State

American Samoa product recalls

72,820 recalls have nationwide distribution and so reach American Samoa. 24 additional recalls listed American Samoa specifically in their distribution scope.

What the numbers show

Total: 24
Critical: 0
Severe: 5
Most recent: 2025-10-22

Of the 24 recalls naming American Samoa we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (21%) are Severe.

Which agencies issued them

These figures cover only the 24 recalls whose distribution notice names American Samoa specifically. The 72,820 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

301–325 of 72844

SevereFDA (Drugs)·D-0744-2026·2026-08-12
Cyclophosphamide Injection Recall: Stainless Steel Particulate Matter Found
Cyclophosphamide for Injection, USP, 2 gram/vial, is being recalled due to the presence of particulate matter identified as stainless steel. The recall affects 1,464 vials distributed nationwide.
Product
Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2891-2026·2026-08-12
Philips Allura X-Ray Systems Recalled Over Unauthorized Hard Disk Drives
Philips is recalling 5,012 Allura interventional fluoroscopic X-ray systems nationwide due to potential loss of imaging functionality, motorized movement, or data caused by unauthorized hard disk drives.
Product
Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper FD10/10; Model Numbers: 722005, 722011, 722027. 4. Allura
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0745-2026·2026-08-12
FDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
Zydus Pharmaceuticals is recalling Mirabegron extended-release tablets, 25 mg, due to an out-of-specification result for the N-Nitroso Mirabegron impurity. The recall affects nationwide distribution in the USA.
Product
MIRABEGRON — MIRABEGRON (MIRABEGRON)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2876-2026·2026-08-12
GE Healthcare MAC VU360 Electrocardiograph Software Recall
GE Healthcare is recalling 163 MAC VU360 electrocardiograph units due to a software issue that may cause a previous patient's data to remain visible and be incorrectly associated with a subsequent patient.
Product
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2862-2026·2026-08-12
Stryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
Stryker is recalling 46,212 units of its AHTO Tube Set Packaging (Catalog Number 0250070600) due to reported complaints of leaking from the handpiece during use. The recall affects products distributed worldwide, including US Nationwide and multiple countries.
Product
STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2850-2026·2026-08-12
Quantum Rehab Q6 Edge 4 Wheelchairs Recalled Due to Controller Software Issue
Pride Mobility Products Corp. is recalling Quantum Rehab Q6 Edge 4 powered wheelchairs because a software issue can cause unexpected braking and potential injury.
Product
Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 Edge 4 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2875-2026·2026-08-12
Merge OrthoPACS Imaging Workstation Recall for Patient Data Display Issue
Merge Healthcare is recalling 5 units of its Merge OrthoPACS medical imaging diagnostic workstation due to a software issue where thumbnails from a previously opened patient study may appear while a different patient study is currently open.
Product
Merge OrthoPACS, medical imaging diagnostic workstation
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2889-2026·2026-08-12
Beckman Coulter MicroScan Panel Update DVD Kits Recalled
Beckman Coulter is recalling MicroScan LabPro V5.03 Panel Update 11 DVD Kits due to incorrect algorithms that may affect antimicrobial susceptibility test results, potentially leading to false susceptibility classifications.
Product
REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan Walk
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·26V526000·2026-08-12
Nissan Recalls 2025 Altima Vehicles Due to Air Bag Fastener Defect
Nissan is recalling 2025 Altima vehicles because incorrect mounting fasteners may prevent front passenger air bags from deploying as intended in a crash.
Product
NISSAN — NISSAN ALTIMA
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2840-2026·2026-08-12
Radial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
Boston Scientific is recalling Radial Jaw 4 Jumbo Biopsy Forceps due to potential breach in the sterile barrier of device packaging. The recall affects 5,020 units in the US and 20,770 units outside the US.
Product
Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2897-2026·2026-08-12
United Orthopedic U2 Knee Implant Bushings Recalled Over Engraving Design Issue
United Orthopedic Corp. is recalling three Femoral offset bushing components of the U2 Total Knee System due to a design issue causing incorrect engraved numbering that could lead to incorrect implant orientation during surgery.
