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

11376–11400 of 13717

HighFDA (Devices)·Z-1402-2022·2022-07-27
Stryker Triton Canister Scanning Labels Recalled Due to Color Variance
Stryker is recalling Triton Canister Scanning Labels that may have color variance issues, potentially resulting in lower-than-expected blood loss estimates. The recall affects 16,700 units distributed nationwide.
Product
Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1443-2022·2022-07-27
Spinal Fusion Implant Cross Connectors Recalled for Insufficient Clamping Force
Aesculap is recalling its S4 Cervical Cross Connector used in spinal fusion surgery due to insufficient clamping force that may cause the connectors to move on the rods or shed particles.
Product
AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1426-2022·2022-07-27
Sensis Vibe Combo Device Recalled for Software Communication Failure
The Sensis Vibe Combo diagnostic system may experience communication failure during patient procedures, causing vital signs data to be unavailable. The recall affects 13 units distributed across multiple U.S. states.
Product
Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1388-2022·2022-07-27
Hobbs Medical Polypectomy Snare May Fail to Close Properly
Hobbs Medical Polypectomy Snares (Catalog No. 7202) may accordion at the proximal end, preventing full closure and potentially causing injury. Specific lots distributed to medical facilities in NC, TX, WA, and Canada are affected.
Product
Hobbs Medical Polypectomy Snare, Catalog No. 7202
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1435-2022·2022-07-27
BD Connecta Stopcock Without Extension Tube Recalled for Potential Leakage Risk
Becton Dickinson & Company is recalling BD Connecta Stopcock units worldwide due to a potential housing leakage defect that could interrupt treatment or cause exposure to biohazardous material.
Product
BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1439-2022·2022-07-27
BD Connecta Plus3 infusion connector recalled for potential stopcock leakage
Becton Dickinson is recalling BD Connecta Plus3 White Blend infusion connectors (Lot 1127328) due to potential stopcock leakage. The defect may interrupt treatment, expose patients to biohazardous material, or cause under-infusion.
Product
BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)
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-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-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-1445-2022·2022-07-27
Spinal fusion cross connector recalled for insufficient clamping force
Aesculap is recalling AESCULAP S4 Cervical Cross Connectors used in spinal fusion surgery due to insufficient clamping force that may cause the connectors to loosen or shift on the spinal rods.
Product
AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery.
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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-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-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-1428-2022·2022-07-27
Spinal Fixation Device Removal Key Recalled Due to Potential Fracture Risk
Aesculap Implant Systems recalls ENNOVATE MIS REMOVALKEY SHORT due to fracture risk if removal key is not used at 90-degree angle. Affected units distributed in CA, CO, IL, MI, OH, and TX.
Product
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
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-1410-2022·2022-07-27
Modulift VBR Surgical Screwdriver Fails Due to Tip Deformation
Aesculap is recalling the Modulift VBR 4MM set screwdriver due to tip deformation during surgical engagement with implants. The device is distributed in CA, FL, GA, IL, OH, and MI.
Product
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Category
Medical Device
Distribution
6 states
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-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-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-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-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-1429-2022·2022-07-27
Spinal fixation removal key fracture risk under misuse conditions
The ENNOVATE MIS removal key used in spinal fixation systems may fracture if the 90-degree angle is not maintained during use. A product redesign is underway.
Product
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Category
Medical Device
Distribution
Distributed nationwide

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11376–11400 of 13717