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

7976–8000 of 13652

SevereFDA (Devices)·Z-0192-2024·2023-11-15
Olympus Bronchovideoscopes Recalled for Endobronchial Combustion Risk
Olympus is recalling bronchovideoscopes nationwide due to a risk of combustion inside the bronchial passages during high-frequency cauterization if oxygen is supplied or the electrode is positioned too close to the scope's tip.
Product
EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0189-2024·2023-11-15
Five Olympus Bronchovideoscope Models Recalled for Endobronchial Combustion Risk
Olympus is recalling 15,942 bronchovideoscope units nationwide due to endobronchial combustion risk during cauterization procedures with oxygen supply. The hazard occurs when the electrode of the surgical accessory is positioned too close to the scope's distal end.
Product
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0151-2024·2023-11-15
Novum IQ Syringe Pump may falsely indicate infusion completion
Baxter's Novum IQ Syringe infusion system may display a false 'Infusion Complete' alarm after multiple occlusion events, leaving uninfused fluid in the syringe and risking incomplete medication delivery.
Product
Novum IQ Syringe infusion system, Product Code 40800BAXUS
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0190-2024·2023-11-15
Olympus Bronchovideoscope Recall for Combustion Risk with Electrosurgery
Olympus is recalling 1,154 EVIS EXERA II bronchovideoscope units due to risk of endobronchial combustion during high-frequency electrosurgical procedures when oxygen is supplied and electrode placement is inappropriate.
Product
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0194-2024·2023-11-15
FDA Recalls Olympus EVIS EXERA III Bronchovideoscope for Combustion Risk
Olympus Corporation is recalling 3,948 EVIS EXERA III bronchovideoscope units nationwide due to risk of combustion during electrosurgical procedures when high-frequency cauterization is used with oxygen supply.
Product
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0188-2024·2023-11-15
StealthStation S8 Surgical Navigation System Software Anomaly Recall
Medtronic is recalling StealthStation S8 and FlexENT systems with software versions 2.0 and 2.0.1 due to a software anomaly that could cause surgical planning data to shift to an unintended location.
Product
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0186-2024·2023-11-15
Alaris PCA Module 8120 Infusion Pump Syringes Labeling Contains Unvalidated Products
CareFusion is recalling the Alaris PCA Module 8120 infusion pump because its labeling lists compatible syringes that have not been validated for use with the device.
Product
Alaris PCA Module 8120
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0249-2024·2023-11-15
Stryker Bipolar Forceps Recalled for Incorrect Expiration-Date Labeling
Stryker Corporation is recalling 2,321 Disposable Spetzler-Malis Bipolar forceps due to incorrect shelf-life labeling. Products labeled with 54-month shelf life actually have a 36-month shelf life.
Product
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0134-2024·2023-11-15
Allergan Universal Fill Kit for tissue expanders recalled due to leakage risk
B. Braun Medical is recalling Allergan Universal Fill Kits for tissue expanders due to a manufacturing defect that may cause device leakage. Leakage can delay treatment, increase infection risk, and potentially create life-threatening situations.
Product
ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0255-2024·2023-11-15
Stryker Disposable Bipolar Forceps Recall for Incorrect Expiration Date Labeling
Stryker Corporation recalls Disposable Spetzler-Malis Bipolar forceps due to labeling error. Products are labeled for 54-month shelf life but have actual 36-month shelf life, risking use of expired sterile surgical equipment.
Product
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0222-2024·2023-11-15
Patient Alarm Pendant with Wristband Recalled for Premature Battery Depletion
Securitas Healthcare is recalling its Arial Water Resistant Pendant (Models 59362 and 2560-59362) due to premature battery depletion, which may prevent alarms from being received by the emergency call system.
Product
Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile patient alarm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0289-2024·2023-11-15
DRX-Revolution Mobile X-Ray System Generator May Overheat Unexpectedly
Carestream Health is recalling 2,402 DRX-Revolution Mobile X-Ray Systems due to potential electrical failure in the generator causing thermal overload. The system becomes inoperable and may produce loud noise, burnt smell, and smoke.
Product
The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of st
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0276-2024·2023-11-15
DigitalDiagnost C90 radiographic system poses ceiling-mount failure risk
