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

4476–4500 of 13449

HighFDA (Devices)·Z-0365-2025·2024-11-20
Stryker Neptune SafeAir Electrosurgical Pencil Recalled for Unintended Activation Risk
Stryker has recalled over 1.1 million Neptune SafeAir Smoke Evacuation Pencils due to potential unintended activation that may cause electrical burns to patients and surgical staff. The device may activate without user input or remain active after buttons are released.
Product
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0425-2025·2024-11-20
Halyard Urology Laparotomy Pack surgical instruments recalled for detachable metal flakes
AVID Medical recalls Halyard Urology Laparotomy Pack surgical instruments (Model SAMM023-13, Lot 1595070) due to loose metal flakes that could detach from forceps and clamps, potentially entering surgical sites and causing foreign body reactions.
Product
Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-13
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0434-2025·2024-11-20
Surgical instrument kits recalled for loose metal flakes
AVID Medical is recalling Halyard CPT EP PACK surgical convenience kits due to loose metal flakes on forceps and towel clamps. Detached metal flakes could enter surgical sites and potentially cause local tissue reactions or foreign body complications.
Product
Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0364-2025·2024-11-20
Olympus UroPass Ureteral Access Sheaths recalled for UV-induced brittleness
Olympus is recalling UroPass Ureteral Access Sheaths because ultraviolet radiation exposure can cause the dilator tip to become brittle and break during surgery or in storage. Approximately 14,093 units have been distributed worldwide.
Product
Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0424-2025·2024-11-20
Halyard Vaginal Gyn Pack Recalled Due to Loose Metal Flakes Risk
AVID Medical is recalling the Halyard MAJOR VAGINAL GYN PACK due to sponge forceps and towel clamps that may shed loose metal flakes. These flakes could enter a surgical site undetected, causing local reactions or foreign body reactions.
Product
Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0369-2025·2024-11-20
Stryker Neptune SafeAir smoke evacuation pencil recalled for unintended activation
Stryker Corporation is recalling 21,490 Neptune SafeAir Smoke Evacuation Pencils due to risk of unintended activation that could cause electrical burns. The device may activate without user input or remain active after buttons are released.
Product
Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0454-2025·2024-11-20
Medical convenience kits recalled due to detachable metal flakes
AVID Medical is recalling Halyard PACEMAKER PK medical convenience kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.
Product
Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0387-2025·2024-11-20
Halyard Open Heart Surgical Kits Recalled for Loose Metal Flakes in Instruments
AVID Medical is recalling Halyard Open Heart Pack Main surgical kits because sponge forceps and towel clamps may contain loose metal flakes that could detach and enter a patient's surgical site.
Product
Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0368-2025·2024-11-20
Stryker Neptune SafeAir Smoke Evacuation Pencil May Activate Unintentionally
Stryker recalls Neptune SafeAir Smoke Evacuation Pencils that may activate without user input, risking electrical burns to patients or healthcare workers. Approximately 1,996,010 units were distributed worldwide.
Product
Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0339-2025·2024-11-20
IV Fluid Container Bags Recalled for Potential Leaks During Filling
The Metrix Company is recalling SECURE 250 mL IV fluid containers due to leaks found during filling. Affected units were distributed nationwide and to Canada.
Product
SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; 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-0332-2025·2024-11-20
IV Fluid Containers Recalled for Leakage Risk During Filling
The Metrix Company is recalling CORMIX 150 mL empty IV fluid containers due to leakage found during filling, which could compromise the integrity of intravenous fluids.
Product
CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; 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-0388-2025·2024-11-20
Halyard AORTA PACK Surgical Kit Recalled for Loose Metal Flakes
Halyard AORTA PACK surgical kits are recalled because sponge forceps and towel clamps may contain loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.
Product
Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0448-2025·2024-11-20
Medical Convenience Kits Recalled for Potential Loose Metal Flakes in Surgical Instruments
AVID Medical is recalling Halyard MANIFOLD CATH PACK medical convenience kits because sponge forceps and towel clamps may shed metal flakes that could contaminate surgical sites.
