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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 37 of 1581

Evidence Product Join Root cause
device-recall:cfres:207659 Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases. Official recall number · Z-1926-2024 Component design/selection
device-recall:cfres:205901 Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume. Official recall number · Z-1164-2024 Under Investigation by firm
device-recall:cfres:205644 Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG TRUNK STOCK KIT, REF DYKM1880; d) BEDSIDE BRONCH PACK, REF DYKE1601; e) BIOPSY TRAY, REF DYNDH1242; f) BRONCH KIT, REF DYKE1840; g) BRONCHOSCOPY PACK, REF DYNJ37775F; h) BRONCHOSCOPY TRAY, REF DYNDL1350A; i) BRONCHOSCOPY TRAY, REF DYNDL1350AH; j) CAP CHANGE LARGE KIT, REF DYNDA2277A; k) CAP CHANGE LARGE KIT, REF DYNDA2277B; l) DAILY VAD DRIVELINE KIT, REF DYNDC3006; m) DAILY VENT KIT, REF DYNDJ1076; n) DIALYSIS OFF KIT, REF DT21230A; o) DIALYSIS OFF KIT, REF DT20350B; p) DIALYSIS ON KIT, REF DT20355B; q) DOUBLE HUB/CAP CHANGE KIT, REF DYNDC2843; r) DR D CUSTOM PACK, REF DYNJ68068A; s) DR D CUSTOM PACK, REF DYNJ68068B; t) DUODENUM CULTURING PACK, REF DYNJ51294; u) EGD SOUTHEASTERN REG KIT, REF DYKE1830; v) EMERGENCY UMBILICAL INSERTION, REF UVT1165; w) ENDO KIT, REF DYKE1069B; x) ENDO KIT, REF DYKE1475B; y) ERCP ENDO KIT, REF P604360B; z) ERCP SOUTHEASTERN REG KIT, REF DYKM2127; aa) FACIAL PLASTY PACK, REF DYNJ55335D; bb) FIRST YEAR KIT LF, REF EDUC1037; cc) FOLEY BULB INDUCTION KIT, REF MNS13545; dd) G BUNDLE CDS, REF CDS982759; ee) GBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330B; ff) GBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330C; gg) GENERAL/HERNIA PACK, REF DYNJ38541B; hh) GI BRONCHOSCOPY KIT, REF DYKE1254C; ii) HH CAR STOCK IN BIN, REF DYKM1883; jj) IMMERSION 4, REF EDUC05059A; kk) KIT LINE INSERTION, REF CVI4730; ll) KIT, PEG, SOUTHEASTERN REG, REF DYKM2128; mm) LINE INSERT PACK, REF PHS422216004C; nn) MANUAL BLADDER IRRIGATION KIT, REF UROT1051; oo) MANUAL BLADDER IRRIGATION KIT1, REF UROT1051A; pp) MANUAL BLADDER IRRIGATION KIT1, REF UROT1051AH; qq) MOHS KIT, REF DYNDA2072A; rr) MULTI LUMEN CAP CHANGE, REF DYNDA2390A; ss) N HOME CARE WOUND KIT, REF DYK1188079W; tt) NURSE KIT NO LOGO-LF, REF EDUC05036; uu) NURSE TOTE, REF DYKM1872A; vv) NURSING SKILLS, REF EDUC05015A; ww) PICC, REF CDS980470D; xx) PRE OP KIT, REF DYKS1262A; yy) PULMONARY SETUP KIT, REF DYNDA2648; zz) PULMONARY SETUP KIT, REF DYNDA2648H; aaa) REDDY JOINT BATH, REF MMJB001; bbb) REDDY JOINT BATH, REF MMJB001A; ccc) RNSG 1441, REF EDUC1029; ddd) RNSG 1441, REF EDUC1029H; eee) RNSG 2201, REF EDUC1034; fff) RNSG 2201, REF EDUC1034H; ggg) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; hhh) SHEATH REMOVAL TRAY, REF DYNDC1311C; iii) SHORT TERM KIT, REF DYNDC3092; jjj) SINGLE HUB/CAP CHANGE KIT, REF DYNDC2841; kkk) STERILE CAP CHANGE, REF DYNDA2387A; lll) STERILE PREP KIT, REF DYNDA1359; mmm) STERILE PREP KIT, REF DYNDA1359A; nnn) STRL EK SINGLE PACK, REF DYNDA1360B; ooo) SUB PORT ACCESS TRAY, REF DYNDC2768A; ppp) SUPRA PUBIC IRRIGATION TRAY ST, REF DYNDT1019; qqq) SURGICAL PREP KIT, REF DYNJ46340B; rrr) SUTURE KIT, REF M101494; sss) SUTURE TRAY, REF DYNDS1085A; ttt) TRUNK KIT, REF DYKTRUNK1; uuu) TRUNK KIT 1EA, REF DYKM2013; vvv) UMBILICAL VESSEL INSERTION, REF DYNDA3011; www) URINALYSIS KIT, REF DYKM1251; xxx) VAD ACCESS CHANGE KIT, REF DYNDC2882B; yyy) VAD DRESSING KIT A, REF DYNDA2164; zzz) CENTRAL BLOOD CULTURE KIT, REF DYNDH1342B; aaaa) CVC DRESSING CHANGE KIT, REF EBSI1552; bbbb) PORT ACCESS POWER LOC KIT, REF DYNDC1712B; cccc) PORT ACCESS TRAY, REF DYNDC1128B; Official recall number · Z-1111-2024 Nonconforming Material/Component
