State

American Samoa product recalls

72,986 recalls have nationwide distribution and so reach American Samoa. 25 additional recalls listed American Samoa specifically in their distribution scope.

What the numbers show

Total: 25
Critical: 1
Severe: 5
Most recent: 2026-09-09

Of the 25 recalls naming American Samoa we have scored against our rubric, 1 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (20%) are Severe.

Which agencies issued them

These figures cover only the 25 recalls whose distribution notice names American Samoa specifically. The 72,986 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8326–8350 of 73011

HighFDA (Devices)·Z-0644-2025·2024-12-11
MEDLINE circumcision kits recalled due to defective smoke evacuation component
MEDLINE is recalling circumcision kits manufactured with SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker. No injuries have been reported.
Product
MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; 3) PACK,CIRCUMCISION ASC, REF DYNJ906909A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0076-2025·2024-12-11
Levothyroxine Sodium Tablets Recalled Due to Subpotency Nationwide
Accord Healthcare is recalling Levothyroxine Sodium 75 mcg tablets (Lot D2300191, expiring 12/31/2025) distributed nationwide due to subpotency. Affected patients should contact their healthcare provider.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0584-2025·2024-12-11
BD EpiCenter Medical Device Software Service Credentials Accessed by Unauthorized Party
BD EpiCenter software service credentials were accessed by an unauthorized actor. Until credentials are updated, there is risk of unauthorized access to the software and associated data.
Product
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0593-2025·2024-12-11
BD BACTEC FX Instrument Top credential compromise enables unauthorized access risk
BD service credentials for BACTEC FX instruments were accessed by an unauthorized actor, creating risk of unauthorized system access until credentials are updated.
Product
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0089-2025·2024-12-11
Array Liquid Antiseptic Handwash Recalled for Microbiological Test Failures
Midlab Incorporated is recalling Array Liquid Antiseptic Handwash due to manufacturing quality deviations. The product failed microbiological testing and may not provide adequate antimicrobial protection.
Product
Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0599-2025·2024-12-11
Atellica CH β2-Microglobulin Reagent Produces Falsely Depressed Results
Siemens Atellica CH β2-Microglobulin reagent may produce falsely depressed test results for samples between 18-30 mg/L, potentially leading to missed or delayed kidney disease diagnoses. No illnesses have been reported.
Product
Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0620-2025·2024-12-11
Olympus Removes Acecide-C Disinfection from GIF-1TH190 Endoscope Reprocessing
Olympus has removed high-level disinfection with Acecide-C as an approved reprocessing method for the GIF-1TH190 gastrointestinal videoscope. Approximately 1,770 units nationwide are affected.
Product
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0098-2025·2024-12-11
Diltiazem Hydrochloride Capsules Recalled Due to Nitrosamine Impurity
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride capsules because they contain a chemical impurity above safe limits. About 7,296 bottles were distributed nationwide.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0596-2025·2024-12-11
Medical Device Breach: BACTEC 9240 System Faces Unauthorized Access Risk
Becton Dickinson recalled the BACTEC 9240 System after unauthorized actors accessed product service credentials. Until credentials are updated, there is risk of unauthorized access that may compromise system security and data integrity.
Product
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0079-2025·2024-12-11
Cinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding FDA Safety Limit
Aurobindo Pharma USA recalls Cinacalcet 90 mg tablets nationwide due to N-nitroso impurity exceeding FDA's interim safety limit. The impurity is a known carcinogenic compound.
Product
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 658
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0585-2025·2024-12-11
BD EpiCenter Data Management System Credential Compromise Poses Unauthorized Access Risk
Service credentials for the BD EpiCenter Data Management System were accessed by an unauthorized actor. Until credentials are updated, system data and access controls are at risk.
Product
BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0524-2025·2024-12-11
Fusion Pro 24 Laser Safety Interlock Fails, Allowing Dangerous Radiation Exposure
Epilog Laser Corp. is recalling Fusion Pro 24 Model 17000 laser systems because an incorrectly placed interlock device allows the front-loading door to open during operation, potentially exposing users to Class 4 laser radiation.
Product
Fusion Pro 24, Model 17000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0630-2025·2024-12-11
