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

12876–12900 of 13802

HighFDA (Devices)·Z-2589-2021·2021-10-06
Atrium ADVANTA VXT Vascular Graft may lack required radial support ring
Atrium Medical Corporation is recalling 28 units of the Atrium ADVANTA VXT Vascular Graft because some packages may contain mismatched units lacking the radial support ring specified in labeling.
Product
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2545-2021·2021-10-06
B. Braun Outlook Pump Sets recalled for potential leakage and infection risk
B. Braun is recalling 585,576 Outlook Pump Sets due to potential leakage in the cassette portion. The defect may cause medication under-delivery and increase bloodstream infection risk.
Product
Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Material ID: 352413
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2561-2021·2021-10-06
Fluid management system control unit display freeze during hysteroscopic procedures
A software defect in the Covidien HysteroLux fluid management system causes the display to freeze at a specific volume threshold during hysteroscopic surgery, creating risk of improper fluid accounting and potential circulatory complications.
Product
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2596-2021·2021-10-06
GE Healthcare anesthesia machine flow sensors may over-deliver anesthetic
Flow sensors in GE Healthcare anesthesia machines built before June 2021 may have damaged tubing that leaks, potentially causing over-delivery of anesthetic to patients.
Product
Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva 7100; (4) Aespire System Carestation, S/5 Protiva Config., Aespire 100 Compact Wall Mount (Aespire 7100); (5) S/5 Aespire 7900;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2558-2021·2021-10-06
Outlook Pump Add-On Set Recalled for Potential Leakage and Under-Delivery
B. Braun Medical is recalling the Outlook Pump Add-On Set due to potential leakage that may delay medication delivery and cause incomplete dosing. The affected units could increase the risk of bloodstream infections.
Product
Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2552-2021·2021-10-06
B. Braun Outlook IV Pump Sets Recalled Due to Leakage Risk
B. Braun Medical is recalling Outlook pump IV sets used with specific infusion pumps due to leakage in the cassette portion. The defect may prevent proper medication delivery and pose a risk of bloodstream infection.
Product
OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 474004
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2543-2021·2021-10-06
Carotid and Gelsoft vascular patches recalled for incorrect instructions
Vascutek vascular patches were distributed with rest-of-world instructions instead of U.S. instructions. The 159 units distributed to Puerto Rico and Guam have incorrect Instructions for Use for U.S. use.
Product
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2606-2021·2021-10-06
Corin Trinity Liner hip implant components recalled due to packaging damage
Corin Ltd is recalling specific Trinity Liner ECIMA hip implant components because packaging damage could compromise device sterility or cause contamination. Five units were distributed nationwide between July 22-26, 2021.
Product
Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner ECIMA, diameter 36mm Neutral 4mm EPW, Taper Size 4 (Elevated Wall), REF 322.04.936, Sterile; both are components of the Trinity Acetabular System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2615-2021·2021-10-06
Cardiosave Hybrid IABP may unexpectedly shut down on AC power
The Cardiosave Hybrid Intra-Aortic Balloon Pump may unexpectedly shut down when running on AC power with one battery installed and the battery removed during charging. No injuries have been reported.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2548-2021·2021-10-06
Infusion Pump Sets Recalled for Leakage and Medication Under-Delivery Risk
B. Braun Medical is recalling infusion pump sets that may leak, potentially causing delayed medication delivery, incomplete dosing, and bloodstream infections.
Product
10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2603-2021·2021-10-06
Corin TriFit TS Orthopedic Implant Recall Due to Packaging Damage and Sterility Loss
Corin Ltd is recalling Corin TriFit TS orthopedic implants due to packaging damage that may cause sterility loss and device contamination. The affected devices were shipped in July 2021 to multiple US states.
Product
Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2542-2021·2021-10-06
Vascutek Vascular Grafts Recalled for Incorrect Instructions for Use
Vascutek is recalling vascular grafts distributed to Puerto Rico and Guam that contained wrong Instructions for Use prepared for international rather than U.S. consignees. Improper instructions pose a risk of incorrect device use.
Product
The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts: (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthe
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2574-2021·2021-10-06
NAMIC Angiographic Manifolds Recalled for Potential Sterile Barrier Compromise
