Medical device recalls

FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.

176–200 of 390

ModerateFDA (Devices)·Z-2111-2026·2026-05-13
Medline Convenience Kits recalled due to sterilization calibration issues
Medline Industries has recalled 6,676 units of multiple Medline Convenience Kits used in gynecological and other surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance.
Product
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) D&C/HYSTEROSCOPY PACK, Mo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2072-2026·2026-05-13
DEX Ophthalmic Tissue Forceps Safety Corrective Action Recall
Katalyst Surgical is recalling DEX Ophthalmic Tissue Forceps, 25ga Model DVF4016-25-S due to a field safety corrective action for instructions for use (IFU). The recall affects 90 units distributed nationwide in the US and internationally.
Product
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2086-2026·2026-05-13
Uric Acid in vitro diagnostic test distributed without FDA clearance
DFI Co., Ltd. is recalling its Uric Acid in vitro diagnostic test (REF: 31H0P) because the devices were distributed without required FDA premarket clearance or approval.
Product
Uric Acid in vitro diagnostic test REF: 31H0P
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2073-2026·2026-05-13
DEX Ophthalmic Tissue Forceps 23ga Maculorhexis Forceps Recalled
Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps, Model DVF4019-23, due to a field safety corrective action for instructions for use in DEX Forceps and Scissors. The device is distributed worldwide.
Product
DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2130-2026·2026-05-13
Medline Surgical Packs recalled due to sterilization equipment calibration issues
Medline Industries is recalling certain surgical packs because calibration issues with sterilization and packaging equipment may have affected sterility assurance. All recalled units were exposed to validated sterilization cycles but the calibration problems could impact sterility integrity.
Product
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CS, Model Number: DYNJP8401
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2082-2026·2026-05-13
One Step 10A In Vitro Diagnostic Test Distributed Without FDA Clearance
DFI Co., Ltd. is recalling the One Step 10A in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval. The recall affects 6533 units distributed nationwide in Florida, Pennsylvania, and England.
Product
One Step 10A in vitro diagnostic test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2122-2026·2026-05-13
Medline Convenience Kits sterilization calibration issue recalled
Medline is recalling Convenience Kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2076-2026·2026-05-13
DEX Ophthalmic Tissue Forceps require instructions-for-use correction
Katalyst Surgical is correcting the instructions for use (IFU) for DEX Ophthalmic Tissue Forceps (Model DVF4019-27) and related scissors due to a field safety issue.
Product
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2031-2026·2026-05-06
Insulin Pump Batteries Recalled After Sudden-Shutdown Reports
OmniDose is recalling 23,000 lithium battery packs used in its X4 insulin pumps after reports of unexpected shutdown.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1996-2026·2026-05-06
iLet Bionic Pancreas Software Versions Recalled for Delayed CGM Readings
Beta Bionics is recalling iLet Bionic Pancreas units with software versions 1.4.2 and 1.4.3 due to a compatibility issue with Dexcom G7 sensors that can cause delayed glucose readings and loss of automatic insulin adjustments.
Product
iLet Bionic Pancreas, REF: BB1001
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1770-2026·2026-05-06
Boston Scientific Pacemakers Subject to Software Update Advisory
Boston Scientific is issuing a software update (Brady SMR6) for certain ACCOLADE and PROPONENT pacemakers and cardiac resynchronization therapy devices. The advisory population is expanding to include all dual-chamber extended life and CRT-P devices.
Product
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Number L101; 3. ESSENTIO SR SL MRI Pacemaker, Model Number L110; 4. ESSENTIO
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1827-2026·2026-05-06
WHILL Model F Powered Wheelchair Bluetooth Communication Vulnerability
WHILL, INC. is recalling WHILL Model F powered wheelchairs with software versions before HMI 2.23 and MC 1.05 due to a Bluetooth Low Energy (BLE) communication vulnerability identified through the CISA Vulnerability Disclosure Program.
Product
WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1984-2026·2026-05-06
Immy Myco DDR Trident Neutralization Buffer B Recalled for Potential Contamination
Immuno-Mycologics, Inc. is recalling Immy Myco DDR Trident Bulk Neutralization Buffer B (60 X 30 mL, Lot F5061154) because the product may contain contaminants. The buffer is used for clinical specimen processing for Mycobacterium spp. diagnosis.
Product
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1771-2026·2026-05-06
Boston Scientific Cardiac Pacemakers Require Software Update
