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

6101–6125 of 39844

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-2756-2024·2024-09-04
Medline Procedural Kits Recalled Due to Defective Plastic Syringes
Medline Industries is recalling multiple procedural kits containing defective plastic syringes that may leak or break. The affected kits were distributed worldwide.
Product
Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 4) RETINAL INJECTION KIT, Pack Number MNS12465; 5) UCLA - BREAST BIOPSY KIT, Pa
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2770-2024·2024-09-04
Medical procedure kits recalled due to defective plastic syringes
Medline's Centurion procedure kits are being recalled due to plastic syringes with leaks and breakage. The defective syringes may pose a risk to patient health during medical procedures.
Product
Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Number SPEC0262; 3) FINE LACERATION KIT, Pack Number SUT17215; 4) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 5) LACERATION TRAY, Pack Number DYNDL1
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-2624-2024·2024-09-04
Medical Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage
Medline Industries is recalling over 1.6 million medical convenience kits containing plastic syringes that may leak or break, posing a potential risk to patient safety. The affected kits are distributed worldwide.
Product
see RES for description
Category
Medical Device
Distribution
0 states
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-2736-2024·2024-09-04
Lab analyzer incorrectly configured for complex testing at waived facilities
Five Afinion 2 lab analyzers were distributed with incorrect configuration, potentially allowing waived laboratories to perform moderately complex assays that could produce erroneous results.
Product
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2797-2024·2024-09-04
BVI CustomEyes Procedure Packs Recalled for Sol-M Syringe Components
Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The recall affects 351 units distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000126;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2774-2024·2024-09-04
Centurion medical syringes recalled for leaks and breakage
Medline recalls Centurion procedure packs containing Caina syringes due to leaks, breakage, and quality issues that may pose risks to patient health in surgical procedures.
Product
Centurion procedure packs, containing Caina syringes, labeled as: 1) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 2) RETINAL INJECTION KIT, Pack Number MNS12465
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2838-2024·2024-09-04
BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled
Beaver Visitec International recalls BVI CustomEyes Procedure Packs containing Sol-M brand syringes due to manufacturer's voluntary recall. 130 units distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001020;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2751-2024·2024-09-04
Medline Procedural and Medical Kits Recalled for Defective Syringes
Medline is recalling procedural kits worldwide containing plastic syringes with identified leaks and breakage. The defective syringes were identified in an FDA Safety Alert from March 19, 2024, and may pose risks to patients.
Product
Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ; 2) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417A; 3) DRAWER 9L , Pack Number ACC010427A; 4) MEDICATION DELIVERY MODULE, Pack Number ACC010605 ; 5) DRAWER 3, Pack Number
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-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-2829-2024·2024-09-04
Voluntary Recall of BVI CustomEyes Procedure Packs With Sol-M Syringes
BVI CustomEyes Procedure Packs containing Sol-M manufactured low dead space and Luer Slip syringes are subject to a voluntary recall. Approximately 142 units were distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000866;
Category
Medical Device
Distribution
Distributed nationwide
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-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-2886-2024·2024-09-04
BVI CustomEyes Procedure Packs containing Sol-M Syringes Recalled Nationwide
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M-manufactured syringes. The recall affects 138 units distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001579;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2718-2024·2024-09-04
Nanoplasty 3D Bunion Implant System Recalled for Mechanical Failure Risk
Treace Medical Concepts is recalling its Nanoplasty 3D Bunion Implant (Model SK57) nationwide due to potential mechanical failures where locking screws may strip or fail to seat properly. No injuries have been reported.
Product
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2759-2024·2024-09-04
Medline Procedural Kits Recalled for Syringe Quality Defects
Medline is recalling NEURO TRAY procedural kits (Pack DYNJ55909B, Lot 23IBB122) due to plastic syringe defects including leaks and breakage that may pose a risk to patient health.
Product
Medline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909B
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-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-2864-2024·2024-09-04
BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. The voluntary recall affects approximately 1,629 units distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001376;
Category
Medical Device
Distribution
Distributed nationwide
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-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-2626-2024·2024-09-04
Medline Medical Convenience Kits with Syringes Recalled for Leaks and Breakage
Medline Industries recalls 1,679,067 medical convenience kits containing plastic syringes that may leak or break, posing potential risks to patient health.
Product
See RES description
Category
Medical Device
Distribution
0 states

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6101–6125 of 39844