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

6126–6150 of 39844

HighFDA (Devices)·Z-2765-2024·2024-09-04
Medline Procedural Kits Recalled for Defective Plastic Syringes
Medline Industries is recalling multiple procedural kits containing plastic syringes affected by an FDA Safety Alert. The syringes have quality issues including leaks and breakage that may pose a risk to patient health.
Product
Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ; 2) ANTERIOR HIP PACK , Pack Number DYNJ82317; 3) ARTHROGRAM, Pack Number DYNDH1446A ; 4) ARTHROGRAM TRAY, Pack Number DYNDH1648; 5) ARTHROGRAM TRAY, Pack Number PAIN1396 ; 6) AR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2757-2024·2024-09-04
Medline procedural kits recalled due to syringe quality issues
Medline is recalling specific procedural kits because they contain plastic syringes affected by an FDA Safety Alert regarding leaks, breakage, and other quality issues.
Product
Medline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C; 2) BABY ADMIT KIT W/ PAMPERS, Pack Number DYKB1011B; 3) BABY KIT, Pack Number DYKP1021; 4) BABY KIT MED CENTER, Pack Number DYKM2149; 5) BABY KIT MED CENTER, Pack Number DYKM2149A; 6) GIRAFFE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2723-2024·2024-09-04
Stryker iBur 4.0mm surgical bur recall: excessive heat risk during bone surgery
Stryker iBur 4.0mm precision surgical burs may overheat where the shank meets the distal bushing. Excessive heat could cause minor tissue damage or thermal injury requiring medical intervention.
Product
Stryker iBur 4.0mm Precision 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)/ Otorhinolaryngology; an
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2625-2024·2024-09-04
Medical Convenience Kits with Defective Plastic Syringes Recalled
Medline Industries recalls medical convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose risks to patient health. About 1.6 million units were distributed worldwide.
Product
See RES Description
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-2767-2024·2024-09-04
Medical procedure kits with defective plastic syringes recalled due to quality issues
Medline Industries is recalling Centurion procedure kits due to plastic syringes with defects including leaks and breakage. These defects may compromise patient safety during medical procedures.
Product
Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) ARTHROGRAPH TRAY, Pack Number MNS12670A; 5) BIOPSY SKIN/LACER
Category
Medical Device
Distribution
0 states
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-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-2627-2024·2024-09-04
Medline Procedure Packs With Syringes Recalled for Quality Defects
Medline Industries has recalled over 1.6 million procedure packs containing syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected packs were distributed worldwide.
Product
Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2629-2024·2024-09-04
Medline Procedure Packs with Defective Syringes Recalled Worldwide
Medline recalls approximately 1.7 million procedure packs containing defective Shenli syringes due to leaks and breakage that may pose patient risks. The syringes are affected by an FDA Safety Alert from March 2024.
Product
Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2748-2024·2024-09-04
Medline Fetal Surgery Kits Recalled Due to Defective Plastic Syringes
Medline Industries is recalling procedural kits containing plastic syringes that may leak or break. The syringes were identified in a March 2024 FDA Safety Alert and may pose a risk to patient health.
Product
Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS840214Q; 2) FETAL SURGERY CDS-LF, Pack Number CMPJ26754O
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2766-2024·2024-09-04
Centurion procedure kits recalled due to defective plastic syringes
Medline Industries is recalling Centurion procedure kits containing plastic syringes with leaks and breakage issues. The defective syringes may pose a risk to patient health during medical procedures.
Product
Centurion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A; 2) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 5) PERITONSILLAR ABSCESS TRAY, Pack Number MN
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2610-2024·2024-09-04
Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Flange Defect
Smiths Medical is recalling specific lots of Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2744-2024·2024-09-04
Medline Circumcision Kits Recalled Due to Defective Syringes
Medline is recalling two circumcision tray kit models due to plastic syringes with leaks, breakage, and quality defects that may harm patients. The kits have been distributed worldwide.
Product
Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2593-2024·2024-09-04
Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Flange Defect
Smiths Medical is recalling specific lots of Bivona tracheostomy tubes because the securement flange may tear due to a manufacturing defect.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2726-2024·2024-09-04
Stryker iBur Diamond Round surgical bur recalled for thermal overheating risk
Stryker iBur 4.0mm Diamond Round surgical burs may reach temperatures higher than specified, potentially causing thermal injury or tissue damage during bone-cutting procedures. Approximately 1,706 affected units have been distributed worldwide.
Product
Stryker iBur 4.0mm 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)/ Otorhinolaryngology; and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2780-2024·2024-09-04
Centurion Procedure Packs with Defective Syringes Recalled Worldwide
MEDLINE INDUSTRIES is recalling Centurion procedure packs containing syringes with documented leaks, breakage, and other quality defects. The affected syringes may pose a risk to patient health during medical procedures.
Product
Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A; 2) CIRCUMCISION KIT, Pack Number CIT6535; 3) CIRCUMCISION KIT, Pack Number CIT7095; 4) CIRCUMCISION TRAY, Pack Number CIT6860A; 5) CIRCUMCISION TRAY, Pack N
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2792-2024·2024-09-04
BVI CustomEyes Procedure Packs with Sol-M Syringes Subject to Voluntary Recall
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes distributed nationwide. The recall affects 35 units with Part Number 584770 and is classified as FDA Class II.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584770;
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-2768-2024·2024-09-04
Medline Centurion Procedure Kits Recalled for Syringe Leaks and Breakage
Medline Industries is recalling multiple Centurion procedure kit models due to plastic syringe defects including leaks and breakage that may pose a risk to patient safety. The affected kits were distributed worldwide.
Product
Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 2) 5FR 2L PICC LINE TRAY, Pack Number PICC0020; 3) 6" FEMORAL ARTERIAL LINE KIT, Pack Number ART245B; 4) ADVANCED REPAIR KIT, Pack Number SUT15940; 5) ARTHROGRAM TRAY, Pack Numbe
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-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-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

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6126–6150 of 39844