Philips DigitalDiagnost C90 ceiling-mounted radiographic systems may fail and fall. FDA Class II recall affects 143 units nationwide; facilities should contact Philips.
Product
DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0131-2024·2023-11-15
Burette Assembly Recalled for Manufacturing Defect Causing Potential Leakage
B. Braun recalls 30 ML 2PORT burette assemblies (lot 0061766049) for potential leakage due to manufacturing defect. Leakage risks delayed therapy, bloodstream infection, and medication exposure to patients and healthcare workers.
Product
30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0251-2024·2023-11-15
Disposable Bipolar Forceps Recalled for Incorrect Expiration Date Labeling
Stryker Corporation is recalling certain Spetzler-Malis Bipolar forceps due to incorrect expiration dates on product labels. The labels indicate a 54-month shelf life, but the actual shelf life is 36 months.
Product
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-010
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0130-2024·2023-11-15
B. Braun AMO Administration Set Recalled for Manufacturing Defect Causing Leakage
B. Braun Medical is recalling AMO ophthalmologic administration sets due to a manufacturing defect causing potential leakage. This may delay therapy and expose patients and healthcare workers to hazardous medication.
Product
AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0220-2024·2023-11-15
Arial Water Resistant Pendant Alarm Recalled for Battery Depletion Risk
Securitas Healthcare is recalling Arial Water Resistant Pendants (models 59360 and 2560-59360) due to premature battery depletion that may prevent emergency alarms from being received.
Product
Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0287-2024·2023-11-15
Stryker Portal Entry Kit Recalled Due to Expired Product Distribution
Stryker Corporation recalled 19 Portal Entry Kits distributed to surgical facilities in multiple U.S. states due to expired product. The kits aid surgeons in establishing arthroscopic portals.
Product
Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access.
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0239-2024·2023-11-15
Disposable Spetzler-Malis Bipolar Forceps Recalled for Incorrect Shelf Life Label
Stryker is recalling 2,321 disposable Spetzler-Malis Bipolar forceps due to a labeling error showing an incorrect shelf life. The product label indicates 54 months, but the actual shelf life is 36 months.
Product
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0247-2024·2023-11-15
Stryker Disposable Bipolar Forceps Recalled for Expiration Date Labeling Error
Stryker Corporation is recalling 2,321 units of disposable bipolar forceps due to a labeling error. The product label shows a 54-month shelf life, but the actual shelf life is 36 months.
Product
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-180-015
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0135-2024·2023-11-15
Burette Assembly With Stopcock Recalled Due to Manufacturing Defect and Leakage Risk
B. Braun Medical is recalling 400 units of a 30ML burette assembly due to a manufacturing defect that may cause leakage, potentially delaying therapy and increasing bloodstream infection risk.
Product
30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0254-2024·2023-11-15
Stryker Disposable Bipolar Forceps Recalled for Incorrect Expiration Date Labeling
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to an expiration date labeling error. The label incorrectly shows a 54-month shelf life when the actual shelf life is 36 months.
Product
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-015
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0275-2024·2023-11-15
Philips DigitalDiagnost C90 Radiographic Systems Recalled for Ceiling Mount Failure
Philips is recalling 33 DigitalDiagnost C90 radiographic imaging systems nationwide due to potential structural failure of ceiling-mounted units. Equipment may fall, creating injury risk.
Product
DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0238-2024·2023-11-15
Fogarty Thru-Lumen Embolectomy Catheter Recalled for Delayed Balloon Deflation
Edwards Lifesciences is recalling Fogarty Thru-Lumen Embolectomy Catheters that may deflate more slowly than normal, potentially affecting device function during vascular procedures.
Product
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0260-2024·2023-11-15
Surgical Procedure Pack Contains Latex Despite 'Latex-Free' Label
Alcon Custom-Pak surgical procedure packs contain latex gloves but are labeled as 'latex-free,' posing an allergic reaction risk for healthcare workers and patients with latex allergies.
Product
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Category
Medical Device
Distribution
1 state

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7976–8000 of 13652