State

American Samoa product recalls

73,486 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 73,486 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

23576–23600 of 73511

HighFDA (Devices)·Z-2378-2021·2021-09-08
Baxter PrismaFlex Dialysis Tubing Sets Recalled Due to Sterilization Failure
Baxter PrismaFlex dialysis tubing sets are being recalled because products labeled sterile may not have been properly sterilized due to sterilization contractor failures and data integrity issues.
Product
Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2357-2021·2021-09-08
Medical Imaging Software Bug May Cause Incorrect X-ray Exposure
Philips CombiDiagnost R90 imaging software has a bug where exposure settings may change unexpectedly, resulting in over or under-exposed X-ray images. About 66 systems in the US are affected.
Product
CombiDiagnost R90 Software Version R1.0 and R1.1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2381-2021·2021-09-08
COVID-19 Antibody Test Kit Recalled for Failing Validation Requirements
Thera Test Laboratories is recalling 11 EL-Anti-SARS-CoV-2 IgM test kits distributed across six states because they failed to meet FDA's updated validation requirements for accurately detecting COVID-19 antibodies.
Product
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2385-2021·2021-09-08
Diamondback 360 Gen2 Orbital Atherectomy System Crown Size Mislabeling Recall
Cardiovascular Systems Inc. is recalling 8 units of the Diamondback 360 Gen2 Peripheral Orbital Atherectomy System due to potential mislabeling of crown sizes. Units packaged as 1.50mm Solid Crown may actually be 1.25mm Micro Crown and vice versa.
Product
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2389-2021·2021-09-08
Marco Shoulder Stabilization Kit Recall Due to Sterilization Failure
Aspen Surgical Products is recalling 4,270 Marco Shoulder Stabilization Kits manufactured between July 2019 and July 2021 due to bioburden levels exceeding sterilization validation limits, which may compromise sterile fields and increase infection risk.
Product
Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21C004000·2021-09-08
Dorel Maxi-Cosi Pria 70 Child Seat Recall for Tether Anchor Defect
Dorel Juvenile Group is recalling Maxi-Cosi Pria 70 convertible child seats because they may not adequately protect children from head injury in a crash if installed without a top tether.
Product
CHILD SEAT:VEHICLE TETHER ANCHOR recall
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2379-2021·2021-09-08
Baxter Prismaflex Dialysis Membranes Recalled for Sterilization Failure
Baxter is recalling Prismaflex HF 1000 dialysis membranes (Lot 20B2330M) because products labeled as sterile may not have been properly sterilized due to manufacturing defects and data manipulation. Non-sterile devices could pose infection risks to patients.
Product
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V696000·2021-09-08
Blue Bird Recalls 2022 Vision School Buses for Camera Obstruction
Blue Bird is recalling 2022 Vision school buses because the collision mitigation camera may block the driver's view of the passenger side cross-view mirror, increasing pedestrian injury risk.
Product
BLUE BIRD — BLUE BIRD VISION SCHOOL BUS
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2384-2021·2021-09-08
MY01 Continuous Compartmental Pressure Monitor Recalled for Out-of-Specification Needle
MY01, INC. is recalling the MY01 Continuous Compartmental Pressure Monitor (37 units) due to an incorrect needle with out-of-specification trocar geometry. The affected devices may require higher force to penetrate patient skin.
Product
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2382-2021·2021-09-08
FDA Recalls COVID-19 Antibody Test Kits for Increased False Positive Risk
Thera Test Laboratories is recalling EL-Anti-SARS-CoV-2 IgG kits due to cross-reactivity that may produce false positive results. The recalled lot numbers are 05204351 and 05204368, affecting distribution in six US states.
Product
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2380-2021·2021-09-08
Surgical Instrument Recall: Failed Adhesive May Cause Tissue Burns
Olympus recalls Gyrus Acmi PKS surgical instruments due to expired adhesive that could fail, potentially causing foreign body reactions or electrical burns to patients.
Product
Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2404-2021·2021-09-08
Siemens Artis Angiography Systems Software Error May Delay Clinical Treatment
Certain Siemens Artis angiography systems with software version VD12 may fail to start up properly due to a software error, potentially delaying clinical imaging procedures. The issue affects specific units identified by serial number.
Product
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2409-2021·2021-09-08
