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.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

6176–6200 of 40007

HighFDA (Devices)·Z-2731-2024·2024-09-04
Stryker iBur 3.0mm surgical burr recalled over thermal hazard
Stryker Corporation is recalling the iBur 3.0mm Precision Match Head surgical burr because it may generate higher-than-specified temperatures during use, potentially causing thermal injury that may require medical intervention.
Product
Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngolo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2898-2024·2024-09-04
BVI CustomEyes Procedure Packs with Sol-M syringes recalled
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The recall affects 123 units distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001649;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2729-2024·2024-09-04
Stryker iBur surgical bur recalled for potential overheating at junction
Stryker has recalled 1171 units of iBur 5.0mm surgical burs due to potential overheating at the bur shank junction. The overheating could cause thermal injury requiring medical intervention.
Product
Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngol
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2735-2024·2024-09-04
Immunoassay analyzer software may delay test processing with automation systems
A software issue in DxI 9000 Access analyzers connected to laboratory automation systems may prevent processing of all samples, flagging tests as timed out and potentially delaying patient results.
Product
DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2798-2024·2024-09-04
BVI CustomEyes Procedure Packs Recalled for Defective Sol-M Syringes
Beaver Visitec International voluntarily recalled BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The recall affects 69 units distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000162;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2623-2024·2024-09-04
Medline procedure packs with syringes recalled due to leaks and breakage
Medline is recalling procedure packs containing Shenli syringes due to leaks, breakage, and quality issues that may pose risks to patient health. Over 1.6 million units have been distributed worldwide.
Product
Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) FTMC LOCAL PACK-LF, pack number DYNJ54607A, 3) LOCAL PACK, pack number DYNJ61839B
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2631-2024·2024-09-04
Medline procedure packs with syringes recalled due to leaks and breakage
Medline Industries recalled procedure packs containing Shenli syringes due to leaks, breakage, and quality defects. The recalled units were distributed worldwide and may pose a risk to patient health.
Product
Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2761-2024·2024-09-04
Medline Circumcision Kits Recalled Due to Plastic Syringe Quality Issues
Medline is recalling specific circumcision procedure kits because they contain plastic syringes with identified leaks, breakage, and other quality issues that may pose a risk to patient health.
Product
Medline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 2) CIRCUMCISION TRAY , Pack Number CIT6135BH; 3) CIRCUMCISION TRAY , Pack Number CIT2465; 4) CIRCUMCISION TRAY , Pack Number CIT4920; 5) CIRCUMCISION TRAY , Pack Number CIT7455; 6) CIRCUMCIS
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2762-2024·2024-09-04
Medline procedural kits recalled due to syringe quality issues
Medline is recalling specific procedural kits because they contain plastic syringes with leaks or breakage risks that may pose a threat to patient health.
Product
Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584; 2) SR C SECTION, Pack Number DYNJ908584A; 3) C SECTION, Pack Number DYNJ909098
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2753-2024·2024-09-04
Medline Umbilical Line Kits Recalled Due to Syringe Quality Issues
Medline is recalling Umbilical Line Kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and other quality issues.
Product
Medline procedural kits labeled as: UMBILICAL LINE KIT W/FOAM, Pack Number DYNDL1588A
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2730-2024·2024-09-04
Stryker iBur surgical bur may overheat during bone-cutting procedures
Stryker iBur 3.0mm Diamond Match Head surgical cutting tools may reach temperatures exceeding safe operating limits during bone surgery, potentially causing thermal tissue injury. About 2,507 units worldwide are affected.
Product
Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2777-2024·2024-09-04
Medline Centurion Procedure Packs Recalled Due to Syringe Quality Issues
Medline Industries is recalling Centurion procedure packs containing defective Caina syringes due to leaks and breakage risks.
Product
Centurion procedure packs, containing Caina syringes, labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6860A; 2) RETINAL INJECTION KIT, Pack Number MNS12465
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2769-2024·2024-09-04
Medline Centurion Procedure Kits Recalled for Syringe Leaks and Breakage
Medline Industries is recalling Centurion procedure kits with plastic syringes affected by an FDA Safety Alert. The syringes may leak, break, or develop quality issues that could pose risks to patient health.
Product
Centurion procedure kits labeled as: UMBILICAL VESSEL TRAY, Pack Number UVT1100
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2750-2024·2024-09-04
Medline Procedural Kits with Defective Plastic Syringes Recalled
Medline procedural kits contain plastic syringes affected by an FDA Safety Alert. The syringes may leak or break, posing risks to patients during medical procedures.
