State

American Samoa product recalls

73,833 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: 9
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 9 (36%) are Severe.

Which agencies issued them

These figures cover only the 25 recalls whose distribution notice names American Samoa specifically. The 73,833 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

53901–53925 of 73858

HighFDA (Devices)·Z-1552-2015·2015-05-06
Fresenius 2008K2 Hemodialysis Machines Recalled for Acetate Display Error
Fresenius Medical Care is recalling 2008K2 hemodialysis machines because the GranuFlo acetate value is incorrectly displayed as 4mEq/l instead of 8mEq/l on the Select Concentrate screen.
Product
2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 190618 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; 190610 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; 190630 2008K2 MACHINE, SHORT CAB, OLC/DP, HP…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1529-2015·2015-05-06
Beckman Coulter Recalls MicroScan Panels Due to Performance Limitation
Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.
Product
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B1017-417 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0972-2015·2015-05-06
Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization
Hospira Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection due to crystallization. The recall covers products distributed nationwide, in Puerto Rico, and in Guam.
Product
Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1527-2015·2015-05-06
MedComp Recalls 9F Plastic Dual Port Vascular Access Devices
Medical Components, Inc. is recalling 325 units of 9F Plastic Dual Port vascular access devices because they were not covered under FDA clearance.
Product
9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0970-2015·2015-05-06
Teva Recalls Fluoxetine Capsules Due to Residual Solvent Impurity
Teva Pharmaceuticals USA is recalling specific lots of Fluoxetine Capsules 10 mg due to an elevated level of a residual solvent impurity in the active ingredient.
Product
FLUOXETINE — FLUOXETINE (FLUOXETINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1528-2015·2015-05-06
Beckman Coulter MicroScan Panels Recalled for Missing Proteus Performance Warning
Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin failed to mention performance limitations for Proteus mirabilis.
Product
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg Combo 50, Catalog B1017-406 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1530-2015·2015-05-06
Beckman Coulter MicroScan Panels Recalled for Missing Proteus Limitation
Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.
Product
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 51, Catalog B1017-407 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1551-2015·2015-05-06
Fresenius 2008K Hemodialysis Machines Recalled for Acetate Display Error
Fresenius Medical Care is recalling 2008K hemodialysis machines because the GranuFlo acetate value is incorrectly displayed as 4mEq/l instead of 8mEq/l on the Select Concentrate screen.
Product
2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1539-2015·2015-05-06
Therasage FAR-Infrared Heat Home Sauna Recalled for Lack of FDA Approval
Therasage, LLC. is recalling its FAR-Infrared Heat Home Sauna because the product was distributed without the required FDA 510(k) approval.
Product
FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1538-2015·2015-05-06
Coloplast Genesis Malleable Penile Prosthesis Mislabeled Size Recall
Coloplast is recalling 11 units of the 9.5 mm Genesis Malleable Penile Prosthesis because the retail box and patient labels incorrectly state the size as 9 mm.
Product
Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1525-2015·2015-05-06
Biosense Webster HIS Catheter Recall Due to Navigation System Compatibility Issue
Biosense Webster is recalling 503 Webster HIS Catheters because they are not recognized by the CARTO 3 navigation system.
Product
WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1534-2015·2015-05-06
Beckman Coulter Recalls MicroScan Dried Gram Negative MIC Panels
Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.
Product
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: ES¿L plus, Catalog B1027-101 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1532-2015·2015-05-06
Beckman Coulter Recalls MicroScan Dried Gram Negative MIC Panels
Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin failed to mention performance limitations for Proteus mirabilis and Imipenem.
Product
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 61, Catalog B1017-414 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1524-2015·2015-05-06
Beckman Coulter Recalls MicroScan Pos Combo 33 Panels Due to Missing Desiccants
Beckman Coulter is recalling 664 boxes of MicroScan Pos Combo 33 panels because some were packaged without desiccants, which may cause substrate deterioration.
Product
MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1535-2015·2015-05-06
Biocare Medical Recalls CD99 In Vitro Diagnostic Reagent Lots
Biocare Medical is recalling specific lots of CD99 in vitro diagnostic reagents because staining intensity has decreased over time, potentially affecting shelf life.
Product
CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1540-2015·2015-05-06
Therasage FAR-Infrared Heat Home Sauna Recalled for Lack of FDA Approval
Therasage, LLC. is recalling FAR-Infrared Heat Home Saunas because they were distributed without FDA 510(k) approval.
Product
FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1544-2015·2015-05-06
Integra Tuohy Needles Recalled for Incorrect Length Labeling
Integra LifeSciences is recalling 90 Tuohy needles that were incorrectly labeled as 5 inches when they are actually 3.5 inches.
Product
Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850. Used to administer steroid medication in the epidural space.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1550-2015·2015-05-06
Fresenius 2008T Hemodialysis Machines Recalled for Acetate Display Error
Fresenius Medical Care is recalling 2008T hemodialysis machines because the Select Concentrate screen incorrectly displays the GranuFlo acetate value as 4mEq/l instead of 8mEq/l.
Product
2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1541-2015·2015-05-06
Therasage Portable FAR Infrared Sauna Recalled for Lack of FDA Approval
Therasage, LLC. is recalling 8 portable FAR infrared saunas because they were distributed without FDA 510(k) approval.
Product
Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1522-2015·2015-05-06
Beckman Coulter Recalls MicroScan Neg Breakpoint Combo Panel Type 34
Beckman Coulter is recalling 681 boxes of MicroScan Neg Breakpoint Combo Panel Type 34 due to reported panel degradation.
Product
MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to No.1 the species level of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1558-2015·2015-05-06
Teleflex Medical Recalls Hudson RCI ConchaTherm Neptune Heated Humidifiers
Teleflex Medical is recalling 7,228 Hudson RCI ConchaTherm Neptune Heated Humidifiers because customer complaints reported the power ceasing and the display going blank.
Product
Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1531-2015·2015-05-06
Beckman Coulter Recalls MicroScan Microbiology Panels Due to Performance Limitation
Beckman Coulter is recalling MicroScan Microbiology Systems panels because a 2013 bulletin failed to mention a performance limitation for Proteus mirabilis and Imipenem.
Product
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 55, Catalog B1017-409 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1549-2015·2015-05-06
Fresenius 2008 Hemodialysis Machines Recalled for Acetate Display Error
Fresenius Medical Care is recalling 2008 Series Hemodialysis Machines because the Acetate value for GranuFlo is displayed incorrectly on the Select Concentrate screen.
Product
2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX The Fresenius 2008K…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1533-2015·2015-05-06
Beckman Coulter Recalls MicroScan Dried Gram Negative MIC Panels
Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin failed to mention performance limitations for Proteus mirabilis and Imipenem.
Product
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg MIC 38, Catalog B1017-412 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1537-2015·2015-05-06
GA Industries Recalls Logicon Caries Detector for Lack of FDA Approval
GA Industries is recalling the Logicon Caries Detector software because it was released without FDA approval.
Product
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and…
Category
Medical Device
Distribution
Distributed nationwide