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

24326–24350 of 26082

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-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-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-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-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-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-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-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-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-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-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-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 (Food)·F-1018-2021·2021-10-06
Enrico Biscotti Cranberry Pistachio Biscotti recalled for undeclared soy
The Enrico Biscotti Company is recalling Enrico Biscotti Cranberry Pistachio Biscotti because the product contains undeclared soy, which poses a risk to consumers with soy allergies.
Product
Enrico Biscotti - Cranberry Pistachio Biscotti 8 ounce bags 6 bags per case
Category
Food
Distribution
0 states
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-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
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-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-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 (Food)·F-1019-2021·2021-10-06
Enrico Biscotti Anise Almond Biscotti Recalled for Undeclared Soy
The Enrico Biscotti Company is recalling Enrico Biscotti Anise Almond Biscotti 8-ounce bags because they contain undeclared soy, a major allergen. The recall affects 3,840 bags distributed to Ohio and New York.
Product
Enrico Biscotti - Anise Almond Biscotti 8 ounce bags 6 bags per case
Category
Food
Distribution
0 states
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-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-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-2591-2021·2021-10-06
MOSAIQ Oncology Information System software defect reverts approved drug strength
The MOSAIQ Oncology Information System has a software defect where approved changes to drug strength revert to the original value when saved, potentially resulting in incorrect medication dosages.
Product
MOSAIQ Oncology Information System
Category
Medical Device
Distribution
17 states

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24326–24350 of 26082