State

American Samoa product recalls

72,940 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 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5526–5550 of 72965

HighFDA (Devices)·Z-2286-2025·2025-08-20
EMPOWR 3D knee tibial inserts recalled over incorrect size or side labeling
Enovis is recalling 40 EMPOWR 3D Knee tibial inserts, catalog number 342-16-707, because the implants carry incorrect size or side labeling.
Product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0465-2025·2025-08-20
La Michoacana variety paletas list cream without declaring milk as source
La Michoacana Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 29,180 units are affected.
Product
La Michoacana Minis Variety Paletas 12-Count 16.5oz UPC: 7-67778-03042-3
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0460-2025·2025-08-20
Mango con crema paletas recalled for listing cream without milk allergen declaration
La Michoacana Mango Con Crema Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 24,228 units are affected.
Product
La Michoacana Mango Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00008-2
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0469-2025·2025-08-20
Helados Mexico variety paletas list cream without declaring milk as source
Helados Mexico Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 42,488 units are affected.
Product
Helados Mexico Minis Variety Paletas 12-Count 18oz UPC:6-82082-61215-1
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2283-2025·2025-08-20
Kittner gauze rolls had biological foreign matter and wrong pack quantity
Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze is being recalled for product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in sterile packaging.
Product
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0470-2025·2025-08-20
Helados Mexico choco dipped paletas list cream without declaring milk
Helados Mexico Choco Dipped Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 70,044 units affected.
Product
Helados Mexico Choco Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-41215-7
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0463-2025·2025-08-20
Coconut con crema 6-pack paletas recalled over undeclared milk in cream
La Michoacana Coconut Con Crema 6-Pack Paletas, 16.5 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 47,065 units are affected.
Product
La Michoacana Coconut Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00101-0
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2284-2025·2025-08-20
Kittner roll gauze with tail recalled over contamination and incorrect pack quantity
Carefree Surgical Specialties Kittner Roll Gauze + Tail, catalog 15506/25 lot 1607, is recalled for biological foreign matter that could compromise sterility and for incorrect gauze counts. 65 units are affected.
Product
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15506/25 Product Description: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0581-2025·2025-08-20
Metoprolol tartrate tablets recalled for nitrosamine above acceptable daily intake level
Metoprolol Tartrate Tablets USP, 50 mg, distributed by Westminster Pharmaceuticals, are recalled nationwide after N-nitroso-metoprolol was found above the established Acceptable Daily Intake. 16,672 bottles are affected.
Product
Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·H-0464-2025·2025-08-20
Strawberry con crema paleta 6-packs recalled for cream without milk declaration
La Michoacana Strawberry Con Crema 6-Pack Paletas, 16.5 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 33,105 units are affected.
Product
La Michoacana Strawberry Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00102-7
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0582-2025·2025-08-20
Metoprolol tartrate 100 mg tablets exceed the nitrosamine daily intake level
Metoprolol Tartrate Tablets USP 100 mg distributed by Westminster Pharmaceuticals are being recalled because N-nitroso-metoprolol was present above the established Acceptable Daily Intake level. 4,456 bottles affected.
Product
Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0586-2025·2025-08-20
Sodium chloride injection containers recalled over potential fluid leakage at weld site
B. Braun 0.9% Sodium Chloride Injection USP, 1000 mL Excel containers, lot J5C919, is recalled for lack of assurance of sterility because of potential fluid leakage at a weld site. 23,100 containers are affected.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0587-2025·2025-08-20
Glenmark carvedilol 12.5 mg tablets exceed the nitrosamine impurity limit
Carvedilol Tablets USP 12.5 mg from Glenmark are being recalled because N-Nitroso Carvedilol Impurity-1 was observed above the FDA-recommended limit of not more than 4.0 ppm. 17,496 bottles affected.
Product
CARVEDILOL — CARVEDILOL (CARVEDILOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2280-2025·2025-08-20
Cannulated fenestrated polyaxial screws recalled because they may be incorrectly labeled
PERLA TL MIS cannulated fenestrated polyaxial screws, model MPF-PS 55 45-S, lot 8-4266, are recalled because the screws may be incorrectly labeled.
Product
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0462-2025·2025-08-20
Cookies and cream paletas recalled because label lists cream without declaring milk
La Michoacana Cookies N Cream Single Serve Paletas, 3.75 oz, are recalled nationwide because the label names cream as an ingredient but does not declare milk as its source. 15,001 units are affected.
Product
La Michoacana Cookies N Cream Single Serve Paleta 3.75oz UPC: 7-67778-00007-5
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0576-2025·2025-08-20
Amlodipine and olmesartan tablets recalled after failing dissolution specification testing
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, lot 23121560, are recalled nationwide for low dissolution results. The recall covers 8,568 bottles.
Product
AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2287-2025·2025-08-20
Neurostimulator patient controllers recalled over cable disconnect errors interrupting stimulation output
Sparrow Ascent Patient Controllers are recalled because a manufacturing issue may produce a cable disconnect error message and interrupt stimulation output. 78 units are affected.
Product
Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0468-2025·2025-08-20
Mini variety paletas recalled because label lists cream without declaring milk
Helados Mexico Minis Variety Paletas, 12-count 18 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 643,519 units are affected.
Product
Helados Mexico Minis Variety Paletas 12-Count 18oz UPC: 6-82082-11215-6
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0466-2025·2025-08-20
Variety paleta 16-count packs recalled over cream ingredient missing milk source
La Michoacana Variety Paletas, 16-count 44 oz packs, are recalled nationwide because the label lists cream but does not declare milk as its source. 2,241 units are affected.
Product
La Michoacana Variety Paletas 16-Count 44oz UPC:7-67778-03100-0
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2293-2025·2025-08-20
High pressure tubing may separate and trap air in the line
High Pressure Tubing is being recalled because it may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 8,040 units affected.
Product
High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0588-2025·2025-08-20
Carvedilol 25 mg tablets recalled over nitrosamine impurity above FDA limit
Glenmark Carvedilol Tablets USP, 25 mg, in 500-tablet cartons are recalled nationwide after N-Nitroso Carvedilol Impurity-1 was found above the FDA-recommended limit. 14,976 bottles are affected.
Product
CARVEDILOL — CARVEDILOL (CARVEDILOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2295-2025·2025-08-20
Custom manifold kit tubing may separate and trap air in line
Custom Manifold Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 6,327 units affected.
Product
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2279-2025·2025-08-20
Polyaxial screws in lot 8-4528 recalled over possible incorrect labeling
PERLA TL MIS cannulated fenestrated polyaxial screws, model MPF-PS 65 40-S, lot 8-4528, are recalled because the screws may be incorrectly labeled. 16 units are affected.
Product
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2297-2025·2025-08-20
3mensio workstation clock measurements may place stent graft fenestrations incorrectly
3mensio Workstation (Vascular Fenestrated) software is being recalled because changing the 12h position of a single clock does not update other clock measurements, which may place stent graft fenestrations incorrectly. 501 units affected.
Product
3mensio Workstation (Vascular Fenestrated) software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2294-2025·2025-08-20
Custom tubing kits recalled because high pressure tubing may trap air
Custom Tubing Kits under REF K04-00417, K04-00963 and K04-01029 are recalled because high pressure tubing may separate from its connector and trap air that could reach the patient. 2,779 units are affected.
Product
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Category
Medical Device
Distribution
Distributed nationwide