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.

52701–52725 of 73858

SevereFDA (Devices)·Z-2198-2015·2015-07-29
Philips Recalls GEMINI TF Base CT/PET Systems Due to Software Defects
Philips is recalling two GEMINI TF Base CT/PET systems because four software defects in the Tumor LOC application may cause incorrect tissue irradiation.
Product
GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2111-2015·2015-07-29
FDA Recalls Sterile Surgical Kits with Compromised Gloves
The FDA is recalling 4,136 sterile surgical kits because the Devon Light Gloves inside contain splits or holes that compromise sterility.
Product
ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI Universal ASC Kit 50000512 7557-UNI Universal ASC Kit 50000515 7667-BRT Breast ASC Kit
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2156-2015·2015-07-29
FDA Recalls Sureflex 150 Lithotripsy Fibers Due to Sterilization Validation Issues
American Medical Systems is recalling Sureflex 150 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.
Product
Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2110-2015·2015-07-29
Surgical Set Up Kits Recalled Due to Sterility Compromise in Gloves
FDA is recalling 33,256 surgical set up kits containing Devon Light Gloves that have splits or holes compromising sterility.
Product
Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2197-2015·2015-07-29
Philips GEMINI TF Ready CT/PET System Software Defect Recall
Philips is recalling GEMINI TF Ready CT/PET systems due to software defects that may cause incorrect radiation treatment.
Product
GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Category
Medical Device
Distribution
Distributed nationwide
SevereCPSC·15200·2015-07-29
Jenn-Air Wall Ovens Recalled for Burn Risk from Roller Rack
Whirlpool is recalling Jenn-Air wall ovens because the extendable roller rack can unexpectedly disengage, posing a burn risk. Consumers should stop using the rack and contact Whirlpool for a free repair.
Product
Jenn-Air Single, Double Wall Ovens and Combination Microwave/Wall Ovens
Category
Consumer Product
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2175-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Tool, Stripper W/BLD, 12S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2136-2015·2015-07-29
Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values
Volcano Corporation is recalling s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may calculate inaccurate FFR/iFR values.
Product
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2116-2015·2015-07-29
FDA Recalls Sterile Augmentation Kits with Compromised Devon Light Gloves
The FDA is recalling 144 sterile Augmentation Kits containing Devon Light Gloves due to splits or holes that compromise sterility. The affected kits were distributed worldwide.
Product
Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2107-2015·2015-07-29
FDA Recalls Sterile Delivery Kits Containing Defective Devon Light Gloves
The FDA is recalling sterile delivery and C-section kits containing Devon Light Gloves with splits or holes that compromise sterility.
Product
Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY KIT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2115-2015·2015-07-29
FDA Recalls Sterile Single Basin Kits with Compromised Gloves
The FDA is recalling 77,588 sterile single basin kits because the Devon Light Gloves contain splits or holes that compromise sterility.
Product
Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Number/Description: 573509 7696-GSL-VL SINGLE BASIN KIT 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 31145645 7608 Single Basin KIT 31153060 7697-T4 Single Basin Kit 50000568…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2114-2015·2015-07-29
Recall of Sterile Major Kits with Defective Devon Light Gloves
FDA is recalling sterile Major Kits containing Devon Light Gloves due to splits or holes that compromise sterility.
Product
Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2152-2015·2015-07-29
Biomet Polaris 4.75 TI Spinal System Multiaxial Screws Recalled for Fatigue Strength
Biomet Spine is recalling 4,765 units of Polaris 4.75 TI Spinal System multiaxial screws because they may not meet internal fatigue strength requirements.
Product
Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2154-2015·2015-07-29
Bausch & Lomb SoFlex SE Intraocular Lens Recall for Haptic Breakage
Bausch & Lomb is recalling SoFlex SE foldable intraocular lenses because haptics may break during loading and insertion.
Product
Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2108-2015·2015-07-29
FDA Recalls Devon Light Gloves for Sterility Compromising Defects
The FDA is recalling specific lots of Devon Light Gloves because splits or holes may compromise sterility. The recall affects 559,108 kits distributed worldwide.
Product
Mini-Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description 31141479 K-1842-S OR Mini Kit 31141487 K-1560-S3 OR Mini Kit 31141495 K-1530-S3 OR Mini Kit 31141537 K-1940-S OR Mini Kit 31141552 K-1920-S OR Mini Kit 31141560 K-1200-S3 OR Mini Kit…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2179-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Tool, Stripper W/BLD, 18S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2162-2015·2015-07-29
FDA Recalls Sure F!ex Reusable Lithotripsy Fibers Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Sure F!ex reusable laser fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
200¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·15V476000·2015-07-29
Ford Recalls 2015 Lincoln MKT Vehicles Missing Second Row Seats
Ford is recalling 2015 Lincoln MKT vehicles delivered without second-row seats, creating a safety compliance issue and increased crash injury risk.
Product
LINCOLN — LINCOLN MKT
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2134-2015·2015-07-29
Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values
Volcano Corporation is recalling s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may cause inaccurate FFR/iFR values.
Product
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5i Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2122-2015·2015-07-29
GE Healthcare Precision RXi Digital System Monitor Suspension Recall
GE Healthcare is recalling Precision RXi Digital systems because a monitor fell from its suspension, posing an injury risk to patients or operators.
Product
GE Healthcare Precision RXi Digital system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2117-2015·2015-07-29
FDA Recalls Non-Sterile Devon Light Gloves Due to Splits and Holes
The FDA is recalling non-sterile Devon Light Gloves because they contain splits or holes that compromise sterility. The recall affects lots with numbers beginning 508xxxx or lower.
Product
NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2132-2015·2015-07-29
Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values
Volcano Corporation is recalling s5, s5i, and CORE Intravascular Ultrasound Systems due to a software issue that may calculate inaccurate FFR/iFR values.
Product
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5x. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2102-2015·2015-07-29
Stryker SelectCore Biopsy Device Recalled for Stylet Ejection Risk
Stryker is recalling 55 units of the SelectCore Variable Throw Biopsy Device because the stylet may eject during use.
Product
Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2097-2015·2015-07-29
Maquet Magnus Hybrid OR Table Column Recalled for Collision Risk
Maquet is recalling 12 Magnus Hybrid OR Table Columns due to a potential collision risk with the C-arm of the Siemens Artis Zeego Angiography System.
Product
Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2199-2015·2015-07-29
Philips Recalls GEMINI TF Big Bore CT/PET Systems Due to Software Defects
Philips is recalling 44 GEMINI TF Big Bore CT/PET systems worldwide because four software defects in the Tumor LOC application may cause incorrect tissue irradiation.
Product
GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Category
Medical Device
Distribution
Distributed nationwide