Healgen COVID-19 Rapid Test Cassette Recalled Due to Unauthorized Laboratory Distribution
Healgen COVID-19 IgG/IgM Rapid Test Cassettes were distributed to laboratories not certified under CLIA, violating Emergency Use Authorization requirements. Unauthorized labs may produce inaccurate test results.
Product
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2388-2021·2021-09-08
Surgical arm suspension kits recalled due to sterilization concerns
Aspen Surgical Products is recalling Jessie Sterile Arm Suspension Kits due to bioburden levels exceeding sterilization validation limits. This may compromise the sterile field and increase infection risk.
Product
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0789-2021·2021-09-08
China-Gel Topical Pain Reliever Recalled for Manufacturing Facility Contamination
China-Gel Inc is recalling China-Gel White topical pain reliever products due to potential contamination with Burkholderia cepacia found at the manufacturing facility. The recall affects multiple package sizes distributed nationwide and internationally.
Product
CHINA-GEL — CHINA-GEL (MENTHOL AND CAMOHOR (SYNTHETIC))
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0788-2021·2021-09-08
China-Gel Topical Pain Reliever Recall Due to Manufacturing Contamination
China Gel Inc is recalling China-Gel (menthol and camphor) topical pain reliever products due to contamination with B. cepacia found in the manufacturing facility where the product was made.
Product
CHINA-GEL — CHINA-GEL (MENTHOL AND CAMOHOR (SYNTHETIC))
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0790-2021·2021-09-08
Topical Pain Relief AULIEF Recalled for Facility Contamination Risk
China Gel Inc is recalling AULIEF topical pain relief (menthol and camphor) because the product was manufactured in a facility where Burkholderia cepacia contamination was found in other products.
Product
AULIEF — AULIEF (MENTHOL AND CAMOHOR)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0786-2021·2021-09-08
Akorn Artificial Tears Ointment Recalled for Non-Sterility
Akorn, Inc. is recalling Artificial Tears Ointment eye lubricant due to failure of sterility testing. The product may be contaminated with Bacillus cereus.
Product
Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2386-2021·2021-09-08
Peripheral Atherectomy Devices Recalled Due to Crown Size Mislabeling
Cardiovascular Systems Inc is recalling STEALTH 360 GEN2 peripheral atherectomy devices due to potential mislabeling of crown sizes. Some 1.50mm crowns may be labeled as 1.25mm and vice versa, potentially affecting device performance.
Product
STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2390-2021·2021-09-08
Norton Arm Kit surgical device recall due to sterilization failure
Aspen Surgical Products is recalling 124 Norton Arm Kits due to bioburden levels exceeding sterilization validation limits, creating potential risk of surgical site infection.
Product
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2408-2021·2021-09-08
FaStep COVID-19 Test Devices Recalled for Unauthorized Laboratory Distribution
Versea Diagnostics recalled 563,290 FaStep COVID-19 antibody test devices that were distributed to laboratories not certified under federal standards. The devices were authorized only for use in CLIA-certified laboratories.
Product
FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0775-2021·2021-09-08
Cyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination
Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg due to out-of-specification microbial test results in an excipient batch. The affected product was distributed nationwide.
Product
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0774-2021·2021-09-08
Cyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination
Teva Pharmaceuticals is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg due to out-of-specification microbial counts in an ingredient batch. The product was distributed nationwide.
Product
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0787-2021·2021-09-08
Clopidogrel Tablets Recalled for Foreign Matter Contamination
Macleods Pharma USA is recalling Clopidogrel 75 mg tablets due to the presence of foreign matter in the product. The affected lot was distributed nationwide.
Product
CLOPIDOGREL — CLOPIDOGREL (CLOPIDOGREL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2393-2021·2021-09-08
Steripath Luer Transport Pack Gen2 Recalled for Incorrect Instructions
Magnolia Medical Technologies is recalling 9,400 units of Steripath Luer Transport Pack Gen2 because they were shipped with incorrect Transfer Adapter Instructions For Use (IFU).
Product
Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer¿ Blood Collection or Urine Collection Tubes.
Category
Medical Device
Distribution
Distributed nationwide