Category

Surgical Devices Recalls

3,817 surgical devices recalls on record from CPSC, FDA, and USDA.

3,817 recalls
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only,...
Surgical Devices·4,812 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumen...
Surgical Devices·11 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEP...
Surgical Devices·33,066 affected·Aug 6, 2021
High RiskFDA
C.r. Bard Inc
Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Surgical Devices·1,140 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Surgical Devices·2,660 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Surgical Devices·33,380 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Surgical Devices·18,060 affected·Aug 5, 2021
High RiskFDA
M.d.l. S.r.l.
General Manual surgical instrument
Surgical Devices·4,120 affected·Aug 5, 2021
High RiskFDA
Mivi Neuroscience Inc
MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, ...
Surgical Devices·68 affected·Jul 23, 2021
High RiskFDA
Mivi Neuroscience Inc
MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm le...
Surgical Devices·491 affected·Jul 23, 2021
CriticalFDA
Cordis Corporation
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
Surgical Devices·45 affected·Jul 21, 2021
CriticalFDA
Cordis Corporation
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
Surgical Devices·26,025 affected·Jul 21, 2021
CriticalFDA
Cordis Corporation
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
Surgical Devices·71,330 affected·Jul 21, 2021
CriticalFDA
Cordis Corporation
Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
Surgical Devices·1,610 affected·Jul 21, 2021
High RiskFDA
W. L. Gore & Associates Inc.
Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", S...
Surgical Devices·3,364 affected·Jul 12, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Steril...
Surgical Devices·152 affected·Jul 9, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommen...
Surgical Devices·178 affected·Jul 9, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recomm...
Surgical Devices·70 affected·Jul 9, 2021
High RiskFDA
Delta Med Spa
NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
Surgical Devices·5,000 affected·Jun 21, 2021
High RiskFDA
Delta Med Spa
NEO DELTA Self Safe, I.V. Catheter REF 3738222
Surgical Devices·10,000 affected·Jun 21, 2021
High RiskFDA
Delta Med Spa
NEO DELTA SELFSAFE PUR T, I.V. Catheter:
Surgical Devices·0 affected·Jun 21, 2021
High RiskFDA
Delta Med Spa
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
Surgical Devices·20,000 affected·Jun 21, 2021
High RiskFDA
Delta Med Spa
DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3...
Surgical Devices·203,680 affected·Jun 21, 2021
High RiskFDA
Delta Med Spa
NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822
Surgical Devices·14,000 affected·Jun 21, 2021
High RiskFDA
Delta Med Spa
WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
Surgical Devices·40,000 affected·Jun 21, 2021
CriticalFDA
Cardinal Health 200, Llc
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Cat...
Surgical Devices·7,197 affected·Jun 16, 2021
High RiskFDA
Medtronic Heart Valves Division
CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
Surgical Devices·67,339 affected·Jun 11, 2021
High RiskFDA
Ge Oec Medical Systems, Inc
OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot im...
Surgical Devices·3 affected·Jun 10, 2021
High RiskFDA
Cordis Corporation
Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introd...
Surgical Devices·680 affected·Jun 9, 2021
High RiskFDA
Simpleware Product Group, Synopsys Northern Europe
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating s...
Surgical Devices·4 affected·Jun 4, 2021
High RiskFDA
Simpleware Product Group, Synopsys Northern Europe
Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/eva...
Surgical Devices·6 affected·Jun 4, 2021
High RiskFDA
Covidien, Lp
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
Surgical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
Surgical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
Surgical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
Surgical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
Surgical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
Surgical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
Surgical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
Surgical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
Surgical Devices·0 affected·May 28, 2021
High RiskFDA
Cardinal Health 200, Llc
Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as ...
Surgical Devices·6,461 affected·May 21, 2021
High RiskFDA
Cardinal Health 200, Llc
Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - Product Usage: intended to be used as protective p...
Surgical Devices·1,638 affected·May 21, 2021
High RiskFDA
Cardinal Health 200, Llc
Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient cove...
Surgical Devices·574 affected·May 21, 2021
High RiskFDA
Cardinal Health 200, Llc
Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - Product Usage: intended to be used as protective patient ...
Surgical Devices·15,360 affected·May 21, 2021
High RiskFDA
Cardinal Health 200, Llc
Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient ...
Surgical Devices·26,250 affected·May 21, 2021
High RiskFDA
Cardinal Health 200, Llc
Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product Usage: intended to be used as protective patient coverings, ...
Surgical Devices·13,426 affected·May 21, 2021
High RiskFDA
Cardinal Health 200, Llc
Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Product Usage: intended to be used as protective patient coveri...
Surgical Devices·5,342 affected·May 21, 2021
High RiskFDA
Bard Access Systems Inc.
5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F Fr...
Surgical Devices·30 affected·May 19, 2021