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

5201–5225 of 13512

ModerateFDA (Devices)·Z-3079-2024·2024-09-18
FDA Recalls Syringe Tip Caps Due to Unapproved Device Modifications
Sol-Millennium Medical Inc. is recalling certain Syringe Tip Cap models because they were modified without proper FDA clearance. The modified devices differ from their approved specifications.
Product
Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3112-2024·2024-09-18
Medline Suction Liners Recalled Due to Potential Loss of Suction
Medline is recalling 1,616 units of semi-rigid suction liners (ENDO KIT, pack numbers DYKE1350D and DYKE1514B) manufactured September to November 2023 that may lose or provide reduced suction during use.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYKE1514B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3103-2024·2024-09-18
Diagnostic test shows measurement bias at critical threshold
Siemens Healthcare Diagnostics is recalling ADVIA Centaur CA 19-9 test kits due to positive bias in measurements around the critical threshold of 35 U/mL, affecting diagnostic accuracy.
Product
ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491379 SMN: 11206239
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2943-2024·2024-09-11
Trilogy Evo Ventilator Software Update for Identified Safety Issues
Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for the Trilogy Evo Universal Ventilator to address safety issues identified in earlier recalls. Affected units should implement the update.
Product
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2942-2024·2024-09-11
Trilogy Evo EV300 Ventilator Mandatory Software Update for Safety Issues
Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for Trilogy Evo EV300 ventilators to resolve previously identified safety issues. Approximately 90,910 US units and 56,273 international units are affected.
Product
Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2721-2024·2024-09-11
Fresenius Kabi IV Administration Sets Recalled for Uncontrolled Medication Flow Risk
Fresenius Kabi is recalling LVP Primary Administration Sets due to a defect that may cause uncontrolled medication flow and potential overdose. The recall affects 4,500 pieces distributed in Colorado, Idaho, New Jersey, and Utah.
Product
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-2690-2024·2024-09-11
Vivo 45 LS Ventilator Recall: Potential Formaldehyde Emission Risk
Breas Medical is recalling the Vivo 45 LS ventilator due to potential elevated formaldehyde emissions into the patient breathing airpath under specific conditions.
Product
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2944-2024·2024-09-11
Philips Respironics Trilogy Evo Ventilator Software Update Addresses Safety Issues
Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for Trilogy Evo ventilators worldwide to resolve identified safety issues. Users must apply the update and review the updated User Manual.
Product
Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2, US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2965-2024·2024-09-11
Impella 5.5 Device Recalled for Missing Labeling on Catheter Interaction
Abiomed is updating labeling for Impella 5.5 cardiac support pumps to include information about a potential device interaction with Shockwave Coronary IVL Catheters during coronary interventions.
Product
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2979-2024·2024-09-11
Power Express PE Centrifuge adhesive joint failure may cause component detachment
The adhesive joint in this medical device component can fail, causing the metal part to detach. This may damage the centrifuge, destroy patient samples, and potentially expose lab staff to biohazardous material.
Product
PE Centrifuge, REF: B36365, a component of the Power Express
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2980-2024·2024-09-11
Beckman Power Express Centrifuge Sample Holder May Detach During Operation
An adhesive joint failure in the PE Centrifuge Temperature Controlled component can cause the metal part to detach inside the centrifuge, risking sample destruction and potential exposure of laboratory technicians to biohazardous material.
Product
PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2945-2024·2024-09-11
Heparin Gore Viabahn VBX Endoprosthesis Recalled for Packaging Defects
W L Gore & Associates is recalling Heparin Gore Viabahn VBX Balloon Expandable Endoprosthesis devices due to packaging defects that may compromise sterility assurance and heparin activity.
Product
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2970-2024·2024-09-11
Impella 5.5 SmartAssist S2 Labeling Updated for Shockwave Catheter Interaction
Abiomed is updating labeling for the Impella 5.5 SmartAssist S2 cardiac assist device to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions.
Product
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2950-2024·2024-09-11
