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

8801–8825 of 40056

HighFDA (Devices)·Z-0317-2024·2023-11-22
Oasis Water Seal Chest Drains Recalled for Inadequate Setup Instructions
Atrium Medical's Oasis Dry Suction Water Seal Chest Drains are recalled because Instructions for Use do not adequately explain proper setup of catheter and patient tube connections on single collection chamber models.
Product
Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0319-2024·2023-11-22
CT Scanner Software Bug May Cause Gantry to Move to Wrong Position
Philips Spectral CT on Rails software version 5.1.0 may fail to move the needle position to the desired location during scans. This could cause the gantry to move unexpectedly and potentially collide with the user or needle.
Product
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0300-2024·2023-11-22
LIFEPAK 15 Defibrillator Recall: Loose Battery Pins Risk Power Loss
Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, causing power issues.
Product
LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0310-2024·2023-11-22
Medline Blood Culture Collection Kits Recalled for Expired Internal Components
Medline is recalling 4,850 adult blood culture collection kits (lot numbers 23EMI373, 23EMF712, 23DMF155, 23CMH026) because components inside expired before the kit's labeled expiration date.
Product
ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0306-2024·2023-11-22
Philips Spectral CT on Rails Software Crash During Fluoroscopy Operations
Philips is recalling the Spectral CT on Rails (Model 728334, Software Version 5.1.0) due to a software crash that occurs when CCT Fluoroscopy mode and foot pedal are activated simultaneously. The crash requires system restart.
Product
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0309-2024·2023-11-22
Medical Device Reagent Recalled for Unreliable Test Results
Beckman Coulter's Transferrin reagent lot 2573 does not maintain stability as claimed, causing unreliable patient test results and control failures. The company confirmed the issue affects diagnostic accuracy.
Product
AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0312-2024·2023-11-22
Medline Recalls Central Line Blood Culture Kits Over Expired Components
Medline Industries is recalling 1,600 Central Line Blood Culture kits due to component expiration prior to the listed kit expiration date. Expired materials could compromise blood culture test accuracy.
Product
CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0223-2024·2023-11-22
Siemens Mobilett Mira wireless x-ray systems recalled for buzzer mounting defect
Four Siemens Mobilett Mira wireless mobile x-ray systems are recalled due to incorrect buzzer component mounting that prevents acoustic signals during x-ray activation. The systems remain fully functional with visual LED indicators available for operator monitoring.
Product
Mobilett Mira wireless (VA20) mobile x-ray system(s)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0184-2024·2023-11-15
Alaris PCA Module 8120 infusion pump recalled for unvalidated syringes
CareFusion 303, Inc. is recalling the Alaris PCA Module 8120 infusion pump because its labeling lists compatible syringes that have not been validated. This Class I recall affects 867,362 units worldwide.
Product
BD Alaris PCU REF 8015
Category
Medical Device
Distribution
Distributed nationwide
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-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-0191-2024·2023-11-15
Olympus Bronchovideoscope Recalled for Fire Risk During Cauterization
Olympus Corporation recalls 13,950 EVIS EXERA II bronchovideoscopes due to risk of endobronchial combustion when high-frequency cauterization is performed with oxygen supplied while the electrode is positioned too close to the endoscope.
Product
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
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-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
SevereFDA (Devices)·Z-0193-2024·2023-11-15
Olympus Bronchovideoscope Recalled Due to Combustion Risk
Olympus is recalling 719 EVIS EXERA b Bronchovideoscope Model BF-XT190 devices due to risk of endobronchial combustion during high-frequency cauterization when oxygen is supplied or the electrode is too close to the device tip.
Product
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0286-2024·2023-11-15
Cordis Cardiac Catheter Sets Distributed Non-Sterile, Labeled Sterile
Cordis US Corp is recalling cardiac catheter sets (Lot 18223410) distributed in Oklahoma. The devices were non-sterile but labeled as sterile, creating infection risk to patients.
Product
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Category
Medical Device
Distribution
1 state
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-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
HighFDA (Devices)·Z-0240-2024·2023-11-15
Stryker Surgical Forceps Recalled for Incorrect Expiration Date Label
Stryker Corporation is recalling 2,321 units of disposable surgical forceps due to a labeling error. The label indicates a 54-month shelf life, but the products actually expire in 36 months.
Product
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-180-015
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0264-2024·2023-11-15
Family Dollar Pregnancy Test Recalled Due to Improper Storage Conditions
Family Dollar is recalling 329,044 VERIQUICK pregnancy tests due to improper storage outside labeled temperature requirements. Affected units were sold at Family Dollar stores June-October 2023.
Product
VERIQUICK PREGNANCY TEST 1CT, SKU 901260
Category
Medical Device
Distribution
23 states
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-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-0236-2024·2023-11-15
Laboratory Lipase Test Slides Recalled for Measurement Bias Risk
Ortho-Clinical Diagnostics is recalling VITROS Lipase Slides due to measurement abnormalities that could result in falsely low or elevated test results. This could delay diagnosis of acute pancreatitis or cause diagnostic confusion.
Product
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
Category
Medical Device
Distribution
12 states

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8801–8825 of 40056