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

12901–12925 of 13802

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-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-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 asse
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2616-2021·2021-10-06
Cardiosave Rescue IABP may unexpectedly shut down during operation
Datascope Corp. is recalling the Cardiosave Rescue IABP (models 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85) because the device may unexpectedly shut down when run on AC power with a single battery installed and that battery is removed during charging.
Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
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-2575-2021·2021-10-06
NAMIC Stopcocks Recalled Due to Potential Sterile Barrier Breach
Medline Industries is recalling NAMIC Stopcocks due to potential sterile barrier breaches from microscopic pinholes in sterile pouches, which could allow non-sterile conditions.
Product
NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (2) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015003, UPN H965700150031, Three-Way Stopcock with Fixed Male Luer Lock, Rx only, S
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-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-2556-2021·2021-10-06
Outlook Pump Set Infusion System Recalled for Leakage and Medication Delivery Risk
B. Braun is recalling 7,248 units of Outlook Pump Set that may leak or fail to deliver medications properly, potentially causing bloodstream infections.
Product
OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361
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-2569-2021·2021-10-06
Bronchovideoscope Reprocessing Instructions Updated for Sterilization Compliance
Olympus Corporation is issuing updated reprocessing instructions for the BF-XP160F EVIS EXERA Bronchovideoscope according to FDA 2015 guidance. All serial numbers are affected.
Product
BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2578-2021·2021-10-06
Aesculap PAS-PORT Surgical Implant Recalled for Deployment Failure
Aesculap Implant Systems is recalling 80 units of the PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM because the implant may fail to deploy during surgery, potentially requiring additional medical intervention.
Product
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2598-2021·2021-10-06
Medical Device: FlexoStretch Patient Lift Leveller May Lose Function During Patient Transfer
Hill-Rom's FlexoStretch Model 3156057 patient lift device may lose the ability to maintain horizontal positioning during patient transfer, risking patient falls. The FDA Class II recall affects 129 units distributed worldwide.
Product
FlexoStretch Model Number: 3156057 - 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-2554-2021·2021-10-06
Outlook Pump IV Set Recalled Due to Cassette Leakage and Infection Risk
B. Braun Medical is recalling Outlook Pump IV Sets due to cassette leakage that may delay medication delivery and cause incomplete dosing or bloodstream infections.
Product
OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477009
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2599-2021·2021-10-06
Stretch Leveller Model 3156200 May Lose Horizontal Position Control
Hill-Rom's Stretch Leveller Model 3156200 may lose the ability to maintain patients in a horizontal position during lifting, potentially causing patients to slide backward or fall from the lift sheet.
Product
Stretch Leveller Model Number: 3156200 - 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-2544-2021·2021-10-06
B. Braun Infusion Pump Sets Recalled for Leakage and Infection Risk
B. Braun Medical's infusion pump sets may leak, potentially delaying medication delivery and causing incomplete dosing. The defect poses a risk of bloodstream infections.
Product
15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2595-2021·2021-10-06
Anesthesia Flow Sensors Recalled for Tube Damage and Potential Gas Leaks
GE Healthcare is recalling approximately 310,000 replacement flow sensors for anesthesia machines manufactured before June 2021. The sensors may have damaged tubes that leak, causing incorrect anesthesia delivery to patients.
Product
Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF BCG, SERVICE (blue, cleanable) 2087640-001 FLOW SENSOR, LEGACY VAR ORF AUTOC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2563-2021·2021-10-06
Radiation therapy planning software can save contours to wrong image set
Elekta Monaco radiation therapy planning software has a defect allowing contour edits to be saved to the wrong image set without freezing the radiation dose for affected treatment plans.
Product
Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
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-2557-2021·2021-10-06
B. Braun Outlook Pump Set 3 Recalled for Leakage and Medication Delivery Delays
B. Braun Medical is recalling 768 units of Outlook Pump Set 3 infusion sets due to potential leakage that could delay or prevent complete medication delivery and increase risk of bloodstream infection.
Product
OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490564
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-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-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-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

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12901–12925 of 13802