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

7551–7575 of 13652

HighFDA (Devices)·Z-0707-2024·2024-01-17
Cardiac Stress Testing Device May Produce Distorted ECG Readings
The XScribe CP Cardiac Stress Testing System (version 6) is being recalled because it may produce distorted electrocardiogram readings when the Source Consistency Filter is enabled, which could affect the accuracy of cardiac test results.
Product
XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT Q
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0676-2024·2024-01-17
BD Recanalization System May Overheat or Break During Use
Bard Peripheral Vascular is recalling BD Recanalization Systems due to a manufacturing defect that may allow continuous operation without required safety warnings, increasing risk of device overheating or breaking during patient treatment.
Product
BD Recanalization System, REF: BDRECANSYSTEM
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-0711-2024·2024-01-17
Medline Surgical Gowns Recalled for Manufacturing Defect in Sleeves
Medline is recalling 2,100 Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 surgical gowns because they were manufactured with the wrong sleeve. The affected gowns were distributed to healthcare facilities in Maryland, Ohio, Tennessee, Texas, and Wisconsin.
Product
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0644-2024·2024-01-17
Olympus ENDOEYE Videoscope Recalled for Reprocessing Instructions Deviations
Olympus Corporation recalls 1,403 ENDOEYE Flex endoscopic videoscopes due to deviations in reprocessing instructions. Affected devices may not be reprocessed properly for safe reuse in surgical procedures.
Product
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0655-2024·2024-01-17
Abiomed Introducer Kits Recalled for Sterile Barrier Pouch Defect
Abiomed is recalling 84 introducer kits that may have holes in the outer pouch, compromising the sterile barrier. This exposes patients to microbial contamination and risk of serious infections including bacteremia and sepsis.
Product
Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 2000342
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0702-2024·2024-01-17
H. Pylori Diagnostic Test Recalled Due to Incorrect Expiration Date Label
Immunostics is recalling H. Pylori diagnostic test kits due to mislabeled expiration dates. Using the product after expiration may produce false positive, false negative, or invalid results.
Product
Detector H. Pylori, Catalog Number IHP-30
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0677-2024·2024-01-17
Philips BrightView Gamma Camera System Recalled for Extremity Entrapment Hazard
Philips is recalling BrightView Gamma Camera Systems because a gap can form between patient support and detector during quality assurance scans, creating an extremity entrapment hazard that may cause fractures or crush injuries.
Product
BrightView, Gamma Camera System, Product Code 882480.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0681-2024·2024-01-17
Abbott Alinity c Chemistry Analyzer Contains Unlabeled Latex Subcomponent
Abbott Laboratories is recalling 1,127 Alinity c Processing Module chemistry analyzers because unlabeled latex subcomponents are present. Users with latex allergies may experience serious allergic reactions upon contact.
Product
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinit
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-0670-2024·2024-01-17
Townsend Design Custom SPRYSTEP Ankle-Foot Orthosis Recalled for Structural Failure Risk
Townsend Design is recalling 248 units of CUSTOM SPRYSTEP ankle-foot orthotics for potential air pockets that could cause complete structural failure and loss of ankle support.
Product
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-0697-2024·2024-01-17
Olympus ENDOEYE HD II Videoscope Image Discoloration Recall
Two Olympus ENDOEYE HD II Rigid Videoscope catalog numbers (WA50040A, WA50042A) have been recalled due to reports of pink or green image discoloration during use. The issue could require device exchange during surgery and potentially result in visual impacts or bleeding.
Product
Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the tho
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0673-2024·2024-01-17
Boston Scientific ZOOM LATITUDE Pacemaker Programmer Software Displays Incorrect Diagnostic Dates
Boston Scientific is recalling pacemaker programmer software that displays certain diagnostic dates incorrectly, with dates showing years in the 1990s. Affected diagnostic information may impact clinical monitoring.
Product
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0641-2024·2024-01-17
Medical diagnostic reagent recall: incorrect cell staining fluorescence
BD Biosciences is recalling CD11b APC diagnostic reagent vials that may produce dim fluorescence signals, potentially causing false negative results and misdiagnosis of blood cancers.
Product
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0699-2024·2024-01-17
Medtronic Percutaneous Pins Recalled for Potential Fitting and Removal Issues
Medtronic is recalling 4,224 REF 9733236 percutaneous pins due to a manufacturing defect that may prevent proper fitting or cause difficult removal. Affected devices were distributed worldwide.
