FDA Recalls

The latest food, drug and medical device recalls reported by the U.S. Food and Drug Administration, newest first. Data updated Oct 21, 2026.

87,918 recalls · page 29 of 30

Class IIDrugOngoing

Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.

SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ

Class IIDrugOngoing

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 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

Class IIDrugOngoing

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 only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

Class IIDeviceOngoing

One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.

Intersurgical Inc · East Syracuse, NY

Class IIDeviceOngoing

OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.

Boston Scientific Corporation · Marlborough, MA

Class IIDeviceOngoing

Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).

AVID Medical, Inc. · Toano, VA

Class IIDeviceOngoing

One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.

Intersurgical Inc · East Syracuse, NY

Class IIDeviceOngoing

American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.

Class IIDeviceOngoing

Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL

Siemens Healthcare Diagnostics, Inc. · East Walpole, MA

Class IIDeviceOngoing

Blanketrol II Model 222S; Thermal regulating system.

Gentherm Medical, LLC · Blue Ash, OH

Class IIDeviceOngoing

Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Description: The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the humeral stem. Additionally, the system includes supporting standard instrument trays and all required accessories (e.g., security screws, peripheral screws). The restor3d rTSA System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The Veritas standard glenoid baseplate is the only component within scope of this field action. The patient-specific baseplate is unaffected by this defect and therefore not in scope. Component: Reverse Total Shoulder

Class IIDeviceOngoing

Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL

Siemens Healthcare Diagnostics, Inc. · East Walpole, MA

Class IIDeviceOngoing

Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001

Paragonix Technologies Inc. · Braintree, MA

Class IIDeviceOngoing

TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798

Tobii Dynavox Llc · Pittsburgh, PA

Class IIDeviceOngoing

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 Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.0.3 (IN-23630) Product Description: The ARVIS system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. The ARVIS Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated. Example orthopedic surgical procedures include but are not limited to: " Total Knee Arthroplasty " Unicompartmental Knee Arthroplasty: Tibial Transverse Resection " Hip Arthroplasty The ARVIS" head mounted display is for displaying augmented reality visualization and information to the user intraoperatively. The augmented/virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information. Component: NA

Class IIDeviceOngoing

Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.

Foundation Medicine, Inc. · Cambridge, MA

Class IIDeviceOngoing

American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSLM53AC; 3) CRANIAL PACK - 205992, Model Item Number MHCP75AH; 4) IMRI CRANI PACK - 213871, Model Item Number ANCI17AO; 5) CRANI PACK - 205942, Model Item Number ANCP30AP; 6) A-P PACK - 205936, Model Item Number ANAP22AP; 7) POSTERIOR PACK - 205960, Model Item Number ANPP15AR; 8) ANTERIOR CERVICAL PACK - 205935, Model Item Number ANAN51AI; 9) LAMINECTOMY PACK - 205957, Model Item Number ANLM40AG.

Class IIDeviceOngoing

MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW

Medtronic MiniMed, Inc. · Northridge, CA

Class IIDeviceOngoing

Cardiac Workstation 5000. Product Number: 860439.

Philips North America Llc · Cambridge, MA

Class IIDeviceOngoing

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly

Siemens Healthcare Diagnostics Products Ltd. · Caernarfon

Class IIDeviceOngoing

Suture Cinch Long 1pk. Endoscopic tissue approximation device.

Boston Scientific Corporation · Marlborough, MA

Class IIIDeviceOngoing

Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant

Paragon 28, Inc. · Englewood, CO

Class IIDeviceOngoing

EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Endoscopic measuring system, including catheter components.

Class IDeviceOngoing

BMC/REACTHEALTH Luna G3 APAP REF LG 3600

BMC Medical Co., Ltd. · Beijing

Class IIDeviceOngoing

Cardiac Workstation 7000. Product Number: 860441.

Philips North America Llc · Cambridge, MA

Class IIDeviceOngoing

Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.

Class IIDeviceOngoing

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly

Siemens Healthcare Diagnostics Products Ltd. · Caernarfon

Class IIIDeviceOngoing

Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant

Paragon 28, Inc. · Englewood, CO

Class IDeviceOngoing

Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter

Boston Scientific Corporation · Maple Grove, MN

Class IIDeviceOngoing

Lago X

Spectral Instruments Inc · Tucson, AZ