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:204544
- Product
- Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body
- Join
- Official recall number ·
Z-0649-2024 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:204218
- Product
- 24 BLOOD CULTURE KIT, REF DYNDH1632
- Join
- Official recall number ·
Z-0313-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:203911
- Product
- LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
- Join
- Official recall number ·
Z-0304-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:203717
- Product
- Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, LF-TP.
- Join
- Official recall number ·
Z-0338-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:203712
- Product
- Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
- Join
- Official recall number ·
Z-0335-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:203544
- Product
- Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;
- Join
- Official recall number ·
Z-0317-2024 - Root cause
- Error in labeling
-
- Evidence
- device-recall:cfres:203545
- Product
- Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
- Join
- Official recall number ·
Z-0318-2024 - Root cause
- Error in labeling
-
- Evidence
- device-recall:cfres:203651
- Product
- AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction, is the basis of this assay.
- Join
- Official recall number ·
Z-0309-2024 - Root cause
- Nonconforming Material/Component
-
- Evidence
- device-recall:cfres:203723
- Product
- Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, duodenum, and small intestine) by oral insertion or the lower digestive tract (including the anus, rectum, sigmoid colon, colon, ileocecal valve, and small intestine) by anal insertion. - Model Number: SIF-Q180.
- Join
- Official recall number ·
Z-0343-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:204057
- Product
- Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.
- Join
- Official recall number ·
Z-0604-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:204873
- Product
- LITe Decompression Snake Arm, REF 48080230
- Join
- Official recall number ·
Z-0610-2024 - Root cause
- Nonconforming Material/Component
-
- Evidence
- device-recall:cfres:204644
- Product
- Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
- Join
- Official recall number ·
Z-0616-2024 - Root cause
- Other
-
- Evidence
- device-recall:cfres:203899
- Product
- EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
- Join
- Official recall number ·
Z-0474-2024 - Root cause
- Software design (manufacturing process)
-
- Evidence
- device-recall:cfres:204067
- Product
- Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M, 42A-43H, and 42A-43S. Ceiling mounted utilities and equipment dispensing system.
- Join
- Official recall number ·
Z-0452-2024 - Root cause
- Device Design
-
- Evidence
- device-recall:cfres:203922
- Product
- ProCuity bed series, model number 3009, item number: 3009PX-LEX-450.
- Join
- Official recall number ·
Z-0430-2024 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:204041
- Product
- NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
- Join
- Official recall number ·
Z-0455-2024 - Root cause
- Device Design
-
- Evidence
- device-recall:cfres:203733
- Product
- Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 362033 UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; 362034 Priming volume: 19mL, length: 120in, SafeLine; 362035 INFUSOMAT SPACE PUMP IV SET; 362043 Priming volume: 39mL, length: 120in, SafeLine; 362050 15 drops/mL, priming volume: 26mL, length: 124in, SafeLine; 362420 SPACE PUMP SET 15 DROP W/2 SAFEDAY; 362432 15 drops/mL, priming volume: 21mL, length: 118in, ULTRASITE; 362911 Priming volume: 14mL, length: 84in, CARESITE, Spin-Lock; 363010 Priming volume: 21mL, length: 121in, SafeLine; 363019 Priming volume: 40mL, length: 123in, SafeLine; 363030 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 363032 20 drops/mL, priming volume: 20mL, length: 119in, SafeLine; 363230 15 drops/mL, priming volume: 22mL, length: 123in, ULTRASITE; 363410 15 drops/mL, priming volume: 23mL, length: 119in, CARESITE; 363419 Priming volume: 41mL, length: 120in, CARESITE; 363420 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE; 363421 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 363422 Priming volume: 21mL, length: 130in, CARESITE; 363423 60 drops/mL, priming volume: 21mL, length: 118in, CARESITE; 363424 UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV; 363430 15 drops/mL, priming volume: 23mL, length: 123in, CARESITE; 363433 UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; 363901 60 drops/mL, priming volume: 11mL, length: 129in; 363902 Priming volume: 25mL, length: 130in; 363904 UNIV. 15 DROP PUMP SET, ASV; 470119 15 drops/mL, priming volume: 23mL, length: 119in, CARESITE; 480254 SPACE PUMP IV SET 15D, 110 IN.; 480255 SPACE PUMP IV SET, 127 IN; 480257 60 DROP NITRO SPACE SET, 88 IN.; 480258 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER; 480263 SPACE PUMP IV SET 15D, 90 IN.; 480264 SPACE PUMP IV SET, 15 DRPS/ML, 95 IN.; 490037 Priming volume: 25mL, length: 136in; 490038 60 drops/mL, priming volume: 11mL, length: 129in; 490100 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 490101 Priming volume: 19mL, length: 120in, CARESITE; 490102 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 490103 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE; 490104 60 drops/mL, priming volume: 21mL, length: 115in, CARESITE; 490105 Priming volume: 39mL, length: 120in, CARESITE
- Join
- Official recall number ·
Z-0355-2024 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:204270
- Product
- PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
- Join
- Official recall number ·
Z-0479-2024 - Root cause
- Labeling design
-
- Evidence
- device-recall:cfres:203981
- Product
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
- Join
- Official recall number ·
Z-0459-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:203730
- Product
- Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.
