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 the agency’s own highest classification or reported deaths or serious injuries, 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

10876–10900 of 27441

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…
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-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-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-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-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-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-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-2584-2021·2021-10-06
Operating Room Table Rotational Lock May Fail Due to Hardware Defect
The rotational locking mechanism on certain ORT200/300 operating room tables may fail to lock or unlock due to a mechanical hardware defect. Affected tables have been distributed worldwide.
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-2611-2021·2021-10-06
Corin Unity Knee Implant Components Recalled for Packaging Damage Risk
Corin Ltd recalls two models of Unity Knee CS Insert implant components due to potential packaging damage that could compromise sterility or cause contamination. Affected devices were distributed in nine U.S. states in July 2021.
Product
Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size 8 / 10.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125243, Sterile, both are components of the Unity Total Knee System.
Category
Medical Device
Distribution
Distributed nationwide
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-2547-2021·2021-10-06
B. Braun Infusion Pump Sets Recalled Due to Cassette Leakage Risk
B. Braun Medical is recalling 1,960 infusion pump sets used with Outlook Safety and Horizon NXT systems due to leakage in the cassette portion, which may delay medication delivery and increase bloodstream infection risk.
Product
60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2551-2021·2021-10-06
Outlook V1500HP Pump Set Recalled for Cassette Leakage
The Outlook V1500HP Pump Set is recalled due to cassette leakage that could delay medication delivery, reduce dosing accuracy, and cause bloodstream infections. The recall involves 12,000 units distributed in the US and Canada.
Product
V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470025
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-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…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2555-2021·2021-10-06
B. Braun Pump Set Cassette Leakage Risks Medication Delivery
B. Braun Medical recalls 13,320 pump sets due to cassette leakage that may delay medication administration and cause incomplete dosing or bloodstream infections.
Product
PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 480239
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2580-2021·2021-10-06
Atomlab 500 Dose Calibrator Software Recall for Incorrect Dose Measurement
Biodex Medical Systems is recalling Atomlab 500 Dose Calibrator Software versions 2.0.00 through 2.0.08 due to a software defect that can cause incorrect dose measurements and potential misadministration of radioactive material.
Product
Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2588-2021·2021-10-06
Arjo Citadel Beds: Power Cord Wear May Cause Electrical Hazard
Certain Arjo Citadel medical beds with IndiGo power cords may develop wear during normal use, potentially causing electrical short circuits and fire hazards. Units manufactured from May 2018 through February 2021 are affected.
Product
Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) or Enterprise (model no. INDIJAA) beds manufactured without IndiGo modules…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2610-2021·2021-10-06
Corin Unity Knee Augments Recalled Due to Packaging Damage and Sterility Loss
Corin Ltd is recalling Corin Unity knee implant augments because packaging damage could compromise device sterility and allow contamination. Affected units were distributed in 9 states during July 2021.
Product
Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2550-2021·2021-10-06
Outlook pump extension sets recalled due to leakage and dosing errors
Outlook infusion pump extension sets may leak, potentially delaying medication delivery and causing bloodstream infections.
Product
ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470024
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2565-2021·2021-10-06
Olympus BF-3C40 OES Bronchofiberscope Recall: Reprocessing Instructions Updated
Olympus is recalling approximately 484 BF-3C40 OES Bronchofiberscopes due to reprocessing instruction updates. The manufacturer is issuing validated instructions per FDA 2015 guidance for proper device reprocessing.
Product
BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2604-2021·2021-10-06
Corin Trinity Bone Screws Recalled for Potential Packaging Damage and Sterility Loss
Corin Ltd is recalling specific lots of Trinity Acetabular System bone screws due to potential packaging damage that could result in loss of sterility or device contamination.
Product
Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, diameter 6.5mm 50mm Length, Cancellous Bone Screw, REF 321.050, Sterile, both are components of the Trinity Acetabular System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2560-2021·2021-10-06
Blood Administration Pump Set Recalled Due to Leakage Risk
B. Braun Medical is recalling Outlook Pump Blood Administration Sets due to leakage in the pump cassette that could delay or prevent complete medication delivery and increase infection risk.
Product
Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: NF3120
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2600-2021·2021-10-06
Patient Lift Device Stretch Leveller May Lose Horizontal Position Control
Hill-Rom LikoStretch 1900 patient lift devices may lose their ability to maintain horizontal position during lifting, risking patient falls. Affected devices can cause patients to slide out of the lift sheet.
Product
LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2605-2021·2021-10-06
Corin Trinity-i Acetabular Components Recalled Due to Packaging Damage
Corin Ltd is recalling Corin Trinity-i acetabular components (50mm diameter, Taper Size 3) distributed nationwide due to potential physical and water damage to the packaging system, which may compromise device sterility or cause contamination.
Product
Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular System.
Category
Medical Device
Distribution
Distributed nationwide

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10876–10900 of 27441