device-recall:cfres:205922 VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished) Official recall number · Z-1226-2024 Software Design Change
device-recall:cfres:205651 Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF SUT15380; d) LACERATION TRAY W/SNAGFREE NEE, REF SUT19005; e) PLASTICS SUTURE TRAY, REF SUT13535; f) UVC INSERTION TRAY, REF UVT840A g) BRONCHOALVEOLAR LAVAGE PACK, REF DYNDA2369A; h) CENTRAL LINE NEEDLELESS CONNECTOR KIT, REF DYNDC2869B; i) CVC STERILE CAP CHANGE KIT, REF DT20900A; j) DOUBLE VALVE CHANGE KIT, REF DYNDA2660A; k) KIDNEY BIOPSY PACK, REF DYNDH1650; l) PORT ACCESS INFUSION KIT - 0.75IN NEEDLE, REF DYNDC2816C; m) PORT ACCESS KIT, REF EBSI1302A; n) SHORT TERM INFUSAPORT ACCESS KIT, REF DYNDC3188; o) SINGLE VALVE CHANGE KIT, REF DYNDA2659A; p) SUTURE TRAY, REF DYNDS1085A; Official recall number · Z-1112-2024 Nonconforming Material/Component
device-recall:cfres:205661 Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ907794; c) LACERATION TRAY, REF DYNDL1864A; d) OBSTETRICAL, REF DYNJ908877; e) UMC EP VAGINAL DELIVERY, REF DYNJ83093; Official recall number · Z-1122-2024 Nonconforming Material/Component
device-recall:cfres:205713 DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures. Official recall number · Z-1243-2024 Packaging change control
device-recall:cfres:205719 Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170 Official recall number · Z-1133-2024 Nonconforming Material/Component
device-recall:cfres:205924 VITROS XT 7600 Integrated System, Catalog No. 6844461 Official recall number · Z-1228-2024 Software Design Change
device-recall:cfres:205659 Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002 Official recall number · Z-1120-2024 Nonconforming Material/Component
device-recall:cfres:205662 Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) GYN LAPAROSCOPY CDS, REF CDS983913T; d) GYN LAPAROSCOPY CDS, REF CDS983913U; e) GYN LAPAROSCOPY CDS, REF CDS983913V Official recall number · Z-1123-2024 Nonconforming Material/Component
device-recall:cfres:205765 Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S Acu-Loc VDU Plate Standard, Right; 70-0047 Acu-Loc VDU Plate Long, Left; 70-0047-S Acu-Loc VDU Plate Long, Left; 70-0048 Acu-Loc VDU Plate Long, Right; 70-0048-S Acu-Loc VDU Plate Long, Right; 70-0055 Acu-Loc Dorsal Plate, Standard, left; 70-0055-S Acu-Loc Dorsal Plate, Standard, left; 70-0056 Acu-Loc Dorsal Plate, Standard, Right; 70-0056-S Acu-Loc Dorsal Plate, Standard, Right; 70-0057 Acu-Loc Dorsal Plate, Narrow, Left; 70-0057-S Acu-Loc Dorsal Plate, Narrow, Left; 70-0058 Acu-Loc Dorsal Plate, Narrow, Right; 70-0058-S Acu-Loc Dorsal Plate, Narrow, Right; 70-0331 Divergent Radial Styloid Plate; 70-0331-S Divergent Radial Styloid Plate; 70-0334 Volar Lunate Suture Plate; 70-0334-S Volar Lunate Suture Plate; 70-0335 Dorsal Rim Buttress Plate, Right; 70-0335-S Dorsal Rim Buttress Plate, Right; 70-0336 Dorsal Rim Buttress Plate, Left; 70-0336-S Dorsal Rim Buttress Plate, Left; 70-0337 Dorsal Lunate Plate, Right; 70-0337-S Dorsal Lunate Plate, Right; 70-0338 Dorsal Lunate Plate, Left; Official recall number · Z-1218-2024 No Marketing Application
