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

10976–11000 of 27647

HighFDA (Devices)·Z-2722-2024·2024-09-04
Stryker iBur Surgical Bur Recalled Due to Excessive Temperature Risk
Stryker recalls iBur 3.0mm Precision Round surgical burs due to potential for excessive temperatures where the bur shank meets the bushing. Thermal injury risk may require medical intervention.
Product
Stryker iBur 3.0mm 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-2734-2024·2024-09-04
Electrocardiograph Recall: CARDIOVIT AT-180 May Produce Signal Artifacts
Schiller is recalling CARDIOVIT AT-180 electrocardiographs due to potential high-frequency signal artifacts during ECG acquisition that may affect diagnostic accuracy. 1,084 units are affected worldwide.
Product
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
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-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-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
HighFDA (Devices)·Z-2632-2024·2024-09-04
Medline procedure packs with Shenli syringes recalled for leaks and breakage
Medline is recalling medical procedure packs containing Shenli syringes due to identified leaks, breakage, and quality issues. These kits may pose a risk to patient health during surgical procedures.
Product
Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number DYNDA1431A; 2) CVC INSERT BUNDLE 16CM, Part Number ECVC3260; 3) CENTRAL LINE INSERTION KIT, Part Number ECVC7440; 4) CENTRAL LINE INSERTION KIT, Part Number ECVC7445;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2771-2024·2024-09-04
Breast biopsy kits recalled due to defective syringes with leaks and breakage
Medline Industries recalls Centurion breast biopsy procedure kits due to defective plastic syringes that may leak or break. The syringes are affected by an FDA safety alert and pose potential risks during medical procedures.
Product
Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack number BT515A
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-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-2728-2024·2024-09-04
Stryker iBur Surgical Bur Recall Due to Excessive Heat Risk
Stryker is recalling iBur 4.0mm Coarse Diamond surgical burs that may overheat during use. Excessive heat could cause tissue or bone damage requiring medical intervention.
Product
Stryker iBur 4.0mm 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-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-2742-2024·2024-09-04
Medline Procedural Kits with Defective Syringes Recalled Worldwide
Medline procedural kits containing defective plastic syringes have been recalled worldwide due to potential leaks and breakage. The affected products include ultrasound catheter insertion and circumcision kits distributed globally.
Product
Medline procedural kits labeled as: 1) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 2) CIRCUMCISION TRAY, Pack Number CIT6715; 3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095
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-2745-2024·2024-09-04
Medline recalls three medical procedure kits with defective plastic syringes
Medline is recalling three procedural kits containing plastic syringes with leaks and breakage issues that may pose a risk to patient health. The kits have been distributed worldwide.
Product
Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516; 2) PICC INSERTION TRAY W/O CATH, Pack Number PICCNC0004; 3) VASCATH INSERTION PACK, Pack Number, CVI4825
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1748-2024·2024-09-04
La Superior Bakery Pan Guatemalteco Recalled for Undeclared Sesame
La Superior Bakery is recalling Pan Guatemalteco pastries due to undeclared sesame seeds. Consumers with sesame allergies face risk of allergic reaction.
Product
La Superior Bakery - Pan Guatemalteco packaged in clear plastic bag - 5 pastries per bag
Category
Food
Distribution
0 states
HighFDA (Drugs)·D-0644-2024·2024-09-04
Prescription Ibuprofen Recalled Due to Failed Impurity Specifications
Dr. Reddy's Laboratories is recalling IBU (Ibuprofen) 800 mg prescription tablets nationwide due to failed quality specifications. Testing found unknown impurities exceeding acceptable limits.
Product
IBU — IBU (IBUPROFEN)
Category
Drug
Distribution
Distributed nationwide
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-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-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-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-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-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-2839-2024·2024-09-04
BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Recall
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain Sol-Millennium Medical syringes that are subject to a manufacturer recall. A total of 103 units were distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001025;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2725-2024·2024-09-04
Stryker surgical bur may overheat and cause thermal tissue damage
Stryker iBur surgical burs may overheat during use in neurosurgery and spine surgery, potentially causing thermal tissue damage requiring medical intervention. Approximately 2,507 units were distributed worldwide.
Product
Stryker iBur 3.0mm 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-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

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10976–11000 of 27647