Medline Industries recalled 816,420 NAMIC Angiographic Manifolds due to potential microscopic pinholes in sterile pouches that could compromise device sterility. No injuries reported.
Product
NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile; (2) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038303, UPN H965640383031, 3 Valve Manifold,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2549-2021·2021-10-06
Outlook Pump Measured Volume Solution Set recalled for cassette leakage
B. Braun is recalling 940 units of Outlook Pump Measured Volume Solution Sets due to potential leakage in the cassette. The leakage could delay medication delivery, result in incomplete dosing, or lead to bloodstream infections.
Product
Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 375118
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2590-2021·2021-10-06
Mobile X-Ray System Recalled for Unexpected Column Motion During Parking
GE Healthcare is recalling the AMX Navigate Mobile X-Ray System due to an unexpected column motion defect that occurs during parking operations. Three units distributed in the United States are affected.
Product
AMX Navigate Mobile X-Ray System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2579-2021·2021-10-06
PAS-PORT Proximal Anastomosis Device recalled for deployment failure risk
Aesculap Implant Systems is recalling the PAS-PORT Proximal Anastomosis Device because the implant may fail to deploy successfully, potentially requiring additional medical intervention during surgery.
Product
PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2581-2021·2021-10-06
Dose Calibrator Software Bug May Cause Incorrect Isotope Measurements
AtomLab 500Plus Dose Calibrator software versions 2.0.00–2.0.08 contain a bug that fails to remove dial settings when deleting custom isotopes, potentially causing incorrect dose calibrations and misadministration.
Product
AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2607-2021·2021-10-06
Corin BIOLOX Delta Mod Head hip implant components recall due to packaging damage
Corin Ltd is recalling Corin BIOLOX Delta Mod Head hip implant components due to packaging system damage that could result in loss of sterility or device contamination. Affected units were distributed nationwide to nine states.
Product
Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2562-2021·2021-10-06
LYMOL Medical Elite X Class Rigid Bronchoscope System — Updated reprocessing instructions not distributed
Lymol Medical Corporation recalled the LYMOL Medical Elite X Class Rigid Bronchoscope System because updated reprocessing instructions issued November 15, 2020, were not sent to all consignees of the devices.
Product
LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2597-2021·2021-10-06
Patient lift device may lose horizontal positioning control, creating fall risk
The OctoStretch with Stretch Leveller may lose its ability to keep patients horizontal during lifting, risking patient falls. 440 units were distributed worldwide.
Product
OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Model Number: 3156056
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2559-2021·2021-10-06
Outlook Pump Primary Administration Set Recalled for Potential Leakage and Medication Underdosing
B. Braun Medical is recalling the Outlook Pump Primary Administration Set due to potential leakage that could delay medication delivery and cause incomplete dosing of critical fluids in epidural administration.
Product
Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7453
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2585-2021·2021-10-06
Operating Room Table Rotational Lock May Fail to Function
Deerfield Imaging operating room tables (ORT200/300) may have a mechanical defect in the rotational lock, preventing it from changing between locked and unlocked states. This could affect patient positioning during procedures.
Product
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2612-2021·2021-10-06
Corin Unity Knee Patella components recalled due to packaging damage
Corin is recalling Corin Unity Knee Patella components due to potential packaging damage that could compromise sterility and device integrity. Affected units were distributed in nine US states in July 2021.
Product
Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a component of the Unity Total Knee System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2586-2021·2021-10-06
Operating room table rotational lock may fail to maintain position
The rotational lock on certain operating room tables may fail to secure the table position. This could cause the table to move unexpectedly during diagnostic or surgical procedures.
Product
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2602-2021·2021-10-06
DxA 5000 Automation System Recalled Due to Sample Containment Defect
Beckman Coulter is recalling 123 DxA 5000 automation systems due to a sample containment defect that may cause samples to drop, delaying patient treatment and risking biohazard exposure. Affected units were distributed to eleven states.
Product
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
Category
Medical Device
Distribution
Distributed nationwide

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12876–12900 of 13802