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15,654 recalls
High RiskFDA
American Contract Systems, Inc.
Vaginal Delivery, ASDV25B; Medical convenience kit
Medical Devices·1 affected·Aug 7, 2024
High RiskFDA
Howmedica Osteonics Corp.
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Medical Devices·897 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
IR Procedure Pack, CEAT19W; Medical convenience kit
Medical Devices·1 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Nasal Sinus Pack, MTSN26B; Medical convenience kit
Medical Devices·57 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Neuro Vascular, ANKV91A; Medical convenience kit
Medical Devices·1 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
Medical Devices·18 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Paracentesis Thoracente, SLPT76H; Medical convenience kit
Medical Devices·504 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Cath Lab Pack, CECL02P; Medical convenience kit
Medical Devices·1 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Endovascular AAA Pack, ESED52B; Medical convenience kit
Medical Devices·93 affected·Aug 7, 2024
High RiskFDA
Biofire Diagnostics, Llc
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
Medical Devices·1,001 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Shoulder, SESH18I; Medical convenience kit
Medical Devices·60 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Cysto, FTCY03L; Medical convenience kit
Medical Devices·36 affected·Aug 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 Devices·927 affected·Aug 6, 2024
High RiskFDA
Abiomed, Inc.
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
Medical Devices·8 affected·Aug 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 Devices·1 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
Medical Devices·9 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
Medical Devices·788 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Pump 381 Pump Set (US); Product Code: 1000080;
Medical Devices·11,236 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
Medical Devices·1,889 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
Medical Devices·705 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella CP Smart Assist Set; Product Code: 1000402;
Medical Devices·39 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
Medical Devices·286 affected·Aug 5, 2024
High RiskFDA
Ge Healthcare
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
Medical Devices·2,138 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
Medical Devices·11,576 affected·Aug 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 Devices·2,450 affected·Aug 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 Devices·176 affected·Aug 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 Devices·560 affected·Aug 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 Devices·4,295 affected·Aug 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 Devices·764 affected·Aug 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 Devices·2,422 affected·Aug 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 Devices·180 affected·Aug 1, 2024
High RiskFDA
Coopersurgical, Inc.
Stainless Steel Sims Uterine Sound, Part Number 64-601
Medical Devices·657 affected·Jul 31, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Medical Devices·1,164 affected·Jul 29, 2024
High RiskFDA
Agfa N.v.
DR 800. Digital Radiography X-ray System.
Medical Devices·141 affected·Jul 29, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
Medical Devices·143 affected·Jul 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 Devices·880 affected·Jul 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 Devices·98 affected·Jul 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 Devices·82 affected·Jul 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 Devices·56 affected·Jul 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 Devices·14 affected·Jul 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 Devices·659 affected·Jul 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 Devices·444 affected·Jul 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 Devices·80 affected·Jul 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 Devices·66 affected·Jul 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 Devices·332 affected·Jul 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 Devices·1,338 affected·Jul 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 Devices·6 affected·Jul 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 Devices·64 affected·Jul 26, 2024