State

Nebraska product recalls

72,992 recalls have nationwide distribution and so reach Nebraska. 4,547 additional recalls listed Nebraska specifically in their distribution scope.

What the numbers show

Total: 4,547
Critical: 705
Severe: 1,119
Most recent: 2026-09-09

Of the 4,547 recalls naming Nebraska we have scored against our rubric, 705 (16%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,119 (25%) are Severe.

Which agencies issued them

These figures cover only the 4,547 recalls whose distribution notice names Nebraska specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8076–8100 of 77539

HighFDA (Devices)·Z-1025-2025·2025-02-05
AXIOS Stent Delivery System: Detaching Outer Sheath May Prevent Stent Expansion
Boston Scientific is recalling 1,144 AXIOS Stent Delivery System units because the outer sheath's distal black tip can detach. If this occurs, the tip may remain around the stent saddle and prevent proper stent expansion, requiring device exchange.
Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1054-2025·2025-02-05
Karl Storz Pediatric Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz Endoscopy is recalling its Pediatric Uretero-Renoscope 7.3 Fr. due to unapproved reprocessing instructions. The device instructions contain procedures not reviewed or approved by the FDA for safety and efficacy.
Product
KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1035-2025·2025-02-05
Stent system outer sheath may detach, preventing proper expansion
Boston Scientific's HOT AXIOS Stent has a reported defect where the outer sheath distal black tip can detach, preventing proper stent expansion and requiring device exchange.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1026-2025·2025-02-05
AXIOS stent delivery system outer sheath detachment prevents proper expansion
Boston Scientific recalls 1,399 units of AXIOS stent delivery systems due to outer sheath detachment that can prevent proper device expansion, requiring procedure prolongation and device exchange.
Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1027-2025·2025-02-05
AXIOS Stent Delivery System Outer Sheath May Detach During Use
The AXIOS Stent with Electrocautery-Enhanced Delivery System may have a defective outer sheath that can detach and prevent proper stent expansion, requiring device replacement during the procedure.
Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1032-2025·2025-02-05
Outer Sheath Detachment in HOT AXIOS Stent Delivery System
Boston Scientific's HOT AXIOS stent delivery system may have an outer sheath that detaches and prevents proper stent expansion. The defective tip can remain around the stent, requiring device exchange during the procedure.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1021-2025·2025-02-05
Design Options Combined Spinal/Epidural Tray Recalled for Connector Defect
B. Braun Medical is recalling 1,090 units of the Design Options Combined Spinal/Epidural Tray due to an incorrect catheter connector that cannot securely connect to the epidural catheter, preventing medication administration.
Product
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1066-2025·2025-02-05
Infinity Central Station speakers may fail to produce critical patient alarms
Edifier speakers in Draeger's Infinity Central Station may not produce audible alarms when in analog mode, potentially delaying patient treatment. Approximately 1,013 units are affected worldwide.
Product
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of dat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1037-2025·2025-02-05
HOT AXIOS Stent System Recalled Due to Outer Sheath Detachment Risk
Boston Scientific is recalling HOT AXIOS Stent systems due to potential outer sheath detachment that can prevent proper stent expansion. This defect may require device replacement during the procedure.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1060-2025·2025-02-05
Karl Storz Ureteroscope Recall Due to Unapproved Reprocessing Instructions
Karl Storz ureteroscopes are being recalled because their instructions contain reprocessing procedures that have not been reviewed or approved by the FDA. The recall affects 3,069 units distributed nationwide.
Product
KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1055-2025·2025-02-05
Karl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions
Karl Storz Endoscopy has recalled the KARL STORZ ENDOSKOPE Uretero-Renoscope nationwide because its instructions for use contain reprocessing procedures that lack FDA review and approval for safety and efficacy.
Product
KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1040-2025·2025-02-05
Medline Procedure Kits Recalled for Surgical Mask Bioburden Testing Failure
Medline has recalled 749 procedure kits containing surgical masks that failed to meet bioburden testing standards under EN 14683. The affected kits were distributed nationwide.