Product
Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number DYNJ902703K; 3) ENT TYMPANOPLASTY PACK-LF , Pack Number DYNJ38988J; 4)FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179A; 5) FREE FLAP TRAM ADD ON PACK, Pa
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2778-2024·2024-09-04
Medline Centurion Procedure Packs with Syringes Recalled for Defects
Medline has recalled Centurion procedure packs containing syringes due to leaks, breakage, and quality issues. These defects may pose a risk to patient health.
Product
Centurion procedure packs, containing Caina syringes, labeled as: SHAVE KIT, Pack Number MNS8250
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2746-2024·2024-09-04
Medline procedural kits recalled due to defective plastic syringes
Medline is recalling procedural kits with defective syringes due to leaks and breakage that may pose patient health risks. Affected products include biopsy packs, circumcision trays, and breast biopsy kits.
Product
Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A; 2) CIRCUMCISION TRAY, Pack Number CIT7210; 3) CIRCUMCISION TRAY, Pack Number DYNDA2271; 4) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 5) UCLA - BREAST BIOPSY KITDYNDH1512A
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2919-2024·2024-09-04
BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Quality Concern
Beaver Visitec International is recalling 227 units of BVI CustomEyes Procedure Packs containing syringes from Sol-Millennium Medical due to a quality concern affecting those syringes.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001838;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2775-2024·2024-09-04
Medical procedure packs containing defective syringes recalled by Medline
Medline is recalling Centurion procedure packs with plastic syringes that have leaks, breakage, and other quality issues. These defects may pose a risk to patient health.
Product
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAST BIOPSY KIT, Pack Name DYNDH1512A; 3) CIRCUMCISION TRAY, Pack Name CIT6720; 4) CIRCUMCISION TRAY, Pack Name CIT6715; 5) CIRCUMCISION TRAY, Pack Name CIT7
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2755-2024·2024-09-04
Medline Procedural Kits Recalled Due to Defective Plastic Syringes
Medline is recalling multiple procedural kits containing defective plastic syringes that may leak or break. The syringes were identified in an FDA Safety Alert issued on March 19, 2024.
Product
Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) PORT DRESSING CHANGE TRAY, Pack Number DT18415; 4) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2733-2024·2024-09-04
GE Healthcare Proteus XR/a X-Ray System Missing De-Installation Manual
GE Healthcare's Proteus XR/a stationary X-ray system lacks a required de-installation manual, creating risk of personnel injury during device removal.
Product
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2747-2024·2024-09-04
Medline Procedural Kits Recalled Due to Defective Plastic Syringes
Medline is recalling multiple procedural kits containing plastic syringes that may leak, break, or have quality defects. These defects may pose a risk to patient health during surgical procedures.
Product
Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016T; 3) MAJOR EAR PACK, Pack Number CMPJ01846O; 4) EAR PACK, Pack Number CMPJ05884J; 5) MZ EAR PACK , Pack Number CMPJ09860D; 6) KIT MAJOR EAR CHRG, Pack
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2727-2024·2024-09-04
Stryker iBur surgical burs recalled due to overheating risk
Stryker Corporation recalls iBur 3.0mm surgical burs used in neurosurgery, spinal, and ENT procedures due to potential overheating at the bur-shank interface. The heat risk may cause tissue damage requiring medical intervention.
Product
Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngolo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2773-2024·2024-09-04
Medical convenience kits with syringes recalled due to quality issues
Medline Industries is recalling Centurion procedure packs containing plastic syringes affected by an FDA Safety Alert from March 19, 2024. The syringes may have leaks, breakage, or other quality issues that could pose a health risk.
Product
Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2) CIRCUMCISION TRAY, Pack Number CIT6325; 3) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 4) LUMBAR PUNCTURE TRAY, Pack Number PT215; 5) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2776-2024·2024-09-04
Centurion Procedure Packs with Plastic Syringes Recalled for Leaks and Breakage
Medline Industries is recalling Centurion procedure packs containing plastic syringes due to leaks, breakage, and quality defects that may pose a risk to patient health. The affected products are distributed worldwide.
Product
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHROGRAM TRAY, Pack Number MNS11965A; 3) ARTHROGRAPH TRAY, Pack Number MNS12670A; 4) BREAST BIOPSY KIT, Pack Number DYNDH1512; 5) CIRCUMCISION KIT, Pack Numbe
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2614-2024·2024-09-04
Pediatric Tracheostomy Tubes Recalled Due to Defective Securement Flange
Smiths Medical recalls pediatric tracheostomy tubes from specific lots due to a manufacturing defect that may cause the securement flange to tear. No injuries have been reported.
Product
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRA
Category
Medical Device
Distribution
0 states

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6176–6200 of 40007