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

4626–4650 of 13543

HighFDA (Devices)·Z-0336-2025·2024-11-20
IV Fluid Bags Found to Leak During Filling; Manufacturer Recalls Affected Units
The Metrix Company is recalling 2549 cases of SECURE 100 mL empty IV fluid bags because a limited number were found to leak during filling, which could result in contamination during fluid administration.
Product
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0394-2025·2024-11-20
Medical surgical kits recalled due to loose metal flakes
AVID Medical is recalling Halyard TOTAL KNEE surgical kits (Model EUOR002-05) because sponge forceps and towel clamps may shed small metal flakes that could contaminate surgical sites and cause reactions.
Product
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0438-2025·2024-11-20
Surgical instruments recalled for loose metal flake contamination risk
AVID Medical is recalling Halyard RAD PACK medical convenience kits containing sponge forceps and towel clamps. Small metal flakes may detach and enter surgical sites, potentially causing foreign body or local tissue reactions.
Product
Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0359-2025·2024-11-20
Medline urine collection kits recalled for non-sterile specimen containers
Medline has recalled 626,305 urine collection kits because specimen containers are labeled as sterile but are actually non-sterile, potentially leading to unnecessary treatment or prolonged hospitalization.
Product
URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0396-2025·2024-11-20
Halyard SPINE Kit recalled for loose metal flakes in surgical instruments
AVID Medical is recalling Halyard SPINE surgical kits (Model EUOR004-02) due to loose metal flakes that may detach from sponge forceps and towel clamps. These flakes could potentially enter a patient's surgical site, causing local or foreign body reactions.
Product
Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0435-2025·2024-11-20
Halyard C Section Pack surgical kits recalled for loose metal flakes
AVID Medical is recalling Halyard C Section Pack surgical kits due to loose metal flakes on sponge forceps and towel clamps. These flakes may enter a surgical site and cause local reactions or foreign body complications.
Product
Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0334-2025·2024-11-20
IV Bag Containers Recalled for Leaking During Filling Process
The Metrix Company is recalling CORMIX 500 mL IV bag containers that may leak during the filling process. These plastic pouches are intended for intravenous fluid administration.
Product
CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0446-2025·2024-11-20
Halyard EP TRAY Surgical Kits Recalled for Loose Metal Flakes
AVID Medical is recalling Halyard EP TRAY surgical convenience kits due to sponge forceps and towel clamps that may shed small metal flakes. These flakes could enter surgical sites, potentially causing local or foreign body reactions.
Product
Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0338-2025·2024-11-20
IV Fluid Bags Recalled Due to Leakage During Filling
The Metrix Company is recalling SECURE 50 mL empty IV containers due to leakage found during filling. A limited number of affected bags have been distributed nationwide.
Product
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0431-2025·2024-11-20
Halyard CPT Cardiac Cath Pack Recalled Due to Loose Metal Flakes in Forceps and Clamps
AVID Medical is recalling Halyard CPT Cardiac Cath Pack convenience kits due to small metal flakes that may detach from sponge forceps and towel clamps. Metal flakes could enter a surgical site undetected and cause local or foreign body reactions.
Product
Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0358-2025·2024-11-20
Medline Urine Collection Kits Recalled Due to Non-Sterile Specimen Containers
Medline Industries recalls 626,305 urine collection kits with non-sterile specimen containers labeled as sterile. The kits may cause unnecessary treatment or prolonged hospitalization.
Product
URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0405-2025·2024-11-20
Halyard GYN TRAY surgical kits recalled for loose metal flakes
AVID Medical is recalling 136 units of Halyard GYN TRAY surgical kits due to small loose metal flakes that could detach from sponge forceps and towel clamps. These metal fragments could enter a patient's surgical site undetected, causing local or foreign body reactions.
Product
Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0461-2025·2024-11-20
MEERA CL operating table may stop unexpectedly during surgical procedures
The MEERA CL operating table may experience error code 50037 on its IR-Hand Control, causing the table to stop mid-procedure. No injuries have been reported.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B2
