Medical device recalls

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

201–225 of 390

HighFDA (Devices)·Z-2013-2026·2026-05-06
Medline Medical Procedure Kits with Neuro Sponges Recalled
Medline Industries is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may be out of specification. The kits were distributed worldwide.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PACK, Medline kit number/SKU DYNJ64479; 2. CRANIO/NEURO/SPINE, Medline kit number/SKU DYNJ901072D.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1943-2026·2026-05-06
Mesh Style Tip Protectors recalled lacking FDA clearance
Healthmark Industries Co., Inc. is recalling Mesh Style Tip Protectors (models CSW-03-2.0 and CSW-04-4.0) distributed nationwide because the product does not have FDA clearance.
Product
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2018-2026·2026-05-06
Medline medical procedure kits recalled for elevated endotoxin levels
Medline Industries is recalling 208 medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may exceed product specifications.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B; 2. RR-DR. CHHETRI MDL PACK, Medline Kit Number/SKU DYNJ62635B.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2017-2026·2026-05-06
Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin
Medline Industries is recalling multiple medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels. The affected kits were distributed worldwide.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNT, Medline Kit Number/SKU CDS840193V; 2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J; 3. VP SHUNT ADULT PACK-LF, Medline Kit Number/SKU DYNJ0117497G; 4. PICC LINE PACK
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1989-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Recall
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral RT Size 3 Cement components due to external sterile packaging that was adhered to internal sterile packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1826-2026·2026-05-06
WHILL Model C2 Powered Wheelchair Recalled for Bluetooth Security Vulnerability
WHILL Model C2 powered wheelchairs with software versions before HMI 2.22 and MC 1.13 are recalled due to a Bluetooth Low Energy (BLE) communication vulnerability identified by CISA. Approximately 4,685 units distributed in Kansas are affected.
Product
WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1992-2026·2026-05-06
Depuy Synthes ATTUNE Revision Hinge Femoral implants recalled for sterility risk
DePuy Synthes is recalling ATTUNE Revision Hinge Femoral knee implants because external sterile packaging was found adhered to internal packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2040-2026·2026-05-06
Medline Medical Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling specific blood culture and blood draw kits containing Webcol Large Alcohol Prep Pads that were found to be non-sterile due to bacterial contamination discovered during a sterilization audit.
Product
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520; 2. BLOOD DRAW KIT, Medline Kit SKU EBSI1317.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2012-2026·2026-05-06
Medline Neuro Sponges in Spine Procedure Kits Recalled for Out-of-Specification Endotoxin
Medline is recalling Spine Pack-LF medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels detected during an internal review. The affected kits were distributed worldwide.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2024-2026·2026-05-06
Medline Medical Procedure Kits Recalled for High Endotoxin Levels
Medline Industries is recalling medical procedure kits containing Neuro Sponges because of 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. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M; 2. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645B; 3. ENT PK 1008847, Medline Kit Number/SKU DYNJ42319C; 4. ENDO SINUS PACK, Medl
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2025-2026·2026-05-06
Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin
Medline is recalling 22,116 medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may be out-of-specification. The products are distributed worldwide.
Product
Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1948-2026·2026-05-06
Medtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs
Medtronic Sphere-9 Catheters used for cardiac ablation may trigger ventricular fibrillation during radiofrequency therapy in patients with Biotronik implantable defibrillators due to an interaction between catheter current flow and a device safety feature.
Product
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2022-2026·2026-05-06
Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin
Medline is recalling medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may exceed specifications. Approximately 21,288 kits have been distributed worldwide.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline Kit Number/SKU CDS983493N; 2. TLIF PACK, Medline Kit Number/SKU DYNJ02476O; 3. DONOR FREE FLAP PACK-LF, Medline Kit Number/SKU DYNJ0426069N; 4. DONOR FREE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2015-2026·2026-05-06
Medline medical procedure kits recalled for elevated endotoxin levels
Medline Industries is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels detected during an internal review. Affected kits include the Major Neuro Pack-LF, Angiography Pack, and Neuro SEO models.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEURO PACK-LF, Medline Kit Number/SKU DYNJ0578916X; 2. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ51637D; 3. NEURO SEO, Medline Kit Number/SKU DYNJ65650.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1995-2026·2026-05-06
Straumann n!ce Zr HT Dental Implant Abutments Recalled for Incorrect Screw Seat
Straumann USA LLC is recalling 6 units of Straumann n!ce Zr, HT endosseous dental implant abutments (Article 010.0158) due to an incorrect screw seat interface that could affect proper implant function.
Product
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2043-2026·2026-05-06
Medline IV Start and Securement Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling multiple IV start and securement kits nationwide because they contain non-sterile Webcol Large Alcohol Prep Pads due to discovery of a bacterial contaminant during sterilization testing.
Product
Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 2. IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700; 3. IV START KIT (Centurion), Medline Kit SKU IV
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2011-2026·2026-05-06
Medline medical procedure kits recalled for out-of-specification endotoxin levels
Medline Industries is recalling medical procedure kits containing Neuro Sponges for spinal fusion due to higher-than-expected endotoxin levels that may be out-of-specification.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2027-2026·2026-05-06
Medline Medical Procedure Kits Recalled for High Endotoxin Levels
Medline is recalling medical procedure kits containing neuro sponges due to higher-than-expected endotoxin levels that may be out-of-specification. The kits were distributed worldwide.
Product
Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2030-2026·2026-05-06
Medline Microdisectomy Kits Recalled for High Endotoxin Levels
Medline is recalling Microdisectomy Packs containing Neuro Sponges due to higher-than-expected endotoxin levels found during an internal review. The affected products may be out-of-specification for endotoxin.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585B; 2. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585C; 3, MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585D.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2023-2026·2026-05-06
Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin
Medline Industries is recalling three medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels identified during internal review. The affected kits may be out-of-specification for endotoxin.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J; 2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Number/SKU DYNJ66447; 3. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ90836
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1991-2026·2026-05-06
Depuy Synthes ATTUNE Revision Hinge Femoral Knee Component Recall
Depuy Synthes is recalling 3 units of the ATTUNE Revision Hinge Femoral (Right, Size 5, Cemented) knee implant due to external sterile packaging adhered to internal sterile packaging, potentially compromising product sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1999-2026·2026-05-06
Abbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
Abbott Point Of Care is recalling approximately 7.6% of specific i-STAT EG7+ cartridge lots due to a manufacturing issue causing falsely high pCO2 and low pH readings. Inaccurate results could lead clinicians to make unnecessary or harmful medical interventions.
Product
i-STAT EG7+ cartridge; List Number: 03P76-25;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1987-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
DePuy Synthes is recalling one lot of ATTUNE Revision Hinge Femoral components (left size 7, part number 150450107) due to external sterile packaging adhered to internal packaging, potentially compromising product sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2033-2026·2026-05-06
Medline medical procedure kits recalled for elevated endotoxin levels
Medline Industries is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels found on the products. Affected kits were distributed worldwide.
Product
Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2009-2026·2026-05-06
Medline Neuro Sponges in Pediatric Airway Kits recalled for endotoxin
Medline Industries is recalling Pediatric Airway Procedure Kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may be out of specification.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Number SKU DYNJ86657A
Category
Medical Device
Distribution
0 states

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