Category
Medical Devices Recalls
15,654 medical devices recalls on record from CPSC, FDA, and USDA.
15,654 recalls
High RiskFDA
American Contract Systems, Inc.
Vaginal Delivery, ASDV25B; Medical convenience kit
Medical Devices1 affectedAug 7, 2024
High RiskFDA
Howmedica Osteonics Corp.
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Medical Devices897 affectedAug 7, 2024
High RiskFDA
American Contract Systems, Inc.
IR Procedure Pack, CEAT19W; Medical convenience kit
Medical Devices1 affectedAug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Nasal Sinus Pack, MTSN26B; Medical convenience kit
Medical Devices57 affectedAug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Neuro Vascular, ANKV91A; Medical convenience kit
Medical Devices1 affectedAug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
Medical Devices18 affectedAug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Paracentesis Thoracente, SLPT76H; Medical convenience kit
Medical Devices504 affectedAug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Cath Lab Pack, CECL02P; Medical convenience kit
Medical Devices1 affectedAug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Endovascular AAA Pack, ESED52B; Medical convenience kit
Medical Devices93 affectedAug 7, 2024
High RiskFDA
Biofire Diagnostics, Llc
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
Medical Devices1,001 affectedAug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Shoulder, SESH18I; Medical convenience kit
Medical Devices60 affectedAug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Cysto, FTCY03L; Medical convenience kit
Medical Devices36 affectedAug 7, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
Medical Devices927 affectedAug 6, 2024
High RiskFDA
Abiomed, Inc.
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
Medical Devices8 affectedAug 5, 2024
High RiskFDA
Howmedica Osteonics Corp.
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Medical Devices1 affectedAug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
Medical Devices9 affectedAug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
Medical Devices788 affectedAug 5, 2024
High RiskFDA
Abiomed, Inc.
Pump 381 Pump Set (US); Product Code: 1000080;
Medical Devices11,236 affectedAug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
Medical Devices1,889 affectedAug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
Medical Devices705 affectedAug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella CP Smart Assist Set; Product Code: 1000402;
Medical Devices39 affectedAug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
Medical Devices286 affectedAug 5, 2024
High RiskFDA
Ge Healthcare
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
Medical Devices2,138 affectedAug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
Medical Devices11,576 affectedAug 5, 2024
High RiskFDA
Ultradent Products, Inc.
Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/...
Medical Devices2,450 affectedAug 2, 2024
High RiskFDA
Auris Health Inc
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
Medical Devices176 affectedAug 2, 2024
High RiskFDA
Ultradent Products, Inc.
Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Desc...
Medical Devices560 affectedAug 2, 2024
High RiskFDA
Becton Dickinson & Co.
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically signif...
Medical Devices4,295 affectedAug 1, 2024
High RiskFDA
Becton Dickinson & Co.
BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacter...
Medical Devices764 affectedAug 1, 2024
High RiskFDA
Outset Medical, Inc.
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in ...
Medical Devices2,422 affectedAug 1, 2024
CriticalFDA
Fresenius Kabi Usa, Llc
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous in...
Medical Devices180 affectedAug 1, 2024
High RiskFDA
Coopersurgical, Inc.
Stainless Steel Sims Uterine Sound, Part Number 64-601
Medical Devices657 affectedJul 31, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Medical Devices1,164 affectedJul 29, 2024
High RiskFDA
Agfa N.v.
DR 800. Digital Radiography X-ray System.
Medical Devices141 affectedJul 29, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
Medical Devices143 affectedJul 29, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001113;
Medical Devices880 affectedJul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001737;
Medical Devices98 affectedJul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001609;
Medical Devices82 affectedJul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002075;
Medical Devices56 affectedJul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001973;
Medical Devices14 affectedJul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584003;
Medical Devices659 affectedJul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001635;
Medical Devices444 affectedJul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001605;
Medical Devices80 affectedJul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001503;
Medical Devices66 affectedJul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001944;
Medical Devices332 affectedJul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001486;
Medical Devices1,338 affectedJul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001110;
Medical Devices6 affectedJul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001338;
Medical Devices64 affectedJul 26, 2024