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0460-2025·2024-11-20
FDA Recalls MEERA CL Mobile Operating Tables for Unintended Movement Stops
Getinge Usa Sales Inc is recalling 112 MEERA CL mobile operating tables because error code 50037 may cause the table to stop moving unexpectedly when controlled via IR hand control, resulting in procedural delays.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B0
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0350-2025·2024-11-20
Medline arthroscopy surgical kits recalled for incomplete packaging seal
Medline Industries is recalling 80 arthroscopy surgical convenience kits due to incomplete packaging seals. The affected lot numbers are 24GBI464 and 24HBO800.
Product
ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0363-2025·2024-11-20
Karl Storz Irrigation Tubing Recalled for Unapproved Label Use
Karl Storz Endoscopy is recalling Irrigation Tubing for the Endomat Select UP210 because its label claims an intended use that the FDA has not approved for U.S. distribution.
Product
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0227-2025·2024-11-13
Elekta Disposable Biopsy Needles Recalled for Internal Debris Contamination
Elekta recalls disposable biopsy needles for the Leksell Stereotactic System due to microscopic stainless steel debris found inside the needles. 111 kits (666 needles) distributed across multiple U.S. states are affected.
Product
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465,
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0287-2025·2024-11-13
Surgical neurological sponges recalled for detaching X-ray markers
American Surgical Company is recalling 390 units of Americot 20-01S neurological sponges used in surgery. The X-ray detectable barium strip may detach, potentially delaying the surgical process.
Product
Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0323-2025·2024-11-13
Electrocardiograph DICOM Files Risk Patient Data Mismatch Due to Duplicate Identifiers
Certain Hillrom Welch Allyn Vision Express Holter Analysis Systems may assign duplicate identifiers to cardiac exam files, risking mismatch between patient identities and their physiological data.
Product
Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0318-2025·2024-11-13
GE Healthcare Centricity Viewer Security Vulnerability Could Allow Unauthorized Access
GE Healthcare's Centricity Universal Viewer Zero Footprint medical imaging software contains a security vulnerability that could allow unauthorized access and patient data manipulation. Approximately 120 units are affected worldwide.
Product
GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02268286, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02030900, 1495-1-Centric
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0325-2025·2024-11-13
Cardiac stress testing system may assign duplicate exam identifiers to patients
Hillrom Welch Allyn XScribe cardiac stress testing systems may assign duplicate exam identifiers, potentially causing patient data mismatches in medical record systems.
Product
Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0308-2025·2024-11-13
DeRoyal Children's Orthopedic Tracepack Smoke Evacuation Pencil Malfunction Recall
DeRoyal is recalling 384 units of Children's Orthopedic TracePacks containing a Stryker smoke evacuation pencil that may activate unexpectedly or fail to deactivate, posing a burn risk during surgery.
Product
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0320-2025·2024-11-13
Hillrom HScribe Holter System cardiac monitoring devices duplicate identifier risk
Hillrom HScribe Holter System monitoring devices may assign duplicate file identifiers, risking patient identification mismatches in medical systems that use the identifier to match patient data to cardiac recordings.
Product
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0285-2025·2024-11-13
Endoscopic Vessel Harvesting System Recalled for Assembly Defect
Zimmer recalls the Venapax XL endoscopic vessel harvesting system due to assembly defects that may cause endoscope interference during surgery. A Gen 5 tail piece was incorrectly assembled to Gen 4 devices, affecting 432 units nationwide.
Product
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. Item Number: VPX4000 (7273)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0326-2025·2024-11-13
Smith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring
Smith & Nephew is recalling 21 units of a Tandem Bipolar Hip System component due to an oversized retainer ring in the femoral head assembly. The affected devices were distributed internationally to nine countries.
Product
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
Category
Medical Device
Distribution
0 states

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4626–4650 of 13543