Recalls & alerts
435 alerts recorded, refreshed every six hours. Filter by source or category.
- Moderate risk
Maquet Critical Care AB : GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care…
- Moderate risk
Arrowhead DE LLC : Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516,…
- Moderate risk
Tobii Dynavox Llc : TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
- Moderate risk
Beckman Coulter Inc. : Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU…
- Moderate risk
Gentherm Medical, LLC : Innercool Coolblue Console, Model STx; Thermal regulating system.
- Moderate risk
Fort Defiance Industries, LLC : Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
- High risk
Boston Scientific Corporation : Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
- Moderate risk
Beckman Coulter Inc. : Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520;…
- High risk
Bard Access Systems, Inc. : BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver…
- High risk
Boston Scientific Corporation : Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
- Low risk
Paragon 28, Inc. : Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
- Moderate risk
Siemens Healthcare Diagnostics Products Ltd. : Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
- Moderate risk
ConvaTec, Inc : Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716,…
- Moderate risk
Covidien, LLC : EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL…
- Low risk
Paragon 28, Inc. : Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
- Moderate risk
Boston Scientific Corporation : Suture Cinch Long 1pk. Endoscopic tissue approximation device.
- Moderate risk
Siemens Healthcare Diagnostics Products Ltd. : Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
- Moderate risk
Medtronic MiniMed, Inc. : MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
- Moderate risk
American Contract Systems Inc : American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number…
- Moderate risk
Foundation Medicine, Inc. : Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
- Moderate risk
Kico Knee Innovation Company : Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap…
- Moderate risk
Tobii Dynavox Llc : TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
- Moderate risk
Paragonix Technologies Inc. : Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
- Moderate risk
Siemens Healthcare Diagnostics, Inc. : Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
- Moderate risk
restor3d Inc. : Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software…
- Moderate risk
Siemens Healthcare Diagnostics, Inc. : Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
- Moderate risk
American Contract Systems Inc : American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013,…
- Moderate risk
Intersurgical Inc : One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
- Moderate risk
AVID Medical, Inc. : Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
- Moderate risk
Boston Scientific Corporation : OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
- Moderate risk
Intersurgical Inc : One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
- Moderate risk
American Regent, Inc. : Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx…
- Moderate risk
American Regent, Inc. : Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC…
- Moderate risk
SUN PHARMACEUTICAL INDUSTRIES INC : Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed…
- High risk
Fresenius Kabi USA, LLC : Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake…
- Moderate risk
American Regent, Inc. : Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose…
Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.