Medline robotic hysterectomy procedure kits recalled for elevated endotoxin
Medline Industries is recalling robotic hysterectomy procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may indicate out-of-specification product in distribution worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving elevated endotoxin levels on a surgical product used in direct patient contact during invasive procedures. The source text does not report any actual illnesses or injuries, but elevated endotoxin is a risk-of-harm hazard in this device category; the potential for harm justifies a High severity score.
Plain-English summary
Medline Industries, LP is recalling three robotic hysterectomy procedure kits (SKU DYNJ904269B, DYNJ904269C, and DYNJ904269D), which contain Medline Neuro Sponges. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
The recalled kits have been distributed worldwide. A total of 632 kits are subject to this recall, with multiple lot numbers identified for each kit type.
Hospitals and surgical facilities that have received these kits should immediately stop using them and contact Medline Industries, LP for instructions on return or replacement. Healthcare providers should review their inventory using the provided lot numbers and kit SKUs to identify affected units.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B; 2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269C; 3. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269D.
- Manufacturer
- Medline Industries, LP
- Affected units
- 632
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Medline Kit Number/SKU DYNJ904269B: UDI/DI each 10193489251630
- UDI/DI case 40193489251631
- Lot Number: 21KBM212
- Lot Number: 21IBT678
- Lot Number: 21GBF973
- Lot Number: 21EBR775
- Lot Number: 21DBH715
- Lot Number: 21BBI962
- Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079
- UDI/DI case 40195327040070
- Lot Number: 22HBO534
- Lot Number: 22FBY086
- Lot Number: 22FBG752
- Lot Number: 22CBY116
- Lot Number: 22ABS155
- Lot Number: 21LBF114
- Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938
- UDI/DI case 40195327275939
- Lot Number: 23JBN926
- Lot Number: 23FBE547
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 31 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 31 products in this recall →Related recalls
Same manufacturer · Medline Industries, LP
See all →- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Homecare Beds Recalled for Fire Hazard in Hand Control Pendant
FDA (Devices) · 2026-10-07
- SevereMedline Homecare Bed Hand Pendants Recalled for Fire Hazard
FDA (Devices) · 2026-10-07
- HighMedline Instrument Channel Brush Kits Recalled for Sharp Edges
FDA (Devices) · 2026-09-30
Same hazard · endotoxin
See all →- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Craniotomy Kits Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- SevereMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- HighMedline Neurosurgical Kits Recalled for Endotoxin Contamination
FDA (Devices) · 2026-09-02
- HighMedline Surgical Procedure Kits Recalled Due to Sterility Concerns
FDA (Devices) · 2025-01-08
- HighMedline Medical Convenience Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- HighMedline Neurosponge Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- HighMedline Custom Surgical Procedure Kits Recalled for Potential Endotoxin Contamination
FDA (Devices) · 2025-01-08
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30