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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 51 of 1581

Evidence Product Join Root cause
device-recall:cfres:202450 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00 Official recall number · Z-2347-2023 Device Design
device-recall:cfres:200920 ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery. Official recall number · Z-2274-2023 Nonconforming Material/Component
device-recall:cfres:201943 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB PACK, Model Number: DYNJ58351A; b. PV CAROTID PACK, Model Number: DYNJ63341B; Official recall number · Z-2337-2023 Nonconforming Material/Component
device-recall:cfres:202493 TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail Official recall number · Z-2443-2023 Process control
device-recall:cfres:202394 PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical Official recall number · Z-2458-2023 Under Investigation by firm
device-recall:cfres:202526 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. Official recall number · Z-2449-2023 Under Investigation by firm
device-recall:cfres:202536 Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60. Official recall number · Z-2491-2023 Labeling Change Control
device-recall:cfres:198460 Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum and plasma (lithium heparin, sodium heparin, potassium EDTA) using the Atellica CH Analyzer. SMN: 11537222 Official recall number · Z-1271-2023 Under Investigation by firm
device-recall:cfres:202524 LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF, Official recall number · Z-2475-2023 Nonconforming Material/Component
device-recall:cfres:201163 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85, Official recall number · Z-2434-2023 Device Design
device-recall:cfres:201015 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65 Official recall number · Z-2437-2023 Under Investigation by firm
device-recall:cfres:201150 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65 Official recall number · Z-2435-2023 Under Investigation by firm
device-recall:cfres:201847 Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. Material #11515088 Official recall number · Z-2240-2023 Nonconforming Material/Component
device-recall:cfres:201764 FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FRED4017-PMA, FRED4026, FRED4026-PMA, FRED4038-PMA, FRED4508, FRED4508-PMA, FRED4513-PMA, FRED4518-PMA, FRED4528, FRED4528-PMA, FRED4539, FRED4539-CA, FRED4539-PMA, FRED5009, FRED5009-PMA, FRED5014-PMA, FRED5019-PMA, FRED5029, FRED5029-CA, FRED5029-PMA, FRED5514-CA, FRED5514-PMA, FRED5526-CA, FRED5526-PMA, MV-F351127, MV-F352427, MV-F401227, MV-F401727, MV-F451327, MV-F500927, MV-F501427, MV-F501927, MV-F552627 Official recall number · Z-2238-2023 Process control
device-recall:cfres:199945 Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU only) Official recall number · Z-2243-2023 Under Investigation by firm
device-recall:cfres:201862 Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet & Armboard Covers, Model #ABTSLSAN, 20/case, non-sterile; (2) Microtek/Ecolab/CleanOp Absorbent Table Cover w/Transfer Sheet, Model ABTSLSN, 25/case, non-sterile; Surgical Room Turnover (SRT) Kits: (3) Ecolab Genesys CleanOp Infection Control System, Model ALHS-02, 12/case, non-sterile; (4) Ecolab Genesys CleanOp Infection Control System, Model ALHS-SS-01, 12/case, non-sterile; (5) Ecolab CleanOp Infection Control System, Model BPGN-02, 10/case, non-sterile; (6) Ecolab Genesys CleanOp Infection Control System, Model HFH-02, 12/case, non-sterile; (7) Ecolab Genesys CleanOp Infection Control System, Model HKHA-02, 15/case, non-sterile; (8) Ecolab CleanOp Infection Control System, Model JFKSC-01, 15/case, non-sterile; (9) Ecolab Genesys CleanOp Infection Control System, Model LH-LD-05, 12/case, non-sterile; (10) Ecolab CleanOp Infection Control System, Model NEGM-CV-01D, 9/case, non-sterile; (11) Ecolab Genesys CleanOp Infection Control System, Model PMMC-02D, 12/case, non-sterile; (12) Ecolab Genesys CleanOp Infection Control System, Model PMMC-SP-01D, 12/case, non-sterile; (13) Ecolab Genesys CleanOp Infection Control System, Model SHMC-06, 15/case, non-sterile; (14) Ecolab CleanOp Infection Control System, Model SR-01D, 12/case, non-sterile; (15) Ecolab CleanOp Infection Control System, Model SVB-OSC-01, 12/case, non-sterile; (16) Ecolab CleanOp Infection Control System, Model UCLA-LD-03, 12/case, non-sterile; (17) Ecolab CleanOp Infection Control System, Model VAIC-03, 12/case, non-sterile; and (18) Ecolab Genesys CleanOp Infection Control System, Model VAIC-CP-02, 15/case, non-sterile. Official recall number · Z-2251-2023 Under Investigation by firm
device-recall:cfres:201703 Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266; endoscopic surgical device Official recall number · Z-2428-2023 Nonconforming Material/Component
device-recall:cfres:201696 Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLE, REF SP90-7066; endoscopic surgical device Official recall number · Z-2424-2023 Nonconforming Material/Component
device-recall:cfres:202264 MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700) Official recall number · Z-2397-2023 Under Investigation by firm
device-recall:cfres:202284 Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X) Official recall number · Z-2398-2023 Under Investigation by firm
device-recall:cfres:201999 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP Official recall number · Z-2373-2023 Process control
device-recall:cfres:202083 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611 Official recall number · Z-2386-2023 Process control
device-recall:cfres:202289 MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700) Official recall number · Z-2400-2023 Under Investigation by firm
device-recall:cfres:202206 UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO Official recall number · Z-2364-2023 Process control
device-recall:cfres:201972 HoverMatt, 39" W x 78" L, REF: HM39SPU-B Official recall number · Z-2394-2023 Packaging process control

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