Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 3,851–3,900 of 7,959
- Class II
Medical Device Recall · February 11, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION PACK, Pack Number CVI5065; 4) KTMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
- Class II
Medical Device Recall · February 11, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; 3) ANGIO PACK-LF, Pack Number DYNJ0954970G; 4) ANGIOGRAPHY 6 FRENCH PACK, PackMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
- Class II
Medical Device Recall · February 11, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, PacMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
- Class II
Medical Device Recall · February 11, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328BMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
- Class II
Medical Device Recall · February 11, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
- Class II
Medical Device Recall · February 11, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
- Class II
Medical Device Recall · February 11, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack Number DYNJRA1749Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
- Class II
Medical Device Recall · February 11, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ0968863M; 3) L & D PACK-LF, Pack Number DYNJ0373290N; 4) L&D PACK, Pack NumbMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
- Class II
Medical Device Recall · February 10, 2025
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
- Class II
Medical Device Recall · February 10, 2025
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CECandida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
- Class II
Medical Device Recall · February 10, 2025
Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-1Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or patients with latex sensitivity come into contact with latex, an allergic reaction may occur.
- Class II
Medical Device Recall · February 7, 2025
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary oCatheter manufactured at the incorrect length.
- Class II
Medical Device Recall · February 7, 2025
Jinan Bodor Cnc Machine Co Ltd
Bodor's I series laser cutting machine.The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(1) and 21 CFR 1040.10(f)(2).
- Class II
Medical Device Recall · February 7, 2025
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory Model: 18-50Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
- Class II
Medical Device Recall · February 6, 2025
C-SECTION PACK, Model Nos LLCS44F LLCS44F-01ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991RDevices may have higher than expected amounts of bacterial endotoxin.
- Class II
Medical Device Recall · February 6, 2025
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
THORACIC PACK , Model No UTTC82Y UTTC82AA-01ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
DIAGNOSTIC NEURO IR TRAY , Model No WENE21ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
DELIVERY PACK , Model No SGDV22D-01 SGDV22EACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07BACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
EAR PACK , Model No SFEA12AACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
AV FISTULA , Model No UTAV77TACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
NEURO IR TRAY , Model No WENI56JACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
CYSTO PACK , Model N. HKCY31AACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
BORN ON ARRIVAL KIT , Model No LLBN11BACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41GACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07BACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73HACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
SPINE LUMBAR PACK , Model No UTSL72AA UTSL72ABACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
TOTAL HIP PACK , Model No SMTH06O SMTH06PACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01IACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
LABOR & DELIVERY PACK, Model Nos LLLD19HACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80Possibility for the obturator to break (separate).
- Class II
Medical Device Recall · February 6, 2025
LAPAROSCOPY PACK , Model No SFLA02A SFLA02BACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
CYSTO , Model No SACY80RACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results.
- Class II
Medical Device Recall · February 6, 2025
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, WiredSync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconnected from the ES server; dispensing devices will not receive updated information, which may lead to incorrect therapy, and delay in accessing medication.
- Class II
Medical Device Recall · February 6, 2025
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
CV BASIC PUMP PACK , Model No WECV23DACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.