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:210771
- Product
- Acrobat-i Positioner. Model Number C-XP-5000Z
- Join
- Official recall number ·
Z-0484-2025 - Root cause
- Process change control
-
- Evidence
- device-recall:cfres:210530
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
- Join
- Official recall number ·
Z-0373-2025 - Root cause
- Nonconforming Material/Component
-
- Evidence
- device-recall:cfres:210534
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
- Join
- Official recall number ·
Z-0377-2025 - Root cause
- Nonconforming Material/Component
-
- Evidence
- device-recall:cfres:210531
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
- Join
- Official recall number ·
Z-0374-2025 - Root cause
- Nonconforming Material/Component
-
- Evidence
- device-recall:cfres:210742
- Product
- Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.
- Join
- Official recall number ·
Z-0506-2025 - Root cause
- Device Design
-
- Evidence
- device-recall:cfres:210743
- Product
- Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
- Join
- Official recall number ·
Z-0498-2025 - Root cause
- Reprocessing Controls
-
- Evidence
- device-recall:cfres:211382
- Product
- See DocMan
- Join
- Official recall number ·
Z-0788-2025 - Root cause
- Nonconforming Material/Component
-
- Evidence
- device-recall:cfres:211504
- Product
- VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
- Join
- Official recall number ·
Z-0711-2025 - Root cause
- Device Design
-
- Evidence
- device-recall:cfres:211371
- Product
- Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF DYNJ66252A; 5) MAJOR NEURO PACK-LF, REF DYNJ0578916X.
- Join
- Official recall number ·
Z-0777-2025 - Root cause
- Nonconforming Material/Component
-
- Evidence
- device-recall:cfres:211381
- Product
- Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J; 2) NEURO BASIN KIT, REF DYNJ80200B.
- Join
- Official recall number ·
Z-0787-2025 - Root cause
- Nonconforming Material/Component
-
- Evidence
- device-recall:cfres:211107
- Product
- Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.
- Join
- Official recall number ·
Z-0654-2025 - Root cause
- Device Design
-
- Evidence
- device-recall:cfres:211115
- Product
- Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
- Join
- Official recall number ·
Z-0692-2025 - Root cause
- Process change control
-
- Evidence
- device-recall:cfres:211114
- Product
- Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.
- Join
- Official recall number ·
Z-0660-2025 - Root cause
- Device Design
-
- Evidence
- device-recall:cfres:211292
- Product
- HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
- Join
- Official recall number ·
Z-0698-2025 - Root cause
- Nonconforming Material/Component
-
- Evidence
- device-recall:cfres:211123
- Product
- Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
- Join
- Official recall number ·
Z-0668-2025 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:209516
- Product
- Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.
- Join
- Official recall number ·
Z-3095-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:209233
- Product
- Power Express, REF B90918
- Join
- Official recall number ·
Z-2978-2024 - Root cause
- Nonconforming Material/Component
-
- Evidence
- device-recall:cfres:208592
- Product
- Medline Convenience kits labeled as: KIT VASCULAR IVC FILTER PLACEM, Pack Number DYKMBNDL37AH
- Join
- Official recall number ·
Z-2994-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:208173
- Product
- Centurion procedure packs, containing Caina syringes, labeled as: 1) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 2) RETINAL INJECTION KIT, Pack Number MNS12465
- Join
- Official recall number ·
Z-2774-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:209260
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000162;
- Join
- Official recall number ·
Z-2798-2024 - Root cause
- No Marketing Application
-
- Evidence
- device-recall:cfres:209254
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584770;
- Join
- Official recall number ·
Z-2792-2024 - Root cause
- No Marketing Application
-
- Evidence
- device-recall:cfres:209514
- Product
- Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1937CR.
- Join
- Official recall number ·
Z-3093-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:209486
- Product
- ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491379 SMN: 11206239
- Join
- Official recall number ·
Z-3103-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:209678
- Product
- ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
- Join
- Official recall number ·
Z-3097-2024 - Root cause
- Packaging
-
- Evidence
- device-recall:cfres:209694
- Product
- vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for intra-abdominal fluid collections.
- Join
- Official recall number ·
Z-3150-2024 - Root cause
- Packaging process control