Medline Surgical Kits Recalled Due to Defective Smoke Evacuation Component
Medline is recalling 167,074 surgical convenience kits nationwide containing SafeAir Smoke Evacuation Pencils previously recalled by manufacturer Stryker for use in various surgical procedures.
Product
MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS760057L; 4) MAJOR LAPAROTOMY CDS, REF CDS860015W; 5) MINOR LAPAROTOMY CDS, REF CDS860016P; 6) MINOR LAPAROTOMY CDS, REF CDS860016Q; 7) MINOR LAPAROTOMY CDS, REF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0631-2025·2024-12-11
Medline Convenience Kits Recalled Due to Defective Component
Medline Industries is recalling 70 convenience kits containing SafeAir Smoke Evacuation Pencil components that were subsequently recalled by Stryker. The affected product types are General Endoscopy Pack and Endo Bladder Pack.
Product
MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO BLADDER PACK, REF DYNJ49672L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0628-2025·2024-12-11
MEDLINE dental and oral surgery kits recalled due to defective component
MEDLINE is recalling four types of dental and oral surgery convenience kits that were manufactured using SafeAir Smoke Evacuation Pencils, which were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ80226A; 4) DENTAL MINOR PACK, REF DYNJ83140
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0622-2025·2024-12-11
Medline Tracheostomy Convenience Kits Recalled Due to Defective Component
Medline is recalling 88 units of tracheostomy convenience kits containing a defective smoke evacuation pencil component that was previously recalled by Stryker. Products were distributed nationwide.
Product
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0094-2025·2024-12-11
Diltiazem Hydrochloride Capsules Recalled Due to N-Nitroso Impurity Above Limits
Glenmark Pharmaceuticals recalls Diltiazem Hydrochloride extended-release capsules due to presence of N-nitroso-desmethyl-diltiazem impurity above FDA recommended limits. The recall affects 12,864 bottles distributed nationwide.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0638-2025·2024-12-11
MEDLINE medical convenience kits recalled for defective component
Medline is recalling medical convenience kits (CLEAN CLOSING PACK and CLEAN CLOSURE PACK GREEN) distributed nationwide because they contain a SafeAir Smoke Evacuation Pencil component that was recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84667
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0629-2025·2024-12-11
MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Pencil Component
MEDLINE is recalling 102 varieties of surgical convenience kits containing SafeAir Smoke Evacuation Pencils that have been recalled by manufacturer Stryker. The nationwide recall affects 24,754 units.
Product
MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T & A,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0112-2025·2024-12-11
Prescription Drug Lisdexamfetamine Dimesylate Recalled for Failed Content Uniformity
Lannett Company is recalling 1,608 bottles of Lisdexamfetamine Dimesylate 10 mg capsules nationwide due to failed content uniformity. The active ingredient may be unevenly distributed in some capsules.
Product
LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0632-2025·2024-12-11
MEDLINE Port Insertion Pack Recalled for Defective Component
Medline is recalling 44 PORT INSERTION PACK kits nationwide. These kits contain SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0105-2025·2024-12-11
Duloxetine Delayed-Release Capsules Nationwide Recall for N-Nitroso Impurity
Rising Pharma recalls Duloxetine Delayed-Release Capsules 20 mg nationwide due to N-nitroso-duloxetine impurity exceeding recommended interim limits, affecting 209,376 bottles.
Product
Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0096-2025·2024-12-11
Prescription Drug Diltiazem Hydrochloride Recalled for Manufacturing Impurity
Glenmark Pharmaceuticals is recalling 5,232 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to an impurity that exceeds FDA safety limits. Patients currently taking this medication should contact their pharmacist or doctor.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0621-2025·2024-12-11
BD Bacterial Susceptibility Test Discs Recall for Decreased Potency
Becton Dickinson recalled BD BBL Sensi Disc Ampicillin 2 μg test discs due to 65% potency loss over 18 months that may produce false resistant results in susceptibility testing.
Product
BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0583-2025·2024-12-11
Spectral CT Devices Pose Collision and Misdiagnosis Software Risks
Philips Spectral CT and Spectral CT Plus devices may fail to update plan positioning during interventional procedures, creating collision risks to operators and patients. A software defect may also assign incorrect patient IDs, potentially causing misdiagnosis.
Product
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Category
Medical Device
Distribution
Distributed nationwide