Product
Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0678-2024·2024-01-17
Gamma Camera Gap Creates Extremity Entrapment Hazard During Quality Assurance
Philips BrightView X gamma cameras may create a gap between patient support and detector during quality assurance scans, potentially trapping a patient's extremity.
Product
BrightView X, Gamma Camera, Product Code 882478
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0660-2024·2024-01-17
Baxter Preveleak Surgical Sealant recall for inaccurate marketing brochure
Baxter Healthcare has recalled a marketing brochure for its Preveleak Surgical Sealant due to inaccurate content that does not align with the product's Instructions for Use. Healthcare providers and consumers should consult the accurate product Instructions for Use and Prescribing Information.
Product
Baxter Preveleak Surgical Sealant, Product Codes: ADS201808
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0652-2024·2024-01-17
Abiomed Introducer Kit Sterile Barrier Compromise Due to Pouch Defect
Abiomed Introducer Kits may have holes in outer pouches that compromise sterility, exposing patients to bacterial contamination and risk of infection, bacteremia, or sepsis.
Product
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3046
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0701-2024·2024-01-17
VADER Pedicle System Torque Wrench Recalled Due to Defective Tightening Function
Icotec is recalling VADER pedicle system torque wrenches because the torque limiting function can malfunction, potentially leaving screw fasteners insufficiently tightened during implant surgery.
Product
VADER pedicle system, torque wrench, Catalog Number 42-703
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-0647-2024·2024-01-17
Abiomed Oscor Introducer Kit Recalled Due to Sterile Barrier Compromise
Abiomed is recalling its Oscor Introducer Kit due to holes in the outer pouch that may compromise the sterile barrier. Non-sterile introducers could expose patients to infection, bacteremia, or sepsis.
Product
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0700-2024·2024-01-17
VADER pedicle system torque wrench may not tighten implant screws correctly
Icotec Ag is recalling VADER pedicle system torque wrenches (Catalog Number 42-702) because the torque limiting function may malfunction, potentially leaving nut screws insufficiently tightened during implant surgery. No injuries have been reported.
Product
VADER pedicle system, torque wrench, Catalog Number 42-702
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-0680-2024·2024-01-17
Abbott Alinity i Processing Module Recalled for Unlabeled Latex Subcomponent
Abbott Laboratories is recalling 1,325 Alinity i Processing Module systems due to unlabeled dry natural rubber (latex) subcomponents. Users with latex allergies may be at risk of exposure.
Product
Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology.
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-0713-2024·2024-01-17
Wheelchair Control Device Throttle Lever May Stick During Operation
The Scoot Control R-net wheelchair attendant controller's throttle lever may stick and fail to return to neutral, potentially causing unwanted chair movement. A total of 129 units were distributed in Tennessee and Texas.
Product
Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0706-2024·2024-01-17
XScribe Cardiac Stress Testing System may distort ECG readings
Baxter Healthcare Corporation is recalling 2,985 units of the XScribe Cardiac Stress Testing System, version 6, due to potential distortion in electrocardiogram readings when the Source Consistency Filter is enabled. No injuries have been reported.
Product
XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX; c) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX; d) XS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ; e) XS6
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0698-2024·2024-01-17
Medtronic Percutaneous Surgical Pins Recalled Due to Potential Fitting Defects
Medtronic is recalling 4,235 percutaneous surgical pins that may have a manufacturing defect preventing proper fit into or removal from the tap cap. The pins were distributed nationwide and internationally.
Product
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0703-2024·2024-01-17
Diagnostic Test Kits for GI Panel May Return False Negatives Due to Manufacturing Issue
BioFire FILMARRAY GI Panel diagnostic test kits may return false negative results due to a manufacturing event, potentially leading to missed diagnoses and inappropriate treatment. The affected kits were distributed to locations in 16 U.S. states.
Product
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0653-2024·2024-01-17
Oscor Intro Catheter Introducer Kit: Compromised Sterile Barrier
Abiomed is recalling Oscor Intro Introducer Kits due to holes in the outer pouch that may compromise the sterile barrier, potentially exposing patients to harmful bacteria and infections including bacteremia and sepsis.
Product
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025
Category
Medical Device
Distribution
Distributed nationwide

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