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

11476–11500 of 13816

HighFDA (Devices)·Z-1425-2022·2022-07-27
Sensis diagnostic tool software may fail to display vital signs
Siemens' Sensis diagnostic tool may lose communication and fail to display vital signs during initial patient exams or after inactivity. Software updates are required.
Product
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1436-2022·2022-07-27
BD Connecta 3-Way Stopcocks Recalled Due to Potential Leakage
Becton Dickinson recalls BD Connecta 3-Way Stopcocks due to potential leakage at the housing that may delay treatment and expose patients to biohazardous material.
Product
BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1449-2022·2022-07-27
Aesculap Sterile Disposable Fleece Drape Recalled Due to Packaging Seal Integrity Issue
Aesculap recalls 4500 sterile disposable fleece drapes (Product code GA414) due to unvalidated packaging seal integrity, which may compromise sterility assurance. Distribution occurred in 14 U.S. states.
Product
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1446-2022·2022-07-27
Cervical spinal implant connectors may have insufficient clamping force
Aesculap S4 Cervical Cross Connectors used in spinal fusion surgery may have insufficient clamping force, potentially causing movement of the connectors on the rods or wear debris.
Product
AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1396-2022·2022-07-27
Surgical Seal Packaging May Compromise Sterility in Laparoscopic Devices
Surgical Innovations Ltd recalls YelloPort Elite Universal Seals due to potential holes in packaging that may affect product sterility. Worldwide distribution affected.
Product
YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1419-2022·2022-07-27
Orthopedic Surgical Guide with Defective Spring Subject to Corrosion
DePuy Orthopaedics is recalling 872 units of the ATTUNE Measured Sizing and Rotation Guide due to a manufacturing defect. A galvanized steel spring was used instead of stainless steel, which may cause corrosion and surgical complications.
Product
ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1437-2022·2022-07-27
BD Connecta Plus1 360 Infusion Connector: Potential Housing Leakage
Becton Dickinson is recalling certain BD Connecta Plus1 360 Blue Blend infusion connectors due to potential leakage at the housing stopcock that could interrupt treatment and expose patients to contamination and biohazardous material.
Product
BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1450-2022·2022-07-27
LumiraDx SARS-CoV-2 Antibody Test Strip Modified Outside Approved Scope
LumiraDx recalled SARS-CoV-2 Antibody Test Strips after discovering modifications were made outside the FDA-approved Emergency Use Authorization scope. The recall affects 635 units in 13 states.
Product
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1433-2022·2022-07-27
BD Connecta Stopcock Recalled for Potential Housing Leakage
Becton Dickinson is recalling approximately 1.96 million BD Connecta Stopcock devices due to potential leakage at the housing component, which could interrupt treatment and expose patients to biohazardous material.
Product
BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1448-2022·2022-07-27
Cervical spinal implant connectors may fail to maintain proper clamping force
Aesculap Implant Systems has recalled certain cervical spine implant connectors due to insufficient clamping force. The defect may allow movement on the rods or cause microparticle abrasion.
Product
AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1421-2022·2022-07-27
Medical Device Thawing Kit Recalls Due to Spanish Instruction Translation Error
CooperSurgical recalls its LifeGlobal Fast Freeze Thawing Kit due to a Spanish instruction translation error that specifies 5 minutes instead of 5 seconds for blastocyte air thawing, affecting 403 units.
Product
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-1416-2022·2022-07-27
Hill-Rom Centrella Pro+ mattress reduced heat-moisture management performance
Affected Hill-Rom Centrella Pro+ 36-inch mattresses may have reduced Microclimate Management performance, increasing risk of pressure ulcer development. The failure affects heat and moisture control.
Product
Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1427-2022·2022-07-27
GE Anesthesia Systems Base Cracking and Fall Hazard Recalled
GE Healthcare anesthesia systems may develop cracks in the base, potentially causing the device to tip and fall. The FDA recalled 667 units distributed across multiple U.S. states and countries.
Product
GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1403-2022·2022-07-27
Radiation treatment planning software fails to propagate treatment course data
RayStation 9B SP1 radiation treatment planning software has an issue where treatment course information may not be propagated to other systems in some workflows. This could potentially affect treatment planning accuracy.
Product
RayStation 9B SP1. For radiation treatment planning.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1387-2022·2022-07-27
SX-One MicroKnife Recalled for Potential Dull Blade Defect
Sonex Health LLC is recalling approximately 3,752 SX-One MicroKnife surgical instruments nationwide due to potential blade dulling that may compromise proper function.
Product
SX-One MicroKnife
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1412-2022·2022-07-27
Hill-Rom PRO+ Mattress Microclimate Management Failure Increases Pressure Ulcer Risk
Baxter Healthcare is recalling 404 Hill-Rom PRO+ 36" mattresses due to performance degradation in their heat and moisture management feature. This failure increases the risk of pressure ulcer development in patients.
Product
Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1432-2022·2022-07-27
BD Connecta Stopcock Recalled for Potential Housing Leakage
Becton Dickinson is recalling its BD Connecta Stopcock due to potential leakage at the housing component, which may interrupt treatment and cause exposure to biohazardous material.
Product
BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1406-2022·2022-07-27
Spinal Surgery Instrument Recall: LEFT CORONAL BENDER May Deform Implants
Aesculap Implant Systems LLC is recalling the LEFT CORONAL BENDER (TEK1939) surgical instrument used in spinal procedures because it may deform implants when used with spinal system devices.
Product
LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1441-2022·2022-07-27
Nexiva IV Catheter Stopcock May Leak During Infusion
Becton Dickinson is recalling specific lots of Nexiva IV catheters because the stopcock housing may leak, potentially interrupting treatment and exposing patients to infusate and biohazardous material.
Product
Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1431-2022·2022-07-27
BD Connecta Infusion Stopcock Recall Due to Potential Housing Leakage
BD Connecta Stopcock infusion devices may leak at the housing component, potentially delaying or interrupting treatment and exposing patients to biohazardous material. The recall affects 485,000 units distributed worldwide.
Product
BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1418-2022·2022-07-27
Genesis II Tibial Baseplate Devices Recalled for Packaging Error
Smith & Nephew recalled 31 Genesis II Tibial Baseplate devices that were mispackaged with contents not matching the outer box label. This could result in implanting the wrong-sized component during knee surgery.
Product
(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1440-2022·2022-07-27
Nexiva Infusion Device Stopcock May Leak During Treatment
Becton Dickinson is recalling Nexiva infusion devices with pink stopcock components due to potential leakage at the housing that could interrupt treatment or expose patients to infusate and biohazardous material.
Product
Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1408-2022·2022-07-27
Nonsterile convenience kit recall due to sterile component mislabeling
ROi CPS LLC is recalling 40 nonsterile convenience kits (Lot #92605) because sterile components were incorrectly packaged as nonsterile. The affected kits were distributed in Missouri.
Product
Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1447-2022·2022-07-27
Aesculap S4 Cervical Cross Connector Recalled Due to Clamping Force Defect
Aesculap Implant Systems is recalling the S4 Cervical Cross Connector L 33-42mm due to insufficient clamping force that may cause connector movement or microparticle abrasion in spinal fusion implants.
Product
AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1413-2022·2022-07-27
Hill-Rom Mattress Microclimate Feature Failure Increases Pressure Ulcer Risk
Certain Hill-Rom PRO+ MRS mattresses may have a Microclimate Management feature failure that increases patient pressure ulcer risk. Affected units were distributed to 25+ U.S. states and Canada.
Product
Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.
Category
Medical Device
Distribution
Distributed nationwide

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11476–11500 of 13816