Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

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151–175 of 247

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-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-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
HighFDA (Devices)·Z-2020-2026·2026-05-06
Medline Medical Procedure Kits With Neuro Sponges Recalled
Medline Industries is recalling medical 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: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G; 2. EPISTAXIS TRAY, Medline Kit Number/SKU DYNDA3240; 3. RHINO PACK, Medline Kit Number/SKU DYNJ46504B; 4. MSC SEPTO RHINO PA
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1960-2026·2026-05-06
Philips Ingenia Ambition S MRI Systems Recalled for Stiffness Value Errors
Philips is recalling certain Ingenia Ambition S MRI systems with MR Elastography software due to potential stiffness value errors that may occur when specific image reconstruction parameters are used in combination with Resoundant's algorithm.
Product
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2006-2026·2026-05-06
Leksell Vantage Arc System locking mechanism may not secure properly
Elekta, Inc. is recalling the Leksell Vantage Arc System because locking mechanisms may fail to properly secure to the Arc system, which could cause coordinate shifting during medical procedures.
Product
Brand Name: Leksell Vantage Arc System REF: 1053958
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-2032-2026·2026-05-06
Medline Neuro Sponges recalled for higher-than-expected endotoxin levels
Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may exceed specifications.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC38133
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2045-2026·2026-05-06
Medline medical convenience kits recalled for non-sterile alcohol prep pads
Medline Industries is recalling multiple medical convenience kits nationwide due to Webcol Large Alcohol Prep Pads that were found to be non-sterile. A contaminant (Paenibacillus phoenicis) was discovered during a routine sterilization dose audit.
Product
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVELINE KIT (Centurion), Medline Kit SKU DT17360 (Centurion); 2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A; 3. CVC DRESSING C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1994-2026·2026-05-06
Straumann n!ce PMMA Dental Implant Abutments Recalled for Screw Seat Defect
Straumann USA LLC is recalling Straumann n!ce PMMA Full-arch Restoration screw-retained bridge abutments (Article 010.0304) due to an incorrect screw seat interface. Five units were distributed to dental offices in eight states.
Product
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2036-2026·2026-05-06
Medline medical procedure kits with neuro sponges recalled for endotoxin
Medline Industries is recalling approximately 7004 medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that indicate out-of-specification product.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642-LF, Medline Kit Number/SKU DYNJ47491F; 3. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58274;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1951-2026·2026-05-06
Philips Achieva 1.5T MRI Scanner Stiffness Calculation Error Recall
Philips is recalling Achieva 1.5T MRI systems with MR Elastography software due to potential stiffness value errors that may occur with specific image reconstruction parameters, causing incorrect voxel size display in the default scan protocol.
Product
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2039-2026·2026-05-06
Medline Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling specific lots of medical convenience kits containing Webcol Large Alcohol Prep Pads because the pads were found to be non-sterile due to contamination with Paenibacillus phoenicis bacteria discovered during a sterilization audit.
Product
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line Insertion Kit, Medline Kit SKU ART155A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1954-2026·2026-05-06
Philips Evolution Upgrade 1.5T MRI Stiffness Calculation Error
Philips North America is recalling Philips Evolution Upgrade 1.5T MRI systems with MR Elastography due to potential stiffness value errors that may result in incorrect voxel size settings in the default scan protocol.
Product
Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2010-2026·2026-05-06
Medline Neuro Sponges in Medical Procedure Kits Recalled for High Endotoxin
Medline Industries is recalling Medline medical procedure kits containing Neuro Sponges (EH BRONCHOSCOPY, Kit Number DYNJT3270) 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: EH BRONCHOSCOPY, Medline Kit Number/SKU DYNJT3270
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2019-2026·2026-05-06
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 found during an internal review, indicating in-market product may be out-of-specification.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920F; 3. MEM MAXILLOFACIAL PACK-LF, Medline Kit Number/SKU DYNJ0660040S; 4. O
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2000-2026·2026-05-06
i-STAT Blood Gas Analyzer Cartridges Recalled for Inaccurate Results
Abbott is recalling certain i-STAT EG6+, EG7+, and G3+ blood gas cartridges that may report falsely high CO2 and falsely low pH results due to a manufacturing issue, potentially leading to unnecessary or harmful clinical interventions.
Product
i-STAT EG6+ cartridge; List Number: 03P77-25;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2035-2026·2026-05-06
Medline robotic hysterectomy procedure kits recalled for elevated endotoxin
Medline Industries is recalling robotic hysterectomy procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may indicate out-of-specification product in distribution worldwide.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B; 2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269C; 3. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269D.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1990-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
DePuy Synthes is recalling 3 units of the ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM due to external sterile packaging found adhered to internal packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2041-2026·2026-05-06
Medline and Centurion Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling specific lots of medical convenience kits containing non-sterile Webcol Large Alcohol Prep Pads due to discovery of Paenibacillus phoenicis contamination. Affected kits were distributed nationwide.
Product
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE KIT, Medline Kit SKU UROT1044; 2. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770; 3. IV START KIT, Medline Kit SKU DYNDV2520; 4. ARTERIAL LINE
Category
Medical Device
Distribution
Distributed nationwide

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151–175 of 247