Product
Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0451-2025·2024-11-20
Surgical forceps and clamps recalled due to potential metal flake contamination
AVID Medical is recalling Halyard ENT surgical convenience kits due to potential metal flakes from forceps and clamps that could enter a patient's surgical site. Metal flakes may cause local or foreign body reactions during surgery.
Product
Halyard ENT - Medical convenience kits Model Number: VMED011-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0389-2025·2024-11-20
Surgical Instruments Recalled for Loose Metal Flakes in Set-Up Packs
AVID Medical is recalling Halyard GENERAL SET UP PACK medical convenience kits nationwide due to sponge forceps and towel clamps that may shed small metal flakes into patients' surgical sites, risking local reactions and foreign body reactions.
Product
Halyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0447-2025·2024-11-20
Halyard Angiography Drape Pack Recalled for Potential Metal Flakes in Surgical Site
AVID Medical recalls Halyard angiography drape packs due to potential metal flakes that could detach from sponge forceps and towel clamps. These flakes could enter a surgical site undetected and cause local or foreign body reactions.
Product
Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0442-2025·2024-11-20
Halyard Pacemaker Instrument Packs Recalled for Loose Metal Flakes
AVID Medical is recalling Halyard Pacemaker Instrument Packs (Model VAPX040-01) because sponge forceps and towel clamps may contain loose metal flakes that could detach and enter a patient's surgical site during procedures.
Product
Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: VAPX040-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0414-2025·2024-11-20
Halyard Surgical Kit Components May Shed Metal Flakes
AVID Medical is recalling Halyard ANGIO ARTERIOGRAM PACK surgical kits due to metal flakes that may detach from forceps and clamps. Metal fragments could enter a patient's surgical site and cause local or foreign body reactions.
Product
Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0390-2025·2024-11-20
Halyard Total Knee Surgical Kit Recalled for Loose Metal Flakes
AVID Medical is recalling Halyard total knee surgical kits due to loose metal flakes on sponge forceps and towel clamps that could enter and contaminate the surgical site. The defect poses a risk of local reactions or foreign body complications.
Product
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0428-2025·2024-11-20
Halyard EYE PLASTIC TRAY Medical Kits Recalled for Loose Metal Flakes
AVID Medical recalls Halyard EYE PLASTIC TRAY medical kits due to loose metal flakes in sponge forceps and towel clamps. Metal flakes may contaminate surgical sites, potentially causing foreign body reactions or local tissue damage.
Product
Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0331-2025·2024-11-20
VYGON 250 mL IV Fluid Containers Recalled for Leaks During Filling
The Metrix Company is recalling VYGON 250 mL IV fluid containers that have been found to leak during filling. Leaking containers cannot properly contain intravenous fluid.
Product
VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; 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-0437-2025·2024-11-20
Surgical Sponge Forceps and Towel Clamps Recalled for Loose Metal Flakes
AVID Medical is recalling Halyard CATH LAB PACK surgical kits because sponge forceps and towel clamp components may shed loose metal flakes that could enter a patient's surgical site, posing a risk of local or foreign body reactions.
Product
Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0371-2025·2024-11-20
Venclose RF Ablation Catheters Recalled for Wiring Defect Causing Excessive Heat
Bard Peripheral Vascular's Venclose RF ablation catheters may have swapped signal wires causing excessive heating. The defect can lead to temperatures exceeding therapeutic levels, increasing risk of thermal injury.
Product
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0342-2025·2024-11-20
IV Fluid Bags Recalled Due to Leaking During Filling
The FDA is recalling Imed EVA BAG IV bags after a limited number were found to leak during filling. The affected bags were distributed nationwide and in Canada.
Product
Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; 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-0370-2025·2024-11-20
Stryker Smoke Evacuation Pencils Recalled for Unintended Activation Risk
Stryker is recalling 403,730 Neptune SafeAir Smoke Evacuation Pencil units because they may activate unexpectedly when plugged in, creating a risk of electrical burns to patients and physicians.
Product
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuatio
Category
Medical Device
Distribution
Distributed nationwide

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4476–4500 of 13449