Core noun
Device recall evidence
Joined enrichment rows that support device recall linkage and root-cause wording.
Indexed record set
39,516 evidence rows
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- Evidence
- device-recall:cfres:181830
- Product
- Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.
- Join
- Official recall number ·
Z-2543-2020 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:181399
- Product
- Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320
- Join
- Official recall number ·
Z-2455-2020 - Root cause
- Packaging process control
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- Evidence
- device-recall:cfres:181534
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
- Join
- Official recall number ·
Z-2413-2020 - Root cause
- Component design/selection
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- Evidence
- device-recall:cfres:180820
- Product
- BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, abdominal masses, etc.
- Join
- Official recall number ·
Z-2427-2020 - Root cause
- Labeling Change Control
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- Evidence
- device-recall:cfres:181266
- Product
- Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only.
- Join
- Official recall number ·
Z-2436-2020 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:181744
- Product
- CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042084-001 2094504-001 2042084-001-046050 2042084-001-208621 2042084-001-045915 2042084-001-215164 2042084-001-078474 2042084-001-053034 2042084-001-215165 2042084-001-079462 2042084-001-047389 2042084-001-112198 2042084-001-041673 2042084-001-227238 2042084-001-071564 2042084-001-503824 2042084-001-119839 2042084-001-569269 2042084-001-041674 2042084-001-047549 2042084-001-514651 2042084-001-163572 2042084-001-583721 2042084-001-427592 2042084-001-527358 2042084-001-583723 2042084-001-317166 2042084-001-583724 2042084-001-583715 2042084-001-583718 2042084-001-055156 2042084-001-583722 2042084-001-041835 2042084-001-074124 2042084-001-583706 2042084-001-583707 2042084-001-519926 2042084-001-583717 2042084-001-583713 2042084-001-207863 2042084-001-460604 2042084-001-079192 2042084-001-197663 2042084-001-045872 2042084-001-053195 2042084-001-092010 2042084-001-560824 2042084-001-052372 2042084-001-071088 2042084-001-046667 2042084-001-213006 2042084-001-086202 2042084-001-301821 2042084-001-045720 2042084-001-060454 2042084-001-418294 2042084-001-088907 2042084-001-065769 2042084-001-589530 2042084-001-623792 2042084-001-187563 2042084-001-320333 2042084-001-357143 2042084-001-148302 To be provided 2042084-001-082825 2042084-001-057016 2042084-001-153601 2042084-001-161552 2042084-001-140229 2042084-001-611704 2042084-001-626688 2042084-001-389208 2042084-001-657836 2042084-001-225214 2042084-001-503162 2042084-001-477881 2042084-001-316025 2042084-001-046826 2042084-001-245255 2042084-001-196543 2042084-001-557725 2042084-001-505890 2042084-001-218596 2042084-001-336980 2042084-001-524525 2042084-001-600032 2042084-001-529732 2042084-001-195742 2042084-001-195782 2042084-001-573889 2042084-001-573890 2042084-001-573886 2042084-001-573887 2042084-001-195822 2042084-001-195862 2042084-001-048420 2042084-001-065538 2042084-001-055814 2042084-001-341260 2042084-001-149220 2042084-001-079193 2042084-001-229282 2042084-001-629486 2042084-001-058695 2042084-001-061170 2042084-001-629548 2042084-001-080803 2042084-001-596662 2042084-001-250146 2042084-001-202515 2042084-001-515709 2042084-001-579491 2042084-001-505608 2042084-001-065010 2042084-001-619171
- Join
- Official recall number ·
Z-2424-2020 - Root cause
- Software Design Change
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- Evidence
- device-recall:cfres:181531
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
- Join
- Official recall number ·
Z-2410-2020 - Root cause
- Component design/selection
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- Evidence
- device-recall:cfres:181407
- Product
- Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091
- Join
- Official recall number ·
Z-2463-2020 - Root cause
- Packaging process control
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- Evidence
- device-recall:cfres:194257
- Product
- MiniMed 640G Insulin Pump (O.U.S. Version)
- Join
- Official recall number ·
Z-1354-2022 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:194091
- Product
- RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE: +21.00D, Sph: +21.00D.
- Join
- Official recall number ·
Z-1338-2022 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:193521
- Product
- Verigene CDF Nucleic Acid Test, Part No. 30-002-22
- Join
- Official recall number ·
Z-1334-2022 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:194327
- Product
- Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
- Join
- Official recall number ·
Z-1342-2022 - Root cause
- Process control
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- Evidence
- device-recall:cfres:193986
- Product
- MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
- Join
- Official recall number ·
Z-1336-2022 - Root cause
- Labeling Change Control
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- Evidence
- device-recall:cfres:194292
- Product
- Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
- Join
- Official recall number ·
Z-1362-2022 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:194333
- Product
- Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Join
- Official recall number ·
Z-1320-2022 - Root cause
- Process control
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- Evidence
- device-recall:cfres:194332
- Product
- Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Join
- Official recall number ·
Z-1319-2022 - Root cause
- Process control
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- Evidence
- device-recall:cfres:215550
- Product
- Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile
- Join
- Official recall number ·
Z-2548-2025 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:215524
- Product
- Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
- Join
- Official recall number ·
Z-2559-2025 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:215557
- Product
- Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable
- Join
- Official recall number ·
Z-2565-2025 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:215724
- Product
- Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
- Join
- Official recall number ·
Z-2577-2025 - Root cause
- Incorrect or no expiration date
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- Evidence
- device-recall:cfres:213764
- Product
- 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
- Join
- Official recall number ·
Z-2483-2025 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:215646
- Product
- UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
- Join
- Official recall number ·
Z-2574-2025 - Root cause
- Component change control
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- Evidence
- device-recall:cfres:215723
- Product
- Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
- Join
- Official recall number ·
Z-2576-2025 - Root cause
- Incorrect or no expiration date
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- Evidence
- device-recall:cfres:215795
- Product
- Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Join
- Official recall number ·
Z-2634-2025 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:215600
- Product
- BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q6660E-PA00012, 6660E-PA00030, 6660E-PA00041, 6660E-PA00035, 6660E-PA00032, 6660E-PA00031. Software Versions: 1.04.00.01, 01.05.00.01, 01.06.00.01, and 01.06.01.01 The patient monitor is intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
- Join
- Official recall number ·
Z-2622-2025 - Root cause
- Software design