device-recall:cfres:205714 DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures. Official recall number · Z-1244-2024 Packaging change control
device-recall:cfres:205916 RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S Official recall number · Z-1238-2024 Process control
device-recall:cfres:205912 VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished) Official recall number · Z-1224-2024 Software Design Change
device-recall:cfres:214063 STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families. Official recall number · Z-1993-2025 Under Investigation by firm
device-recall:cfres:213508 Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GT-019 (MT26403-4) , STK-GT-100 (MT26403-2), STK-GT-109 (MT26403-2) , STK-GT-113 (MT26403-3) Official recall number · Z-1944-2025 Nonconforming Material/Component
device-recall:cfres:214095 Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250 Official recall number · Z-1995-2025 Under Investigation by firm
device-recall:cfres:213268 GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups. Official recall number · Z-1731-2025 Process control
device-recall:cfres:213396 Artix MT Thrombectomy Device, REF: 32-102 Official recall number · Z-1728-2025 Labeling Change Control
device-recall:cfres:213282 CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH, 1/EA 21-2111-0403-78 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, ENGLISH, 1/EA 21-2112-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, FRENCH, 1/EA 21-2112-0403-02 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2111-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA ¿ 21-2111-0300-50 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2112-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, FRENCH 1/EA ¿ 21-2112-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA 21-2112-0300-50 PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA ¿ 21-2101-51 PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.1, CE ENGLISH 1/EA 21-2111-0401-78 PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.2, CE ENGLISH 1/EA ¿ 21-2111-0402-78 PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, ENGLISH 1/EA 21-2111-0400-51 PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, YELLOW, ENGLISH 1/EA ¿ 21-2112-0400-51 PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, CE ENGLISH 1/EA ¿ 21-2111-0401-51 PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, YELLOW, CE ENGLISH 1/EA ¿ 21-2112-0401-51 PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA ¿ 21-2111-0402-51 PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA 21-2112-0402-78 PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA ¿ 21-2112-0402-51 PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA ¿ 21-2111-0100-51 PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA ¿ 21-2112-0100-51 Official recall number · Z-1662-2025 Software design
device-recall:cfres:213279 Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages. Official recall number · Z-1737-2025 Process control
device-recall:cfres:213384 INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter. Official recall number · Z-1724-2025 Under Investigation by firm
device-recall:cfres:213655 ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip. Official recall number · Z-1817-2025 Labeling Change Control
device-recall:cfres:213656 ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip. Official recall number · Z-1818-2025 Labeling Change Control

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