State

Northern Mariana Islands product recalls

73,503 recalls have nationwide distribution and so reach Northern Mariana Islands. 23 additional recalls listed Northern Mariana Islands specifically in their distribution scope.

What the numbers show

Total: 23
Critical: 0
Severe: 18
Most recent: 2026-09-23

Of the 23 recalls naming Northern Mariana Islands we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 18 (78%) are Severe.

Which agencies issued them

These figures cover only the 23 recalls whose distribution notice names Northern Mariana Islands specifically. The 73,503 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

24526–24550 of 73526

HighFDA (Devices)·Z-1838-2021·2021-06-16
Medical Device Software Defects in RayStation Treatment Planning System
RayStation radiation therapy treatment planning software versions 6 through 10A contain defects that may cause misleading dose evaluations and contouring errors. Healthcare facilities should verify treatment plans and contact the manufacturer for guidance.
Product
RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 or 10.1.0.613 .
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1820-2021·2021-06-16
Atec Insignia Anterior Cervical Plate System Screw Mechanism Recall
Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to potential disassociation or postoperative unlock of the screw blocking mechanism during or after cervical spine surgery.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01)00190376268606
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1801-2021·2021-06-16
Anterior cervical plate system screw mechanism may disassociate during or after surgery
Alphatec Spine's Atec Insignia Anterior Cervical Plate System has a potential defect where the screw blocking mechanism may disassociate during or after surgery, which could compromise spinal stabilization.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (01)00190376268446
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1803-2021·2021-06-16
Cervical Spine Plate System Screw Mechanism May Disassociate or Unlock
Alphatec Spine recalls its Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism, which may disassociate or unlock during or after spinal surgery.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1824-2021·2021-06-16
Alphatec Insignia Cervical Plate System: Screw Mechanism Disassociation Risk
Alphatec recalls the Insignia Anterior Cervical Plate System due to risk that the screw blocking mechanism may disassociate during or after surgery.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1822-2021·2021-06-16
Anterior Cervical Plate System Screw Mechanism Recall
Alphatec Spine recalls Atec Insignia Anterior Cervical Plate Systems because the screw blocking mechanism may fail during or after surgery. The mechanism may disassociate or unlock, potentially compromising implant stability.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1842-2021·2021-06-16
FDA Recalls Olympus Sterile Optical Laser Fibers for Potential Sterility Compromise
Quanta System is recalling Olympus Sterile Optical Laser Fibers nationwide due to potentially compromised sterility. Approximately 26,925 units distributed through six U.S. distributors are affected.
Product
Olympus Sterile Optical Laser Fiber, single use and reusable
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1815-2021·2021-06-16
Anterior Cervical Plate System Recalled for Potential Screw Mechanism Failure
Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism could disassociate or unlock during or after cervical spine surgery.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268538
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1846-2021·2021-06-16
Radiotherapy positioning software may delay patient movement display
Brainlab's ExacTrac Dynamic radiotherapy positioning software may delay display of patient movement during high-dose treatments, risking treatment precision errors. 22 systems affected across 11 U.S. states.
Product
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1814-2021·2021-06-16
Anterior Cervical Plate System Screw Mechanism May Disassociate or Unlock
Alphatec Spine recalls its Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate during spinal surgery or unlock afterward. Healthcare providers should contact the manufacturer for guidance.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1827-2021·2021-06-16
Anterior cervical plate system screw blocking mechanism defect recalled
Alphatec Spine's Atec Insignia anterior cervical plate system has a defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1809-2021·2021-06-16
Anterior cervical plate system screw blocking mechanism may disassociate
Alphatec Spine Inc. is recalling the Atec Insignia anterior cervical plate system because the screw blocking mechanism may disassociate intraoperatively or unlock postoperatively. No injuries reported.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1823-2021·2021-06-16
Anterior cervical plate system screw mechanism may disassociate or unlock
The Alphatec Insignia anterior cervical plate system may have a defect where the screw blocking mechanism disassociates during surgery or unlocks afterward. Consult your doctor if you have this implant.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1811-2021·2021-06-16
Alphatec Insignia Anterior Cervical Plate System screw locking mechanism failure
Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential failure in the screw locking mechanism. The mechanism may disassociate or unlock during or after spinal surgery.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1817-2021·2021-06-16
Atec Insignia Anterior Cervical Plate System Screw Blocking Mechanism Risk
The FDA is recalling certain Atec Insignia Anterior Cervical Plate Systems due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1821-2021·2021-06-16
Anterior Cervical Plate System Screw Blocking Mechanism May Disassociate
Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism. The screws may disassociate or unlock during or after surgery, risking implant failure.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1806-2021·2021-06-16
Anterior Cervical Plate System Screw Lock Mechanism May Fail Intraoperatively or Postoperatively
The Alphatec Insignia Anterior Cervical Plate System is recalled because the screw blocking mechanism may disassociate intraoperatively or unlock postoperatively. Eight units were distributed across 15 U.S. states.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1799-2021·2021-06-16
Alphatec Insignia Anterior Cervical Plate System screw failure recalled
Alphatec is recalling its Insignia Anterior Cervical Plate System due to potential screw blocking mechanism failure during or after spinal surgery. The screw may disassociate intraoperatively or unlock postoperatively.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1810-2021·2021-06-16
Anterior cervical plate system may lose screw locking mechanism during surgery
Alphatec Spine's Insignia Anterior Cervical Plate System may have a defective screw blocking mechanism that could disassociate during or after surgery. The FDA has recalled 19 units distributed across 15 US states.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01)00190376268392
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1840-2021·2021-06-16
Myriad-LX Light Source Recalled Due to Burn and Occlusion Risk
Nico Corp. is recalling 80 Myriad-LX Light Source units due to potential burn injury to patients from the distal tip of the fiber assembly and risk of delivery sleeve occlusion during surgical use.
Product
Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 The Myriad-LX light source is a high-intensity 300W Xenon illuminator with a touch screen and digital dimming controls. The source is…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1825-2021·2021-06-16
Cervical Plate System screw locking mechanism may fail during or after surgery
Alphatec Insignia Anterior Cervical Plate System screw blocking mechanism may disassociate during surgery or unlock afterward. No injuries reported.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1837-2021·2021-06-16
Sunstar G.U.M Perioshield Oral Rinse Recalled Due to Bacterial Contamination
Sunstar Americas is recalling SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse 300mL (SKU 1775P, 1775R) due to potential contamination with Burkholderia bacteria.
Product
SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1819-2021·2021-06-16
Anterior Cervical Plate System Recalled for Screw Locking Failure
Alphatec Spine is recalling its Insignia Anterior Cervical Plate System due to potential failure of the screw blocking mechanism during or after surgery that could compromise implant stability.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01)00190376268590
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1818-2021·2021-06-16
Alphatec Insignia Anterior Cervical Plate: Screw Blocking Mechanism May Disassociate
Alphatec Spine is recalling the Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate during or after spinal surgery.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1826-2021·2021-06-16
Atec Insignia Cervical Plate Screw Locking Mechanism May Fail
Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to potential failure of the screw blocking mechanism that could cause separation during or after surgery.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705
Category
Medical Device
Distribution
Distributed nationwide