Core noun
Device recall evidence
Joined enrichment rows that support device recall linkage and root-cause wording.
Indexed record set
39,516 evidence rows
-
- Evidence
- device-recall:cfres:213512
- Product
- Apo B Reagent, REF: OSR6143
- Join
- Official recall number ·
Z-1815-2025 - Root cause
- Error in labeling
-
- Evidence
- device-recall:cfres:213421
- Product
- Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
- Join
- Official recall number ·
Z-1760-2025 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:213159
- Product
- IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
- Join
- Official recall number ·
Z-1688-2025 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:213292
- Product
- Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
- Join
- Official recall number ·
Z-1712-2025 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:213352
- Product
- myQA iON; Article Number: MQ10-000;
- Join
- Official recall number ·
Z-1703-2025 - Root cause
- Software design
-
- Evidence
- device-recall:cfres:213368
- Product
- Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
- Join
- Official recall number ·
Z-1719-2025 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:213359
- Product
- Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
- Join
- Official recall number ·
Z-1694-2025 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:213306
- Product
- GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.
- Join
- Official recall number ·
Z-1629-2025 - Root cause
- Device Design
-
- Evidence
- device-recall:cfres:213568
- Product
- SmartPath to dStream for 3.0T, Model Number: 782145;
- Join
- Official recall number ·
Z-1783-2025 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:213476
- Product
- Intera 1.5T Power/Pulsar, Model Number: 781105;
- Join
- Official recall number ·
Z-1778-2025 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:213477
- Product
- Intera 1.5T R11, Model Number: 781170;
- Join
- Official recall number ·
Z-1779-2025 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:213887
- Product
- Product Name: Ingenia 3.0T CX; Model Number: 781271;
- Join
- Official recall number ·
Z-1800-2025 - Root cause
- Software design
-
- Evidence
- device-recall:cfres:213718
- Product
- Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
- Join
- Official recall number ·
Z-1886-2025 - Root cause
- Packaging
-
- Evidence
- device-recall:cfres:213439
- Product
- Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than 1 hour. The Glidewell HT" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement. The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent drills in the placement of a dental implant. The large Twist Drill is stepped to accmmodate the tapered design of the implant and is available in lengths corresponding to the availble implant lengths. Drill length is calculated to indicate where the top of the implant will reside when fully seated to that depth. The Twist Drill is machined from stainless steel.
- Join
- Official recall number ·
Z-1856-2025 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:213592
- Product
- ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
- Join
- Official recall number ·
Z-1843-2025 - Root cause
- Storage
-
- Evidence
- device-recall:cfres:213457
- Product
- DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
- Join
- Official recall number ·
Z-1860-2025 - Root cause
- Device Design
-
- Evidence
- device-recall:cfres:213586
- Product
- HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
- Join
- Official recall number ·
Z-1839-2025 - Root cause
- Storage
-
- Evidence
- device-recall:cfres:213594
- Product
- ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
- Join
- Official recall number ·
Z-1844-2025 - Root cause
- Storage
-
- Evidence
- device-recall:cfres:213599
- Product
- ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
- Join
- Official recall number ·
Z-1849-2025 - Root cause
- Storage
-
- Evidence
- device-recall:cfres:214162
- Product
- GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system
- Join
- Official recall number ·
Z-2030-2025 - Root cause
- Software design (manufacturing process)
-
- Evidence
- device-recall:cfres:214202
- Product
- My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
- Join
- Official recall number ·
Z-2042-2025 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:214026
- Product
- Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA
- Join
- Official recall number ·
Z-2010-2025 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:214016
- Product
- PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
- Join
- Official recall number ·
Z-2025-2025 - Root cause
- Process design
-
- Evidence
- device-recall:cfres:214048
- Product
- Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
- Join
- Official recall number ·
Z-1914-2025 - Root cause
- Process design
-
- Evidence
- device-recall:cfres:213543
- Product
- Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.
- Join
- Official recall number ·
Z-1897-2025 - Root cause
- Process control