, 2025
American Contract Systems Inc.
Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.