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

8001–8025 of 13652

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
HighFDA (Devices)·Z-0218-2024·2023-11-15
CardioMEMS Patient Electronic System power connector damage risk
St. Jude Medical is recalling CardioMEMS Patient Electronic System (Model CM1100) because the power connector plug may become damaged and frayed if bent beyond 90 degrees. This could cause device malfunction or electrical hazard.
Product
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0290-2024·2023-11-15
Medical device blood oxygenation system recalled due to defective weld
Maquet Medical Systems USA is recalling 1,022 Cardiohelp-i blood oxygenation systems due to an insufficient weld on a critical component that may break under manual force.
Product
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0283-2024·2023-11-15
Philips EPIQ Diagnostic Ultrasound Systems May Display Delayed Images
Philips is recalling 83 EPIQ diagnostic ultrasound systems that may display delayed instead of real-time images due to a software issue, potentially affecting diagnostic imaging quality.
Product
Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-0281-2024·2023-11-15
RSP Humeral Socket Inserts Swapped During Packaging by Encore Medical
Two different RSP humeral socket insert devices were swapped during packaging at Encore Medical. This could result in surgeons receiving an incorrect device for shoulder surgery, potentially delaying the procedure.
Product
RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Category
Medical Device
Distribution
13 states
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-0277-2024·2023-11-15
Radiographic Imaging System Recall Due to Ceiling Mount Failure Risk
Philips DigitalDiagnost C90 Release 3 ceiling-mounted imaging system faces potential suspension failure risk. The FDA issued a Class II recall for nationwide-distributed Model 712025 due to risk of equipment falling.
Product
DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.
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-0244-2024·2023-11-15
Stryker Disposable Bipolar Forceps Recalled for Overstated Shelf Life
Stryker Corporation recalls 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to incorrect expiration dates on product labels. The actual shelf life is 36 months, but labels indicate 54 months.
Product
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015
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-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-0271-2024·2023-11-15
Philips CombiDiagnost R90 radiography systems recalled for ceiling mount failure
Philips is recalling 46 CombiDiagnost R90 radiography systems nationwide due to potential ceiling mount failure that could allow suspended units to fall, posing an injury risk.
Product
CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
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-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-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-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-0278-2024·2023-11-15
Philips DigitalDiagnost C90 radiography system ceiling-mount failure risk
Philips is recalling two units of its DigitalDiagnost C90 Release 3.1 radiographic imaging system due to potential failure of ceiling-mounted units, which could fall.
Product
DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0261-2024·2023-11-15
Pregnancy Test Kits Recalled Due to Improper Storage Conditions
Family Dollar Stores is recalling 329,044 CLEARBLUE pregnancy test kits that were stored outside labeled temperature requirements from June to October 2023 at stores in 22 states.
Product
CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0224-2024·2023-11-15
Philips surgical imaging systems missing warning label and safety spacer
Philips has recalled certain surgical C-arm imaging systems delivered to Puerto Rico because they lack required warning labels and are missing a critical Source-to-Skin Distance Spacer component.
Product
BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0258-2024·2023-11-15
DJO EMPOWR Knee Punch Handle Tip May Break During Surgery
Encore Medical is recalling DJO EMPOWR Knee Punch Handles due to a manufacturing defect that may cause the handle tip to break during surgery, potentially disrupting the procedure.
Product
DJO EMPOWR Knee Punch Handle, REF: 801-05-040
Category
Medical Device
Distribution
24 states
HighFDA (Devices)·Z-0136-2024·2023-11-15
IV Fitting Components Recalled Due to Manufacturing Defect and Leakage Risk
B. Braun Medical is recalling 175,000 units of bulk largebore male LL fittings due to a manufacturing defect that may cause leakage, potentially increasing bloodstream infection risk.
Product
BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0133-2024·2023-11-15
Medical administration set for radiation therapy recalled due to leakage risk
B. Braun Medical recalls THERASPHERE ADMIN SET due to manufacturing defects causing potential leakage. Leakage may delay therapy, increase bloodstream infection risk, and expose patients and healthcare workers to hazardous medication.
Product
THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0128-2024·2023-11-15
B. Braun FT1000S Fluid Transfer Sets may leak, risking infection
B. Braun is recalling FT1000S Fluid Transfer Sets due to a manufacturing defect that may cause leakage. This could delay therapy, increase infection risk, and expose healthcare workers to hazardous medication.
Product
FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0132-2024·2023-11-15
IV Injection Set Recall: Risk of Leakage and Bloodstream Infection
B. Braun Medical is recalling 12,800 units of TERUMO IV injection sets (Lot 0061753485) due to a manufacturing defect that may cause leakage, delaying therapy and increasing risk of bloodstream infection.
Product
TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0185-2024·2023-11-15
BD Alaris Syringe Module includes non-validated compatible syringes in labeling
CareFusion is recalling 133,727 units of the BD Alaris Syringe Module because the labeling lists compatible syringes that have not been validated for use with the infusion pump.
Product
BD Alaris Syringe Module, REF 8110
Category
Medical Device
Distribution
Distributed nationwide

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8001–8025 of 13652