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

6151–6175 of 39844

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-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-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-2779-2024·2024-09-04
Centurion Procedure Packs With Defective Syringes Recalled Worldwide
Medline Industries is recalling Centurion procedure packs containing plastic syringes with identified leaks, breakage, and quality defects. The recall affects units distributed worldwide.
Product
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) CIRCUMCISION TRAY, Pack Number CIT6720; 3) CIRCUMCISION TRAY, Pack Number CIT6720A
Category
Medical Device
Distribution
0 states
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-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-2628-2024·2024-09-04
Medical Convenience Kits with Plastic Syringes Recalled Due to Quality Defects
Medline Industries is recalling medical convenience kits containing plastic syringes due to quality issues including leaks and breakage that may pose a risk to patient health. The recall affects 1,679,067 units distributed worldwide.
Product
See RES description
Category
Medical Device
Distribution
0 states
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-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-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-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-2630-2024·2024-09-04
Medline dialysis procedure packs recalled for syringe leaks and breakage
Medline procedure packs containing Shenli syringes are being recalled due to leaks, breakage, and quality issues that may pose risks to patient health. The recall involves 1,679,067 units distributed worldwide.
Product
Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack Number DYNJ36932A ; 3) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 4) DIALYSIS ACCESS PACK, Pack Number DYNJ91
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-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-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-2732-2024·2024-09-04
Custom Orthopedic Surgical Implant Does Not Match Design Specifications
A custom-made orthopedic surgical implant was supplied for a surgical procedure that did not match the design specifications. This mismatch could affect the proper fit and function of the device during surgery.
Product
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2741-2024·2024-09-04
Medline preop nerve block trays recalled for syringe quality defects
Medline is recalling Preop Nerve Block Tray kits worldwide due to plastic syringes with leaks, breakage, and quality defects. These defects were identified in an FDA safety alert and may pose risks to patient health.
Product
Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040H
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2819-2024·2024-09-04
Beaver Visitec Recalls Medical Device Syringes in CustomEyes Procedure Packs
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs because they contain defective syringes manufactured by Sol-M. The 237 affected units were distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000711;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2939-2024·2024-09-04
Beaver Visitec CustomEyes Procedure Packs with Sol-M Syringes Recalled
Beaver Visitec International is recalling CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes due to a voluntary recall by the syringe manufacturer, Sol-Millennium Medical, Inc.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002080;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2881-2024·2024-09-04
BVI CustomEyes Procedure Packs with Sol-M Syringes Subject to Voluntary Recall
Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. The affected units were distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001527;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2860-2024·2024-09-04
Syringes in BVI CustomEyes Procedure Packs Recalled Nationwide
Beaver Visitec International recalls BVI CustomEyes Procedure Packs containing Sol-M syringes distributed nationwide. The specific reason for the recall is not detailed in the FDA notice.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001338;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2934-2024·2024-09-04
BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes due to a voluntary recall initiated by the syringe manufacturer. 76 units affected nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002042;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2789-2024·2024-09-04
BVI CustomEyes Procedure Packs containing syringes recalled nationwide
BVI CustomEyes Procedure Packs containing Sol-M syringes are subject to a voluntary recall affecting 73 units distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584712;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2916-2024·2024-09-04
BVI CustomEyes Procedure Packs with Sol-M Syringes Subject to Voluntary Recall
Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The affected syringes are low dead space and luer slip tip models distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001818;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2927-2024·2024-09-04
BVI CustomEyes Procedure Packs with Sol-M Syringes Subject to Voluntary Recall
BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes are subject to a voluntary recall distributed nationwide. The recalled packs contain low dead space luer lock and luer slip 1ml syringes.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001943;
Category
Medical Device
Distribution
Distributed nationwide

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6151–6175 of 39844