Product
Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1034-2025·2025-02-05
Boston Scientific HOT AXIOS Stent Delivery Systems Recalled for Component Detachment
Boston Scientific is recalling HOT AXIOS Stent systems because the outer sheath's tip can detach and prevent proper stent expansion, requiring device replacement during procedures.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1064-2025·2025-02-05
Karl Storz Ureteroscope Recalled for Unapproved Reprocessing Instructions
Karl Storz ureteroscopes contain reprocessing instructions that have not been reviewed and approved by the FDA. Affected devices should not be reprocessed using unapproved methods.
Product
KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1057-2025·2025-02-05
Karl Storz Uretero-Renoscope with Unapproved Reprocessing Instructions Recalled
Karl Storz Endoscopy is recalling 59 units of its uretero-renoscope due to instructions for use containing reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
Product
KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1028-2025·2025-02-05
AXIOS Stent Distal Tip Detachment Prevents Proper Expansion
Boston Scientific is recalling AXIOS Stent devices due to outer sheath distal tip detachment that can prevent proper stent expansion and require device replacement during the procedure.
Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1038-2025·2025-02-05
Knee implant articular surface recalled for incorrect metal post assembly
Zimmer, Inc. is recalling NexGen LCCK knee implant articular surface components due to incorrect assembly of the metal support post. The defect was identified internally in a small number of units.
Product
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1069-2025·2025-02-05
Bedside cardiac monitor system recalled for display distortion
The muRata Vios Monitoring System Model 2050 bedside cardiac monitor has been recalled due to a software issue causing patient vital signs and ECG waveforms to flicker and become distorted on the Central Station Monitor. No injuries have been reported.
Product
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1051-2025·2025-02-05
Karl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling a uretero-renoscope surgical device (REF 27003L) because the reprocessing instructions in the product documentation have not been reviewed or approved by the FDA.
Product
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1041-2025·2025-02-05
Medline procedure kits recalled for surgical masks failing sterilization tests
Medline SHORT TERM INFUSAPORT ACCESS KIT with reorder number DYNDC3188 is recalled because included surgical masks failed bioburden testing, potentially compromising sterility during procedures.
Product
Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1031-2025·2025-02-05
AXIOS Stent Delivery System recalled due to distal sheath detachment
Boston Scientific is recalling 38 units of AXIOS Stent and Delivery System (15mmx10mm) because the outer sheath's distal tip may detach, preventing proper stent expansion and requiring device replacement.
Product
AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0213-2025·2025-02-05
Prescription Drug Inflectra Recalled Nationwide for Manufacturing Quality Deviations
McKesson is recalling Inflectra (infliximab-dyyb) injectable drug due to manufacturing quality deviations. A batch intended for quarantine was inadvertently distributed to patients nationwide.
Product
INFLECTRA — INFLECTRA (INFLIXIMAB-DYYB)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1067-2025·2025-02-05
Implantable VNS Therapy Generators May Stop Delivering Treatment
LivaNova is recalling approximately 8,223 SenTiva VNS Therapy generators due to a potential internal component failure that may cause the implanted device to stop delivering seizure therapy. Affected patients should contact their physician.
Product
Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and exte
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1033-2025·2025-02-05
HOT AXIOS Stent Delivery System Outer Sheath May Detach, Preventing Stent Expansion
Boston Scientific's HOT AXIOS stent delivery system has a defect where the outer sheath can detach and prevent proper stent expansion, requiring device replacement.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1020-2025·2025-02-05
HemosIL Heparin Calibrators Recalled Over Quality Control Test Failures
Instrumentation Laboratory recalls HemosIL Heparin Calibrators worldwide due to quality control failures. The diagnostic controls did not meet expected performance standards, potentially affecting accuracy of heparin testing in clinical laboratories.
Product
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide