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Recall Observatory FDA recall evidence

Core noun

Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 1500 of 1581

Evidence Product Join Root cause
device-recall:cfres:192274 BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS Drill Bit, Item # 829029170, 2.5X140MM DRILL], [ALPS Drill Bit, Item # 829032170, 3.5X140MM DRILL], [ALPS Tap, Item # 824150170, 3.5X140MM CORTICAL TAP], [ALPS Guide Pin, Item # 829516150, 1.6X150MM BAYONET TIP GUIDE PIN], [ALPS Guide Pin, Item # 829516151, 1.6X150MM THREADED TIP GUIDE PIN]. Instruments are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton. Official recall number · Z-0812-2022 Under Investigation by firm
device-recall:cfres:191990 SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT Official recall number · Z-0797-2022 Process control
device-recall:cfres:191993 SAFE-T PLUS ATRAUMATIC ADULT LP TRAY Official recall number · Z-0800-2022 Process control
device-recall:cfres:191837 Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044 Official recall number · Z-0651-2022 Labeling mix-ups
device-recall:cfres:191474 Destino Twist 14F (also branded as Guidestar 14F) Official recall number · Z-0646-2022 Process control
device-recall:cfres:190995 NIM TRIVANTAGE EMG Endotracheal Tube Official recall number · Z-0743-2022 Process control
device-recall:cfres:191859 JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240 Official recall number · Z-0765-2022 Packaging process control
device-recall:cfres:191947 (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR ESYST WIDE 3102517 TR CARR. NORMAL/LOWER. LR 3102506 TR CARRIER WIDE/RAISED ML 3102519 TR CARR. LOW.LR 30MM/PAIR 3102511 TR CARRIER NORMAL, LR 3102531 TRAVERSE RL CARRIER STD/RAISED 3102512 TR CARRIER WIDE, LR 3102532 TRAVERSE RL CARRIER WD/RAISED 3102513 TR CARRIER SLIM, LR 3102562 TR CARRIER, PARALLEL/WIDE Official recall number · Z-0783-2022 Nonconforming Material/Component
device-recall:cfres:191894 HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak Official recall number · Z-0745-2022 Process control
device-recall:cfres:191888 PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers. Official recall number · Z-0746-2022 Unknown/Undetermined by firm
device-recall:cfres:192093 Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 Official recall number · Z-0731-2022 Incorrect or no expiration date
device-recall:cfres:191840 HYDRATOME RX 49-30MM/260CM Material Number: M00583010 Official recall number · Z-0764-2022 Packaging process control
device-recall:cfres:191433 GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonance imaging system. Official recall number · Z-0614-2022 Process control
device-recall:cfres:191377 GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system. Official recall number · Z-0594-2022 Process control
device-recall:cfres:191384 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system. Official recall number · Z-0600-2022 Process control
device-recall:cfres:191281 Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482 Official recall number · Z-0579-2022 Other
device-recall:cfres:191273 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482 Official recall number · Z-0571-2022 Other
device-recall:cfres:191432 GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear magnetic resonance imaging system. Official recall number · Z-0613-2022 Process control
device-recall:cfres:191382 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system. Official recall number · Z-0598-2022 Process control
device-recall:cfres:190804 GE Vscan Extend, being sold as "Vscan Extend Dual DICOM" Official recall number · Z-0519-2022 Device Design
device-recall:cfres:191727 Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the sheath. A protector tip on the end of the brush prevent contamination of the sample during the endoscopy procedure. The force required to dislodge the tip from the bristle is greater than to break the brush wire at the handle body. Official recall number · Z-0711-2022 No Marketing Application
device-recall:cfres:191825 QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 4. Negative Control 0243 Lactobacillus acidophilus derived from ATCC 4356 Official recall number · Z-0704-2022 Material/Component Contamination
device-recall:cfres:189087 Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift Official recall number · Z-0681-2022 Component design/selection
device-recall:cfres:191367 Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722029, 722033, 722034, 722036, 722038, 722039. Allura Xper F010 {C+F). 722003 Allura Xper F010/10 722005 Allura Xper F020 722006 Allura Xper F020/10 and F020/20 722008 Allura Xper F010 722010 Altura Xper F010/10 722011 Allura Xper F020 722012 Allura Xper FD20 biplane 722013 Allura Xper FDlO OR Table 722014 Allura Xper FD20 OR Table 722015 Allura Xper FDl0/10 OR Table 722019 Allura Xper FD20 Biplane OR Table 722020 Allura Xper FD10 OR Table 722022 Allura Xper FD20 OR Table 722023 Allura Xper FD10/10 OR Table 722024 Altura Xper FD20 Biplane OR Table 722025 Allura Xper FD10 722026 Allura Xper FD10/10 722027 Altura Xper FD20/10 biplane 722029 Allura Xper FD10 OR Table 722033 Allura Xper FD10/10 OR Table 722034 Allura Xper FD20/10 OR Table 722036 Allure Xper F020/20 722038 Altura Xper FD20/20 biplane OR Table 722039 Official recall number · Z-0724-2022 Process control
device-recall:cfres:170427 Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper / hypothermia blanket under the patient to provide warming through conductive heat transfer. Official recall number · Z-0825-2019 Device Design

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