Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 3,501–3,550 of 7,959
- Class I
Medical Device Recall · March 21, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
- Class I
Medical Device Recall · March 21, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
- Class II
Medical Device Recall · March 21, 2025
Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B; 4) 84MTVE2-US; 5) 84MTVEC-6; 6) 84MTVEC-B; 7) 84MTVEP-B; 8) 84MTVEX-4;Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- Class II
Medical Device Recall · March 21, 2025
Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77791-2MP2XL; 3) 77791-2MPX; 4) 77791-2MPX-HS; 5) 77791-2MPXL; 6) 77796-2MPX; 7) 77796-2MPXL.Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- Class II
Medical Device Recall · March 21, 2025
OEC 3DOEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
- Class I
Medical Device Recall · March 21, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systemsCertain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
- Class I
Medical Device Recall · March 21, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
- Class I
Medical Device Recall · March 21, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
- Class I
Medical Device Recall · March 21, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
- Class I
Medical Device Recall · March 21, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
- Class I
Medical Device Recall · March 21, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
- Class II
Medical Device Recall · March 21, 2025
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventOEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
- Class II
Medical Device Recall · March 21, 2025
Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part # 67MXTX-B; 3) ) Product Code/Part # 67MXXP-B; 4) ) ProductUndeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- Class II
Medical Device Recall · March 21, 2025
Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, Product Code Part NumbersUndeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- Class I
Medical Device Recall · March 21, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
- Class I
Medical Device Recall · March 21, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
- Class I
Medical Device Recall · March 21, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
- Class I
Medical Device Recall · March 21, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
- Class I
Medical Device Recall · March 21, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
- Class II
Medical Device Recall · March 21, 2025
Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automateABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.
- Class II
Medical Device Recall · March 20, 2025
Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablatioDue to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device
- Class II
Medical Device Recall · March 20, 2025
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The Harvesting Cannula has four lumens which house the endoscope,There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limited to the units of VH-4000 and VH-4001 manufactured with ceramic C-Ring, and the ceramic C-Ring was implemented in the Hemopro 2 devices from November 5, 2024, through February 14, 2025.
- Class II
Medical Device Recall · March 20, 2025
GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chromosome 12 baseline shift, which may lead to false positive/negative results, resulting in diagnosis delay, and may lead to delayed treatment of a treatable genetic disorder.
- Class II
Medical Device Recall · March 20, 2025
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemBeckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order in the following scenario: when a reagent blank or calibration is ordered during sample processing and then any of the components (R1 and/or R2) depletes to zero tests, the analyzer will not be able to complete the calibration request, and the calibration order will remain pending. No further calibration orders can be processed for any assays, and the instrument refuses to accept further sample processing order after the existing calibration curves are expired. Although in-process tests will be completed, this error can cause a delay in reporting subsequent test results. No further calibration orders can be processed for any assays which may cause a delay in reporting test results.
- Class II
Medical Device Recall · March 20, 2025
The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.
- Class II
Medical Device Recall · March 19, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Class II
Medical Device Recall · March 19, 2025
Siemens Healthcare Diagnostics Inc
epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 &The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
- Class II
Medical Device Recall · March 19, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Sterile Water, USP, 100mL, REF RDI30295It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Class II
Medical Device Recall · March 19, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001AIt was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Class I
Medical Device Recall · March 19, 2025
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-AdapteLack of sterility assurance for closed suction catheter systems
- Class I
Medical Device Recall · March 19, 2025
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSELack of sterility assurance for closed suction catheter systems
- Class II
Medical Device Recall · March 19, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Class I
Medical Device Recall · March 19, 2025
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece ComponenLack of sterility assurance for closed suction catheter systems
- Class II
Medical Device Recall · March 19, 2025
Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only dMedical device software marketed without FDA clearance .
- Class II
Medical Device Recall · March 19, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Class I
Medical Device Recall · March 19, 2025
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F,Lack of sterility assurance for closed suction catheter systems
- Class II
Medical Device Recall · March 19, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183KIt was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Class I
Medical Device Recall · March 19, 2025
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, ElbowLack of sterility assurance for closed suction catheter systems
- Class I
Medical Device Recall · March 19, 2025
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 FLack of sterility assurance for closed suction catheter systems
- Class II
Medical Device Recall · March 19, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Class II
Medical Device Recall · March 19, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: HAND, REF DYNJ902002JIt was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Class II
Medical Device Recall · March 19, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEKLY VAD, REF DYNDIt was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Class II
Medical Device Recall · March 19, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Class I
Medical Device Recall · March 19, 2025
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, ElbowLack of sterility assurance for closed suction catheter systems
- Class II
Medical Device Recall · March 19, 2025
Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intMedical device software marketed without FDA clearance .
- Class II
Medical Device Recall · March 19, 2025
Siemens Healthcare Diagnostics Inc
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
- Class I
Medical Device Recall · March 19, 2025
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: NLack of sterility assurance for closed suction catheter systems
- Class II
Medical Device Recall · March 18, 2025
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
- Class II
Medical Device Recall · March 18, 2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: NoWhen expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
- Class II
Medical Device Recall · March 18, 2025
Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language), DCF-E2310E3/1¿(German/French dual language), DCF-E2310F3/1¿ (French/English dual languageIt was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).