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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 1522 of 1581

Evidence Product Join Root cause
device-recall:cfres:173676 SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL3.0, .070", REF SA6SAL30. for cardiovascular use Official recall number · Z-2720-2019 Component design/selection
device-recall:cfres:173711 SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.0, .070", REF SA6CHAMP30. for cardiovascular use Official recall number · Z-2749-2019 Component design/selection
device-recall:cfres:173507 SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL20. for cardiovascular use Official recall number · Z-2623-2019 Component design/selection
device-recall:cfres:172081 SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 110CM, 070", REF SA6JL40A. for cardiovascular use Official recall number · Z-2589-2019 Component design/selection
device-recall:cfres:173638 SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5 SH, .070", REF SA6JL45SH. for cardiovascular use Official recall number · Z-2686-2019 Component design/selection
device-recall:cfres:165789 Duo-Flow XTP Straight Full Set, RMS02105 RMS02108 Official recall number · Z-2937-2018 Process control
device-recall:cfres:166577 remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702 Official recall number · Z-3018-2018 Under Investigation by firm
device-recall:cfres:166054 Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. Official recall number · Z-2782-2018 Employee error
device-recall:cfres:165287 AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium Official recall number · Z-2912-2018 Package design/selection
device-recall:cfres:166164 GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems Official recall number · Z-2954-2018 Nonconforming Material/Component
device-recall:cfres:166484 Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765 Official recall number · Z-2962-2018 Equipment maintenance
device-recall:cfres:166290 Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 320 mm, Item Number: 814311320 Official recall number · Z-3058-2018 Under Investigation by firm
device-recall:cfres:166421 Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 320 mm, Item Number: 814613320 Official recall number · Z-3166-2018 Under Investigation by firm
device-recall:cfres:166303 Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 340 mm, Item Number: 814313340 Official recall number · Z-3071-2018 Under Investigation by firm
device-recall:cfres:166402 Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 360 mm, Item Number: 814609360 Official recall number · Z-3149-2018 Under Investigation by firm
device-recall:cfres:166287 Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm, Item Number: 814311180 Official recall number · Z-3055-2018 Under Investigation by firm
device-recall:cfres:166316 Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 360 mm, Item Number: 814409360 Official recall number · Z-3083-2018 Under Investigation by firm
device-recall:cfres:166369 Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SBC, BRUSH, CLEANING, SINGLE END - 500 EA/CS, 50 EA/BX, 10 BX/CS Official recall number · Z-3210-2018 Under Investigation by firm
device-recall:cfres:165996 Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. Official recall number · Z-2757-2018 Employee error
device-recall:cfres:166957 Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Official recall number · Z-3222-2018 Device Design
device-recall:cfres:166984 Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Official recall number · Z-3236-2018 Device Design
device-recall:cfres:166441 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD Official recall number · Z-3203-2018 Nonconforming Material/Component
device-recall:cfres:166987 Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Official recall number · Z-3239-2018 Device Design
device-recall:cfres:166048 Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. Official recall number · Z-2778-2018 Employee error
device-recall:cfres:165916 DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries Official recall number · Z-2971-2018 Component change control

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