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:214236
- Product
- The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. The box contains 4 vials with 25 microcuvettes in each vial.
- Join
- Official recall number ·
Z-2070-2025 - Root cause
- Storage
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- Evidence
- device-recall:cfres:214809
- Product
- DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.
- Join
- Official recall number ·
Z-2244-2025 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:214816
- Product
- Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
- Join
- Official recall number ·
Z-2265-2025 - Root cause
- Reprocessing Controls
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- Evidence
- device-recall:cfres:214804
- Product
- Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
- Join
- Official recall number ·
Z-2097-2025 - Root cause
- Software design
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- Evidence
- device-recall:cfres:214618
- Product
- One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
- Join
- Official recall number ·
Z-2276-2025 - Root cause
- Process control
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- Evidence
- device-recall:cfres:214407
- Product
- BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
- Join
- Official recall number ·
Z-2179-2025 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:214312
- Product
- TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Join
- Official recall number ·
Z-2093-2025 - Root cause
- Software design
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- Evidence
- device-recall:cfres:214092
- Product
- Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1 Single-Use Bipolar Minifork Stimulation Probe, 90mm, and 1 Green Ground Needle ; REF 1-D-BMF90-5, lot number 050925219, expiration 2028-11-30 I-D-BMF90-5 Stimulated EMG Kit with Hummingbird - Box of 5 Kits - Each Kit Includes: 1 Single-Use Bipolar Minifork Stimuation Probe, 90mm, and 1 Green Ground Needle
- Join
- Official recall number ·
Z-2100-2025 - Root cause
- Process control
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- Evidence
- device-recall:cfres:214321
- Product
- O-arm O2 Imaging System. Mobile X-Ray System.
- Join
- Official recall number ·
Z-2101-2025 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:214308
- Product
- TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Join
- Official recall number ·
Z-2090-2025 - Root cause
- Software design
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- Evidence
- device-recall:cfres:214650
- Product
- Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250
- Join
- Official recall number ·
Z-2157-2025 - Root cause
- Process control
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- Evidence
- device-recall:cfres:214144
- Product
- Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.
- Join
- Official recall number ·
Z-2139-2025 - Root cause
- Packaging change control
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- Evidence
- device-recall:cfres:214150
- Product
- Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Join
- Official recall number ·
Z-2145-2025 - Root cause
- Packaging change control
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- Evidence
- device-recall:cfres:214520
- Product
- Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular¿ system, 28mm femoral heads and all hip stems Component: NA
- Join
- Official recall number ·
Z-2147-2025 - Root cause
- Process control
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- Evidence
- device-recall:cfres:214147
- Product
- Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Join
- Official recall number ·
Z-2142-2025 - Root cause
- Packaging change control
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- Evidence
- device-recall:cfres:214817
- Product
- Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R
- Join
- Official recall number ·
Z-2175-2025 - Root cause
- Software change control
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- Evidence
- device-recall:cfres:214421
- Product
- Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
- Join
- Official recall number ·
Z-2096-2025 - Root cause
- Employee error
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- Evidence
- device-recall:cfres:214352
- Product
- Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee 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-2125-2025 - Root cause
- Packaging change control
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- Evidence
- device-recall:cfres:214348
- Product
- Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component
- Join
- Official recall number ·
Z-2120-2025 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:214283
- Product
- SIGNA Architect AIR
- Join
- Official recall number ·
Z-2131-2025 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:214351
- Product
- VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
- Join
- Official recall number ·
Z-2123-2025 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:214942
- Product
- BostonSight PROSE Lens.
- Join
- Official recall number ·
Z-2191-2025 - Root cause
- Process control
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- Evidence
- device-recall:cfres:214238
- Product
- SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
- Join
- Official recall number ·
Z-2159-2025 - Root cause
- Process control
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- Evidence
- device-recall:cfres:214716
- Product
- LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
- Join
- Official recall number ·
Z-2194-2025 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:214727
- Product
- 3M Ranger Irrigation Fluid Warming Set, REF 24750
- Join
- Official recall number ·
Z-2231-2025 - Root cause
- Device Design