- Join
- Official recall number ·
Z-0407-2024 - Root cause
- Other
-
- Evidence
- device-recall:cfres:203921
- Product
- ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.
- Join
- Official recall number ·
Z-0429-2024 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:202627
- Product
- Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663, MAJ-664, MAJ-665, MAJ-666
- Join
- Official recall number ·
Z-2523-2023 - Root cause
- Nonconforming Material/Component
-
- Evidence
- device-recall:cfres:201609
- Product
- The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
- Join
- Official recall number ·
Z-2104-2023 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:201710
- Product
- Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant
- Join
- Official recall number ·
Z-2120-2023 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:201937
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ905151A; b. ANGIO/VENO PACK, Model Number: DYNJ58346A; c. ANGIOGRAPHIC PACK, Model Number: DYNJ57442C, DYNJ64081A; d. ANGIOGRAPHY PACK, Model Number: DYNJ65963; e. ANGIOPLASTY PACK-LF, Model Number: DYNJ64655; f. ARTHROGRAM TRAY, Model Number: SPEC0232; g. BASIC CATH/ANGIO, Model Number: DYNJ62591A; h. BASIC PACK, Model Number: DYNJ39752A; i. C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B; j. CATH ANGIO PACK, Model Number: DYNJ64050; k. DBD-KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148; l. DBS PACK-LF, Model Number: DYNJ0878178I; m. GENERAL ANGIO PACK, Model Number: DYNJ57760A; n. GHIASSI NEURO ANGIO PACK-LF, Model Number: DYNJ57032C; o. IR NEURO PACK, Model Number: DYNJ39198L, DYNJ39198N; p. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086A; q. MAIN BASIC NEURO, Model Number: DYNJ908260; r. NEURO ACCESSORY PACK, Model Number: DYNJ66790, DYNJ66790A, DYNJ66790B; s. NEURO CATH PACK, Model Number: DYNJ69129, DYNJ83090; t. NEURO IR PACK, Model Number: DYNJ35066I, DYNJ35066J, DYNJ60701A, DYNJ60701B, DYNJ60701C; u. NEURO PACK, Model Number: DYNJ43934A, DYNJ61798D, DYNJ66241, DYNJ66241A, DYNJ66241B, DYNJ66241C, DYNJ66241D, DYNJ68956A, DYNJ68956B; v. NEURO RADIOLOGY PACK, Model Number: DYNJ51107A, DYNJ59903A, DYNJ59903B; w. NEURO TRAY, Model Number: DYNJ67075, DYNJ67075A; x. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112A; y. PEDI ANGIO PACK-LF, Model Number: PHS41743B; z. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755C; aa. RADIOLOGY NEURO DRAPE PAC, Model Number: DYNJ61449; bb. RO-DIEP PACK, Model Number: DYNJ82393A;
- Join
- Official recall number ·
Z-2331-2023 - Root cause
- Nonconforming Material/Component