State

American Samoa product recalls

72,971 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 72,971 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

6601–6625 of 72996

SevereFDA (Devices)·Z-1701-2025·2025-05-07
L-Shaped Femoral Augment with Missing Screw Thread
Waldemar Link GmbH & Co. KG is recalling L-Shaped Femoral Augments because the preassembled femoral augment screw was missing its thread. The defect could affect the device's structural integrity during orthopedic surgery.
Product
L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4 - cemented sm), (6) 880-323/23 (Sz. 3-4 - cemented lg), (7)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1704-2025·2025-05-07
Enhanced Verify Evaluation Handset May Fail to Connect to Neurostimulator
Medtronic Enhanced Verify Evaluation Handsets (CFN HH90130FA) may fail to communicate with neurostimulators due to faster processing speed, causing therapy to stop and patients to experience return of underlying symptoms.
Product
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1626-2025·2025-05-07
GE Healthcare Carestation 620 SE Anesthesia System Ventilation Defect Recall
GE Healthcare is recalling certain Carestation 620 SE anesthesia systems (27 units) because they may not provide effective ventilation in Volume Control Ventilation mode. Alternative ventilation modes remain functional.
Product
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1629-2025·2025-05-07
GE Healthcare CARESTATION anesthesia systems may not ventilate effectively
Certain GE Healthcare CARESTATION 620, 650, 650c, 750, and 750c anesthesia delivery systems may not provide effective ventilation in Volume Control Ventilation (VCV) mode. Effective ventilation is available using other ventilation modes or manual ventilation.
Product
GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0398-2025·2025-05-07
Nicardipine Hydrochloride Injection Recalled for Potential Sterility Issues
American Regent, Inc. is recalling Nicardipine Hydrochloride Injection due to product leakage around the vial neck that could compromise sterility assurance. The recall affects multiple lots distributed nationwide.
Product
NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1625-2025·2025-05-07
GE Healthcare CARESTATION 620 A2 Anesthesia System Ventilation Failure
Certain GE Healthcare CARESTATION anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation (VCV) mode. Alternative ventilation modes or manual ventilation can be used.
Product
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1630-2025·2025-05-07
GE Healthcare Anesthesia Systems Recalled Over Ventilation Failure
GE Healthcare is recalling certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems because they may not provide effective ventilation in Volume Control Ventilation (VCV) mode. The issue does not affect Pressure Control Ventilation (PCV), PCV-VG, or manual ventilation modes.
Product
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1638-2025·2025-05-07
GE Healthcare CARESTATION Anesthesia Systems may not ventilate properly
GE Healthcare is recalling certain CARESTATION anesthesia systems that may fail to provide effective ventilation in Volume Control Ventilation mode. Alternative ventilation modes remain functional.
Product
GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1632-2025·2025-05-07
GE Healthcare CARESTATION 650C A1 Anesthesia System Ventilation Recall
GE Healthcare CARESTATION 650C A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Ventilation can be achieved using alternate modes or manual ventilation.
Product
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1637-2025·2025-05-07
GE Healthcare CARESTATION 750c A1 Anesthesia System Ventilation Defect
GE Healthcare CARESTATION 750c A1 anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode. Affected units can achieve ventilation through alternative modes or manual operation.
Product
GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1624-2025·2025-05-07
GE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
GE Healthcare CARESTATION 620 A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Effective ventilation is available in Pressure Control or Manual ventilation modes.
Product
GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1699-2025·2025-05-07
Distal Femoral Augment medical device recall for defective screw
Waldemar Link GmbH & Co. KG is recalling Distal Femoral Augment devices because the preassembled femoral augment screw was missing its thread. The defect may affect proper device function.
Product
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 88
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1702-2025·2025-05-07
Tibial Augment devices recalled for missing screw thread
Waldemar Link GmbH & Co. KG is recalling Tibial Augment devices distributed nationwide because preassembled Femoral Augment screws were delivered missing their threads.
Product
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1635-2025·2025-05-07
GE Healthcare CARESTATION 750 Anesthesia System Volume Control Ventilation Failure
Certain GE Healthcare CARESTATION 750 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Affected systems can deliver ventilation through alternative modes or manual ventilation.
Product
GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1636-2025·2025-05-07
GE Healthcare CARESTATION Anesthesia Systems Ventilation Mode Failure Recall
Certain GE Healthcare CARESTATION 750 A2 anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode. Users should switch to Pressure Control Ventilation or Manual ventilation modes.
Product
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1700-2025·2025-05-07
Posterior Femoral Augment with Missing Screw Thread Recalled
Waldemar Link is recalling Posterior Femoral Augments used in knee surgery because some units were delivered with a preassembled screw missing its thread, which could compromise surgical fixation.
Product
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1628-2025·2025-05-07
GE Healthcare Carestation 650 A1 Anesthesia System Ventilation
Certain GE Healthcare Carestation 650 A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Alternative ventilation modes or manual ventilation can be used.
Product
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1633-2025·2025-05-07
GE Healthcare CARESTATION Anesthesia Systems Volume Control Ventilation Failure
GE Healthcare CARESTATION anesthesia delivery systems may fail to provide effective ventilation in Volume Control Ventilation mode. Affected units can deliver ventilation through Pressure Control Ventilation modes or manual ventilation.
Product
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1634-2025·2025-05-07
GE Healthcare Carestation 650c A1 Anesthesia System Ventilation Failure
GE Healthcare is recalling certain Carestation 650c A1 anesthesia systems worldwide because they may not provide effective ventilation in Volume Control Ventilation mode, limiting patient ventilation options during anesthesia delivery.
Product
GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1675-2025·2025-05-07
Belmont Straight Inflow/Outflow Patient Line Kit recalled for potential connector crack
Belmont Instrument LLC is recalling the Straight Inflow/Outflow Patient Line Kit (Model 902-00037) due to a potential crack in the female connector on the Heat Exchanger set that may cause fluid leaks during use.
Product
Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00037) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1711-2025·2025-05-07
Medline Wound Care and Laceration Procedure Kits Recalled for Leaking Bottles
Medline is recalling Sterile Water and Sterile 0.9% Normal Saline bottles in wound care and laceration procedure kits due to leaking at the peel-foil and bottle opening interface.
Product
Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1673-2025·2025-05-07
Stratus CS Acute Care cTNI TestPak cardiac troponin test recall
Siemens Healthcare Diagnostics is recalling Stratus CS Acute Care cTNI TestPak, a cardiac troponin I test, due to an increased occurrence of false positive results during the product's shelf life.
Product
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1672-2025·2025-05-07
Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer Recall
Beckman Coulter is recalling certain DxC 500 AU Clinical Chemistry Analyzers due to incorrect sample barcode identification and processing errors that can result in erroneous and delayed test results.
Product
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that meas
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1684-2025·2025-05-07
epoc BGEM BUN Test Cards for Blood Analysis System Recalled
Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Cards (25 pk) due to discrepant high pH results when samples are introduced with higher injection volumes on affected sensor configurations.
Product
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0396-2025·2025-05-07
Levothyroxine Sodium Tablets 88 mcg Recall for Subpotency
Accord Healthcare is recalling Levothyroxine Sodium Tablets 88 mcg (Lot D2300044, expiring 12/2025) nationwide because the tablets are subpotent—below the required strength. Patients on this medication should contact their pharmacy or prescriber.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide