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

5376–5400 of 39968

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-0333-2025·2024-11-20
IV Bag Containers Recalled Due to Leaking During Filling
The FDA has recalled CORMIX 250 mL empty IV bags made by The Metrix Company due to leaking during the filling process. Approximately 3,456 cases were distributed across the US and Canada.
Product
CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; 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-0465-2025·2024-11-20
Medline Iris Scissors Recalled for Potential Sterility Barrier Compromise
Medline is recalling 69,611 single-use iris scissors because the tip protector may fall off during packaging, compromising the sterile barrier. Affected units were distributed nationwide to 20 states.
Product
Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0398-2025·2024-11-20
Halyard FOOT ANKLE PACK surgical instruments recalled due to loose metal flakes
AVID Medical recalls Halyard FOOT ANKLE PACK surgical kits due to loose metal flakes from sponge forceps and towel clamps that could enter surgical sites and cause local reactions.
Product
Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02
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-0335-2025·2024-11-20
IV Fluid Container Bags Recalled for Leaking Defect
The Metrix Company is recalling SECURE 100 mL empty EVA containers for IV use due to leaking discovered during filling. Approximately 2,229 cases were distributed to healthcare facilities in the US and Canada.
Product
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; 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-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-0397-2025·2024-11-20
Halyard surgical kit recalled for loose metal flakes in forceps and clamps
AVID Medical is recalling Halyard KIT, SPINE surgical convenience kits due to loose metal flakes on sponge forceps and towel clamps. The flakes could detach and enter a patient's surgical site, potentially causing local or foreign body reactions.
Product
Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0433-2025·2024-11-20
Surgical forceps and clamps recalled due to detachable metal flakes
AVID Medical is recalling Halyard CPT surgical convenience kits because sponge forceps and towel clamps may shed small metal flakes that could contaminate surgical sites. No illnesses have been reported.
Product
Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07
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-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-0423-2025·2024-11-20
Halyard Laparotomy GYN Packs recalled due to loose metal flakes
AVID Medical recalls Halyard LAPAROTOMY GYN surgical packs due to loose metal flakes on sponge forceps and towel clamps. Metal fragments may enter the surgical site and cause local or foreign body reactions.
Product
Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13
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-0413-2025·2024-11-20
Halyard Pacemaker Pack surgical kits recalled for loose metal flakes
AVID Medical is recalling Halyard Pacemaker Pack surgical kits because sponge forceps and towel clamps contain loose metal flakes that could detach and enter patient surgical sites.
Product
Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0444-2025·2024-11-20
Halyard IVR Vascular Pack Surgical Instruments Recalled for Loose Metal Components
AVID Medical is recalling Halyard IVR Vascular Pack surgical kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site.
Product
Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08
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-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-0410-2025·2024-11-20
Halyard Knee Arthroscopy Packs recalled due to loose metal flakes
AVID Medical recalls Halyard Knee Arthroscopy Packs due to loose metal flakes that could detach from forceps and clamps. Metal fragments may enter the surgical site, potentially causing local or foreign body reactions.
Product
Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0348-2025·2024-11-20
Baxter Spectrum IQ Infusion Pump Door May Not Close Fully
Baxter is recalling 8 units of its Spectrum IQ Infusion System with Dose IQ Safety Software because the pump door may not fully close. The recall affects units distributed in Georgia and Idaho.
Product
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0343-2025·2024-11-20
Imed EVA IV Fluid Bags Recalled Due to Leakage During Filling
The Metrix Company is recalling Imed EVA IV fluid bags that may leak during filling. A limited number of units have been found defective across multiple U.S. states and Canada.
Product
Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; 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-0351-2025·2024-11-20
Cystoscope Outer Sheath Recalled for Potential Laser Probe Damage
Olympus is recalling 738 units of the WA22810A Cystoscope Outer Sheath distributed nationwide due to potential damage to the laser probe tip during use with GreenLight Laser for BPH therapy. The manufacturer removed this compatibility claim from product instructions.
Product
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0354-2025·2024-11-20
Clean Catch Kit specimen containers recalled for sterility labeling failure
Medline recalls 626,305 Clean Catch Kits whose specimen containers are non-sterile despite sterile labeling, risking specimen contamination and unnecessary treatment.
Product
Clean Catch Kit, SKU DYKM1833A; Component No. 503581
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0391-2025·2024-11-20
Halyard Shoulder Medical Kit recalled for loose metal flakes in surgical components
AVID Medical is recalling Halyard shoulder surgical kits due to loose metal flakes that could detach and enter surgical sites. Metal debris could cause local or foreign body reactions.
Product
Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0383-2025·2024-11-20
Medical Drainage Pack Components Recalled for Potential Metal Fragments
AVID Medical is recalling the Halyard IR Abcess Drainage Pack due to sponge forceps and towel clamps that may have loose metal flakes. Metal flakes could detach and enter a patient's surgical site, causing local or foreign body reactions.
Product
Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018
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

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