Anesthesia Vaporizer Adapter May Deliver Excessive Anesthetic Concentration
Sevoflurane vaporizer adapters used with Mindray A9 anesthesia systems may deliver higher-than-set anesthetic concentrations due to incomplete sealing. Patients could inhale excessive anesthetic, potentially causing drowsiness, vertigo, or in severe cases, neurological effects.
Product
Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: 115-066756-00
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2948-2024·2024-09-11
BD Pyxis QFill Medication Cabinet Software Bug Causes Incorrect Restock Labels
The BD Pyxis QFill Replenishment Station medication cabinet has a software issue that may print incorrect bin information on restock labels for medications stored in non-CUBIE locations.
Product
BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2955-2024·2024-09-11
Impella CP Smart Assist Set Lacks Labeling for Potential Device Interaction
Abiomed is updating labeling for the Impella CP Smart Assist Set to warn about a potential interaction with the Shockwave Coronary IVL Catheter when used during coronary interventions. The interaction was previously undocumented in the device instructions.
Product
Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2966-2024·2024-09-11
Impella 5.5 Pump Labeling Updated Due to Device Interaction
Abiomed updated Impella 5.5 cardiac pump labeling to document a potential interaction with Shockwave Coronary IVL Catheter during coronary procedures. No injuries have been reported.
Product
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2964-2024·2024-09-11
Pump 381 Pump Set lacks labeling for Shockwave catheter interaction risk
Abiomed's Pump 381 Pump Set labeling lacks information about potential interactions with Shockwave Coronary IVL Catheters during coronary interventions. The manufacturer is updating instructions for use to address this gap.
Product
Pump 381 Pump Set (US); Product Code: 1000080;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2958-2024·2024-09-11
Impella CP Smart Assist Set device interaction with coronary catheters
The FDA is recalling Impella CP Smart Assist Sets due to a potential device interaction with Shockwave Coronary IVL Catheters used during coronary interventions. Abiomed will update device labeling to inform users about this interaction.
Product
Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2956-2024·2024-09-11
Impella CP Pump Set Recalled for Potential Device Interaction
Abiomed is recalling the Impella CP Pump Set due to a potential device interaction with the Shockwave Coronary IVL Catheter during coronary interventions. The manufacturer will update device instructions to address this interaction.
Product
Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2951-2024·2024-09-11
Anesthesia System Vaporizer Adapter Recalled for Potential Anesthetic Overdose
Mindray's Isoflurane E_Vap adapter for the A9 Anesthesia System is recalled due to a seal defect that may cause higher-than-intended anesthetic concentration delivery. Twenty-four units were distributed to eight U.S. states and Canada.
Product
Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number 115-066758-00
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2978-2024·2024-09-11
Medical Device Sample Holder Recalled for Adhesive Joint Failure
Beckman Coulter Power Express sample holders can fail at the adhesive joint between plastic socket and metal component. This may cause the metal part to detach inside the centrifuge, potentially damaging equipment and exposing lab staff to biohazardous material.
Product
Power Express, REF B90918
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1546-2024·2024-09-11
Beckman Coulter DxI 9000 Analyzer Recalled for Leaking Wash Buffer Tank
Beckman Coulter is recalling 17 DxI 9000 Access Immunoassay Analyzers due to cracks in the Internal Wash Buffer Tank that can cause leaking, potentially delaying test results and exposing users to chemical and physical hazards.
Product
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2947-2024·2024-09-11
BD Pyxis QFill Medication Cabinet Software Issue Causes Incorrect Bin Labeling
A software bug in BD Pyxis QFill medication cabinet systems may print incorrect medication bin labels during restocking, potentially causing medication errors. Three units are affected.
Product
BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2952-2024·2024-09-11
Desflurane anesthesia vaporizer recalled for possible excessive anesthetic output
Mindray's Desflurane E_Vap vaporizer may deliver anesthetic at higher concentrations than set due to an incomplete seal. Patients could inhale excessive anesthetic, potentially causing dizziness, drowsiness, and in severe cases, neurological effects.
Product
Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number115-066759-00
Category
Medical Device
Distribution
0 states

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5201–5225 of 13512