Category

Surgical Devices Recalls

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

3,817 recalls
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939
Surgical Devices·18 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643...
Surgical Devices·26,171 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION CATH,12FR W/H20 1...
Surgical Devices·1,012,700 affected·Nov 15, 2023
High RiskFDA
Encore Medical, Lp
DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR K...
Surgical Devices·37 affected·Nov 10, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduc...
Surgical Devices·2,551 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter int...
Surgical Devices·1 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0...
Surgical Devices·717 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter...
Surgical Devices·0 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter int...
Surgical Devices·3 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter...
Surgical Devices·1,784 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the b...
Surgical Devices·4 affected·Nov 7, 2023
High RiskFDA
Merit Medical Systems, Inc.
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC21...
Surgical Devices·717 affected·Nov 6, 2023
High RiskFDA
Merit Medical Systems, Inc.
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
Surgical Devices·59 affected·Nov 6, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile; (2) Medli...
Surgical Devices·620,735 affected·Oct 16, 2023
High RiskFDA
Becton Dickinson Infusion Therapy Systems Inc.
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Surgical Devices·528,000 affected·Oct 4, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Surgical Devices·2,460 affected·Sep 29, 2023
High RiskFDA
Musculoskeletal Transplant Foundation, Inc.
DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from tr...
Surgical Devices·18 affected·Sep 22, 2023
CriticalFDA
Asensus Surgical Inc
Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catal...
Surgical Devices·21 affected·Sep 15, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides com...
Surgical Devices·12 affected·Sep 12, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
Surgical Devices·237 affected·Sep 12, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-180-015
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-010
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-005
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Edwards Lifesciences, Llc
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Surgical Devices·185 affected·Sep 7, 2023
High RiskFDA
Encore Medical, Lp
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Surgical Devices·146 affected·Sep 6, 2023
High RiskFDA
Convergent Dental
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
Surgical Devices·39 affected·Sep 1, 2023
High RiskFDA
Becton Dickinson Infusion Therapy Systems Inc.
REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Surgical Devices·98,000 affected·Aug 29, 2023
High RiskFDA
Dkk Dai-ichi Shomei Co., Ltd.
LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Au...
Surgical Devices·1,211 affected·Aug 23, 2023
High RiskFDA
Dkk Dai-ichi Shomei Co., Ltd.
LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro s...
Surgical Devices·256 affected·Aug 23, 2023
High RiskFDA
Covidien Lp
Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
Surgical Devices·3,050 affected·Aug 22, 2023
High RiskFDA
Olympus Corporation Of The Americas
Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L...
Surgical Devices·60,102 affected·Aug 10, 2023
High RiskFDA
Arrow International Inc.
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Surgical Devices·190 affected·Aug 10, 2023
CriticalFDA
Arrow International Inc.
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TT...
Surgical Devices·172 affected·Aug 10, 2023
CriticalFDA
Arrow International Inc.
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therape...
Surgical Devices·180 affected·Aug 10, 2023
High RiskFDA
Encore Medical, Lp
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Surgical Devices·20 affected·Aug 4, 2023
High RiskFDA
Encore Medical, Lp
DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
Surgical Devices·10 affected·Aug 4, 2023
High RiskFDA
Encore Medical, Lp
DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 3...
Surgical Devices·64 affected·Aug 4, 2023
High RiskFDA
Ansell Healthcare Products Llc
NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
Surgical Devices·378 affected·Aug 3, 2023