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

12926–12950 of 13837

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-2576-2021·2021-10-06
Vysis CLL FISH Probe Kit may fail to detect genetic deletion
Abbott is recalling Vysis CLL FISH Probe Kits that may not detect 13q deletions in patient samples. This could lead to missed diagnosis of a genetic abnormality used in cancer treatment planning.
Product
Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes
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
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-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-2546-2021·2021-10-06
Outlook Pump IV Sets Recalled for Leakage and Infection Risk
B. Braun Medical, Inc. is recalling approximately 44,866 Outlook Pump IV sets due to leakage of the pump set that could delay medication administration and increase the risk of bloodstream infections. The defect may result in under-delivery or incomplete medication dosing.
Product
Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354214
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2553-2021·2021-10-06
B. Braun Outlook Pump Set Recall: Risk of Leakage and Medication Under-Delivery
B. Braun is recalling 1,752 Y-Type Blood Outlook Pump Set units due to leakage in the cassette portion. The defect may cause delays in medication administration, incomplete dosing, or bloodstream infections.
Product
Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2601-2021·2021-10-06
Patient lift devices may lose ability to maintain horizontal positioning during transfers
Hill-Rom LikoStretch Mod 600 IC patient lift devices may fail to maintain patients in a horizontal position while lifting, potentially causing patients to slide or fall.
Product
LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - 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-2609-2021·2021-10-06
Corin MetaFix Hip Stem Recalled Due to Potential Packaging Damage
Corin Ltd is recalling Corin MetaFix Hip Stem, Size 1 devices due to potential physical and water damage to packaging that could compromise device sterility and cause contamination.
Product
Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.
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

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12926–12950 of 13837