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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 Devices·2,760 affected·Sep 18, 2025
High RiskFDA
Surgical Theater Inc
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Surgical Devices·45 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Surgical Devices·3 affected·Sep 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 Devices·19 affected·Sep 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 Devices·3 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
Surgical Devices·17 affected·Sep 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 Devices·50 affected·Sep 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 Devices·198 affected·Sep 6, 2025
High RiskFDA
Iantrek Inc.
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodi...
Surgical Devices·1,262 affected·Sep 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 Devices·616 affected·Aug 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 Devices·199 affected·Aug 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 Devices·141 affected·Aug 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 Devices·561 affected·Aug 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 Devices·173 affected·Aug 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 Devices·1,019 affected·Aug 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 Devices·795 affected·Aug 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 Devices·630 affected·Aug 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 Devices·25,778 affected·Aug 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 Devices·330 affected·Aug 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 Devices·6 affected·Aug 5, 2025
CriticalFDA
Medline Industries, Lp
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401...
Surgical Devices·7,913 affected·Jul 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 Devices·155 affected·Jul 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 Devices·907 affected·Jul 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 Devices·927 affected·Jul 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 Devices·447 affected·Jul 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 Devices·4,300 affected·Jul 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 Devices·4,300 affected·Jul 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 Devices·214 affected·Jul 17, 2025
High RiskFDA
Stryker Communications
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Surgical Devices·40 affected·Jul 15, 2025
CriticalFDA
Medline Industries, Lp - Northfield
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 40120...
Surgical Devices·398 affected·Jul 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 Devices·500 affected·Jul 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 Devices·65 affected·Jul 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 Devices·500 affected·Jul 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 Devices·20 affected·Jul 1, 2025
High RiskFDA
Boston Scientific Corporation
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Surgical Devices·445 affected·Jun 25, 2025
High RiskFDA
Steris Corporation
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
Surgical Devices·59 affected·Jun 23, 2025
High RiskFDA
Steris Corporation
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
Surgical Devices·167 affected·Jun 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 Devices·233,817 affected·Jun 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 Devices·186 affected·May 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 Devices·36 affected·May 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 Devices·50 affected·May 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 Devices·50 affected·May 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 Devices·50 affected·May 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 Devices·50 affected·May 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 Devices·50 affected·May 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 Devices·50 affected·May 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 Devices·50 affected·May 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 Devices·50 affected·May 21, 2025