Category

Surgical Devices Recalls

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

3,817 recalls
CriticalFDA
Covidien Llc
Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Surgical Devices·2,462 affected·Jun 8, 2022
CriticalFDA
Covidien Llc
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Surgical Devices·132,443 affected·Jun 8, 2022
RecallFDA
Synapse Biomedical Inc
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 2...
Surgical Devices·71 affected·May 31, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, with Cover Model Number: DYND12200
Surgical Devices·1 affected·May 25, 2022
High RiskFDA
Cook Incorporated
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Surgical Devices·11,451 affected·May 25, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicated in surgical pr...
Surgical Devices·2 affected·May 25, 2022
RecallFDA
Mckesson Medical-surgical Inc. Corporate Office
Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560.
Surgical Devices·9 affected·May 25, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN0...
Surgical Devices·5 affected·May 25, 2022
RecallFDA
Volcano Corp
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Surgical Devices·14 affected·May 13, 2022
High RiskFDA
Getinge Usa Sales Inc
VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT6...
Surgical Devices·337 affected·May 6, 2022
High RiskFDA
Abbott
FIRMap" Catheter, 60mm Basket
Surgical Devices·40 affected·Apr 28, 2022
High RiskFDA
Bard Peripheral Vascular Inc
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
Surgical Devices·1,460 affected·Apr 22, 2022
High RiskFDA
Stradis Healthcare
Surgical Suture Kit
Surgical Devices·7,340 affected·Apr 22, 2022
High RiskFDA
Baxter Healthcare Corporation
Locking Cap for PD Catheter Adapter
Surgical Devices·75 affected·Apr 21, 2022
High RiskFDA
Medtronic Perfusion Systems
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray...
Surgical Devices·1,236 affected·Apr 20, 2022
High RiskFDA
Turbett Surgical, Inc.
Turbett Surgical Container, TS1500
Surgical Devices·7 affected·Apr 14, 2022
High RiskFDA
Coopersurgical, Inc.
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedure...
Surgical Devices·73 affected·Mar 31, 2022
High RiskFDA
Coopersurgical, Inc.
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography proced...
Surgical Devices·169 affected·Mar 31, 2022
High RiskFDA
Coopersurgical, Inc.
CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingograph...
Surgical Devices·90 affected·Mar 31, 2022
High RiskFDA
Olympus Corporation Of The Americas
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
Surgical Devices·1,386 affected·Mar 31, 2022
High RiskFDA
Restor3d Inc.
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
Surgical Devices·4 affected·Mar 30, 2022
High RiskFDA
Restor3d Inc.
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual...
Surgical Devices·14 affected·Mar 30, 2022
High RiskFDA
Restor3d Inc.
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
Surgical Devices·9 affected·Mar 30, 2022
High RiskFDA
Abbott
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Surgical Devices·588 affected·Mar 24, 2022
High RiskFDA
Abbott
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
Surgical Devices·2,134 affected·Mar 24, 2022
High RiskFDA
Medtronic Vascular, Inc.
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Surgical Devices·3 affected·Mar 23, 2022
High RiskFDA
Medtronic Vascular, Inc.
Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04...
Surgical Devices·6 affected·Mar 23, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Surgical Devices·486,578 affected·Mar 15, 2022
High RiskFDA
Augustine Temperature Management, Llc
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; ...
Surgical Devices·1,113 affected·Mar 14, 2022
High RiskFDA
Augustine Temperature Management, Llc
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model #...
Surgical Devices·17 affected·Mar 14, 2022
High RiskFDA
Augustine Temperature Management, Llc
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model #...
Surgical Devices·817 affected·Mar 14, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
Surgical Devices·348 affected·Feb 25, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
Anterior Hip Pack - Surgical Kit
Surgical Devices·100 affected·Feb 25, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
Total Knee Pack - Surgical Kit
Surgical Devices·76 affected·Feb 25, 2022
High RiskFDA
Ansell Healthcare Products Llc
Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
Surgical Devices·74 affected·Feb 19, 2022
High RiskFDA
Dollar Tree Distribution, Inc.
Medical Device products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Ten...
Surgical Devices·0 affected·Feb 18, 2022
High RiskFDA
Nextremity Solutions
Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
Surgical Devices·89 affected·Feb 10, 2022
High RiskFDA
Nextremity Solutions
Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument
Surgical Devices·239 affected·Feb 10, 2022
High RiskFDA
Nextremity Solutions
Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument
Surgical Devices·285 affected·Feb 10, 2022
High RiskFDA
C.r. Bard Inc
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
Surgical Devices·2,120 affected·Jan 27, 2022
High RiskFDA
C.r. Bard Inc
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
Surgical Devices·1,620 affected·Jan 27, 2022
CriticalFDA
Teleflex Medical Inc
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Tre...
Surgical Devices·1,265 affected·Jan 11, 2022
CriticalFDA
Teleflex Medical Inc
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, P...
Surgical Devices·1,874 affected·Jan 11, 2022
CriticalFDA
Teleflex Medical Inc
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (P...
Surgical Devices·5,530 affected·Jan 11, 2022
CriticalFDA
Teleflex Medical Inc
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombo...
Surgical Devices·14,583 affected·Jan 11, 2022
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equip...
Surgical Devices·288,152,790 affected·Jan 6, 2022
High RiskFDA
Covidien Llc
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. P...
Surgical Devices·1,994 affected·Dec 17, 2021
High RiskFDA
Smith & Nephew, Inc.
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic...
Surgical Devices·271 affected·Dec 14, 2021