Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 123 of 548
FDA Devices Moderate Mar 15, 2023
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Datascope Corp.
FDA Devices Moderate Mar 15, 2023
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data use…
St. Jude Medical
FDA Devices Low Mar 15, 2023
PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
Preat Corp
FDA Devices Moderate Mar 15, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998…
Datascope Corp.
FDA Devices Moderate Mar 15, 2023
Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with …
HeartSine Technologies Ltd
FDA Devices Moderate Mar 15, 2023
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Datascope Corp.
FDA Devices Critical Mar 15, 2023
Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52…
Datascope Corp.
FDA Devices Moderate Mar 15, 2023
LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of b…
LetsGetChecked Inc.
FDA Devices Moderate Mar 15, 2023
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Elekta Inc
FDA Devices Moderate Mar 15, 2023
Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.
Linet Spol. S.r.o.
FDA Devices Moderate Mar 15, 2023
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data use…
St. Jude Medical
FDA Devices Moderate Mar 15, 2023
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Covidien, LP
FDA Devices Moderate Mar 15, 2023
CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data…
St. Jude Medical
FDA Devices Moderate Mar 15, 2023
Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
DiaSorin Molecular LLC
FDA Devices Moderate Mar 15, 2023
BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitam…
Aniara Diagnostica LLC
FDA Devices Moderate Mar 15, 2023
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Boston Scientific Corporation
FDA Devices Moderate Mar 15, 2023
CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PE…
Carefusion 2200 Inc
FDA Devices Moderate Mar 15, 2023
CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data …
St. Jude Medical
FDA Devices Moderate Mar 15, 2023
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, …
Siemens Healthcare Diagnostics Inc
FDA Devices Moderate Mar 15, 2023
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
Baxter Healthcare Corporation
FDA Devices Moderate Mar 15, 2023
CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data …
St. Jude Medical
FDA Devices Moderate Mar 15, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35…
Datascope Corp.
FDA Devices Moderate Mar 8, 2023
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
CooperVision, Inc.
FDA Devices Moderate Mar 8, 2023
Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGI…
Covidien, LP
FDA Devices Moderate Mar 8, 2023
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
CareFusion 303, Inc.
FDA Devices Moderate Mar 8, 2023
Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALO…
Covidien, LP
FDA Devices Moderate Mar 8, 2023
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
Wright Medical Technology, Inc.
FDA Devices Moderate Mar 8, 2023
Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
Covidien, LP
FDA Devices Moderate Mar 8, 2023
BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of th…
Maquet Medical Systems USA
FDA Devices Critical Mar 8, 2023
Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
Baxter Healthcare Corporation
FDA Devices Moderate Mar 8, 2023
Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Stryker Corporation
FDA Devices Moderate Mar 8, 2023
Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863…
Covidien, LP
FDA Devices Moderate Mar 8, 2023
MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
Unetixs Vascular, Inc.
FDA Devices Moderate Mar 8, 2023
Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA
Covidien, LP
FDA Devices Moderate Mar 8, 2023
Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
SEDECAL SA
FDA Devices Moderate Mar 8, 2023
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Summit Medical, LLC
FDA Devices Moderate Mar 8, 2023
DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physi…
Carestream Health, Inc.
FDA Devices Moderate Mar 8, 2023
Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissue…
Covidien, LP
FDA Devices Moderate Mar 8, 2023
MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
Unetixs Vascular, Inc.
FDA Devices Moderate Mar 8, 2023
SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing …
Coltene Whaledent Inc
FDA Devices Moderate Mar 8, 2023
Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 …
Covidien, LP
FDA Devices Moderate Mar 8, 2023
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood …
Stryker Corporation
FDA Devices Moderate Mar 8, 2023
Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 …
Covidien, LP
FDA Devices Moderate Mar 8, 2023
Ultracell Wick with 80cc Collection Bag, 20/box
Beaver Visitec International, Inc.
FDA Devices Moderate Mar 8, 2023
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture …
Biomerieux Inc
FDA Devices Moderate Mar 8, 2023
Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II …
Covidien, LP
FDA Devices Moderate Mar 8, 2023
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
CooperVision, Inc.
CPSC Moderate Mar 2, 2023
Smocked Runway Recalls Classic Whimsy Children's Pajamas Due to Violation of Federal Flammability Standards and Burn Hazard (Recall Alert)
FDA Devices Moderate Mar 1, 2023
Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Mar 1, 2023
HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous the…
Access Vascular, Inc