Boston Scientific is expanding a software advisory for ACCOLADE family pacemakers and cardiac resynchronization therapy devices. Updated software (Brady SMR6) is now available to address identified issues.
Product
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI, Mod
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2021-2026·2026-05-06
Medline and Centurion Medical Procedure Kits Recalled for High Endotoxin Levels
Medline Industries is recalling Medline and Centurion medical procedure kits containing neuro sponges due to higher-than-expected endotoxin levels that may cause the products to be out-of-specification.
Product
Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1947-2026·2026-05-06
AIDBAG First Aid Kits with Recalled Blood Glucose Meters Recalled
North American Rescue LLC. is recalling AIDBAG first aid kits containing McKesson TRUE Metrix PRO blood glucose meters that display an E-5 error code incorrectly, potentially delaying appropriate patient treatment.
Product
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, includ
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-2016-2026·2026-05-06
Medline Medical Procedure Kits with Neuro Sponges Recalled
Medline is recalling multiple medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may render the product out-of-specification.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medline Kit Number/SKU CDS840402AI; 2. OPEN HEART CDS, Medline Kit Number/SKU CDS984890V; 3. RR-NEURO VASCULAR PACK-LF, Medline Kit Number/SKU DYNJ0394874L; 4.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2038-2026·2026-05-06
Medline Medical Procedure Kits Recalled for High Endotoxin Levels
Medline is recalling certain medical procedure kits containing neuro sponges because they may have higher-than-expected endotoxin levels, indicating out-of-specification product in the market.
Product
Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2044-2026·2026-05-06
Medline Centurion Medical Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling Centurion medical convenience kits containing Webcol Large Alcohol Prep Pads after Cardinal Health determined the pads are non-sterile due to bacterial contamination discovered during sterilization testing.
Product
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2034-2026·2026-05-06
Medline medical procedure kits with neuro sponges recalled for endotoxin
Medline Industries is recalling medical procedure kits containing neuro sponges after internal review identified higher-than-expected endotoxin levels. In-market product may be out-of-specification for endotoxin.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medline Kit Number/SKU DYNJ0751220P; 2. ENSEMBLE RACHIS-LF, Medline Kit Number/SKU DYNJ47568B; 3. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555B; 4. UROLOG
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2028-2026·2026-05-06
Centurion Surgical ENT Prep Kits with Medline Neuro Sponges Recalled
Medline Industries is recalling Centurion Surgical ENT Prep Kits (Medline Neuro Sponges) due to higher-than-expected endotoxin levels that may render the product out-of-specification. Approximately 3,000 kits have been distributed worldwide.
Product
Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11715
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2001-2026·2026-05-06
Abbott i-STAT Blood Gas Cartridges Reporting Inaccurate pH and PCO2 Results
Abbott Point Of Care Inc. is recalling approximately 7.6% of i-STAT G3+, i-STAT EG6+, and i-STAT EG7+ blood gas cartridges due to a manufacturing issue causing falsely high PCO2 and low pH readings, which may lead to unnecessary or harmful clinical interventions.
Product
i-STAT G3+ cartridge; List Number: 03P78-26;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2005-2026·2026-05-06
epoc BGEM BUN Test Card for epoc Blood Analysis System
Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Cards due to risk of inaccurate pH and carbon dioxide readings that could lead to inappropriate or missed treatment of acid-base disorders.
Product
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2026-2026·2026-05-06
Medline Medical Procedure Kits Recalled for Higher Endotoxin Levels
Medline Industries is recalling medical procedure kits containing neuro sponges worldwide because testing found higher-than-expected endotoxin levels, indicating products may be out-of-specification.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ0532910L; 2. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ39461J; 3. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060I; 4. PK-MAD,SPI
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2042-2026·2026-05-06
Medline Centurion Medical Convenience Kits Recalled for Non-Sterility
Medline Industries is recalling Centurion medical convenience kits containing Webcol Large Alcohol Prep Pads due to discovery of non-sterile product contaminated with Paenibacillus phoenicis bacteria during sterilization testing.
Product
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE TRAY, Medline Kit SKU 75670
Category
Medical Device
Distribution
Distributed nationwide

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