Category
Surgical Devices Recalls
3,817 surgical devices recalls on record from CPSC, FDA, and USDA.
3,817 recalls
High RiskFDA
B Braun Medical Inc
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PE...
Surgical Devices2,760 affectedSep 18, 2025
High RiskFDA
Surgical Theater Inc
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Surgical Devices45 affectedSep 16, 2025
High RiskFDA
Surgical Theater Inc
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Surgical Devices3 affectedSep 16, 2025
High RiskFDA
Surgical Theater Inc
Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological sy...
Surgical Devices19 affectedSep 16, 2025
High RiskFDA
Surgical Theater Inc
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
Surgical Devices3 affectedSep 16, 2025
High RiskFDA
Surgical Theater Inc
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
Surgical Devices17 affectedSep 16, 2025
High RiskFDA
Surgical Theater Inc
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
Surgical Devices50 affectedSep 16, 2025
High RiskFDA
Iantrek Inc.
C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Gon...
Surgical Devices198 affectedSep 6, 2025
High RiskFDA
Iantrek Inc.
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodi...
Surgical Devices1,262 affectedSep 6, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Athere...
Surgical Devices616 affectedAug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Ather...
Surgical Devices199 affectedAug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Athere...
Surgical Devices141 affectedAug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Ather...
Surgical Devices561 affectedAug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser At...
Surgical Devices173 affectedAug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Athere...
Surgical Devices1,019 affectedAug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Lase...
Surgical Devices795 affectedAug 29, 2025
High RiskFDA
Corneat Vision, Ltd.
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
Surgical Devices630 affectedAug 18, 2025
High RiskFDA
Alcon Research Llc
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number...
Surgical Devices25,778 affectedAug 5, 2025
High RiskFDA
Alcon Research Llc
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number...
Surgical Devices330 affectedAug 5, 2025
High RiskFDA
Alcon Research Llc
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number...
Surgical Devices6 affectedAug 5, 2025
CriticalFDA
Medline Industries, Lp
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401...
Surgical Devices7,913 affectedJul 31, 2025
High RiskFDA
Olympus Corporation Of The Americas
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number:...
Surgical Devices155 affectedJul 25, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Produc...
Surgical Devices907 affectedJul 18, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description...
Surgical Devices927 affectedJul 18, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Descripti...
Surgical Devices447 affectedJul 18, 2025
High RiskFDA
C.r. Bard Inc
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Surgical Devices4,300 affectedJul 17, 2025
High RiskFDA
C.r. Bard Inc
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
Surgical Devices4,300 affectedJul 17, 2025
High RiskFDA
Medtronic Xomed, Inc.
IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping...
Surgical Devices214 affectedJul 17, 2025
High RiskFDA
Stryker Communications
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Surgical Devices40 affectedJul 15, 2025
CriticalFDA
Medline Industries, Lp - Northfield
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 40120...
Surgical Devices398 affectedJul 14, 2025
High RiskFDA
Carefree Surgical Specialties
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25...
Surgical Devices500 affectedJul 1, 2025
High RiskFDA
Carefree Surgical Specialties
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5p...
Surgical Devices65 affectedJul 1, 2025
High RiskFDA
Carefree Surgical Specialties
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25...
Surgical Devices500 affectedJul 1, 2025
High RiskFDA
Carefree Surgical Specialties
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Ro...
Surgical Devices20 affectedJul 1, 2025
High RiskFDA
Boston Scientific Corporation
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Surgical Devices445 affectedJun 25, 2025
High RiskFDA
Steris Corporation
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
Surgical Devices59 affectedJun 23, 2025
High RiskFDA
Steris Corporation
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
Surgical Devices167 affectedJun 23, 2025
High RiskFDA
Volcano Corp
Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with I...
Surgical Devices233,817 affectedJun 13, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATI...
Surgical Devices186 affectedMay 23, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
Surgical Devices36 affectedMay 23, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
Surgical Devices50 affectedMay 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
Surgical Devices50 affectedMay 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Surgical Devices50 affectedMay 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Surgical Devices50 affectedMay 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
Surgical Devices50 affectedMay 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Surgical Devices50 affectedMay 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
Surgical Devices50 affectedMay 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Surgical Devices50 affectedMay 21, 2025