Product
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2909-2026·2026-08-12
Blom-Singer Voice Prosthesis Boxes Mislabeled with Wrong Flange Type
Freudenberg Medical is recalling 12 Blom-Singer Classic Indwelling Voice Prosthesis devices because the boxes are mislabeled, swapping Large Esophageal Flange and Large Esophageal and Tracheal Flange contents.
Product
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2856-2026·2026-08-12
Powered Wheelchair Control Software Recall by munevo
Munevo is recalling 19 powered wheelchair hands-free control systems due to a software issue that may cause the driving mechanism to fall out of calibration, leading to unexpected steering drift or imprecise control.
Product
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2906-2026·2026-08-12
COAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
TISSIUM SA recalls COAPTIUM CONNECT nerve repair devices due to unvalidated 36-month shelf life labeling. Revised 26-month label will be applied. Device breakage beyond validated shelf life may require revision surgery.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2836-2026·2026-08-12
FORWARD Oral Airway Kit Recall for Potential Airway Obstruction
Integrated Medcraft LLC recalls FORWARD Oral Airway Kits due to potential occlusion of the airway tip, which could impede breathing in medical settings.
Product
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2894-2026·2026-08-12
5-PLASMA Bivalirudin AMR Verification Kit Recalled Due to Stability Issues
Aniara Diagnostica LLC recalls its 5-PLASMA Bivalirudin AMR Verification Kit due to stability issues causing degradation of measurable bivalirudin in controls, calibrators, and linearity values. FDA Class II recall.
Product
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2885-2026·2026-08-12
U2 Total Knee System Femoral Valgus Adaptor Recall
United Orthopedic Corp. is recalling its U2 Total Knee System femoral valgus adaptors due to a manufacturing defect that prevents proper assembly of the stem component during surgery.
Product
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2884-2026·2026-08-12
USTAR II Knee System Hinge Box Trial Recall
United Orthopedic Corp. is recalling USTAR II Knee System Hinge Box Trials due to a manufacturing defect that could prevent proper assembly of the stem trial component.
Product
Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2890-2026·2026-08-12
Siemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
Siemens Healthcare Diagnostics is recalling Atellica CH Urine Albumin assays due to potential false results and QC failures when processed on CI analyzers.
Product
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2861-2026·2026-08-12
DASH Rapid PCR Instrument Recalled Due to Software Issue Causing False Co-infection Results
Nuclein LLC is recalling the DASH Rapid PCR Instrument (Model SG-0002) because a software issue may result in false co-infection readings.
Product
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chai
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2911-2026·2026-08-12
Neuroguard IEP Carotid Stent and Balloon System Recalled for Filter Failure Risk
Contego Medical, Inc is recalling Neuroguard IEP Carotid Stent and Post-Dilation Balloon Systems due to a potential filter failure issue.
Product
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2846-2026·2026-08-12
Quantum Rehab Q6 Edge 2.0 Power Wheelchair Recall
Pride Mobility is recalling 1,102 Q6 Edge 2.0 power wheelchairs due to a software issue that may cause unexpected braking or control system crashes during use.
Product
Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2903-2026·2026-08-12
Tissium Peripheral Nerve Repair Device Shelf Life Recall
Tissium SA is recalling the COAPTIUM CONNECT peripheral nerve repair device due to an unsubstantiated 36-month shelf life; devices will be relabeled to a validated 26-month shelf life.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2866-2026·2026-08-12
Stryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
Stryker is recalling Strykeflow Suction/Irrigator PS devices due to reports of leaking from the handpiece during use.
Product
STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2899-2026·2026-08-12
GEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
Instrumentation Laboratory is recalling specific GEM Premier 7000 with iQM3 PAK lots because the lysing bag solution concentration does not meet manufacturing specifications, potentially delaying medical management.
Product
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium h
Category
Medical Device
Distribution
Distributed nationwide