[pending] Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY P
Pending LLM rewrite. Source: FDA_DEVICE Z-0183-2026.
What this means for you
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: Pending LLM scoring against the rubric.
Plain-English summary
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
The recalled product
- Product
- Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 SFLM54AB LAMINECTOMY PACK - 219659 UDLM94AA LAMINECTOMY PACK - 206064 UILM77AU LAMINECTOMY (PS 039500) UINR44P NEURO IR PERIPHERAL
- Manufacturer
- American Contract Systems Inc.
- Category
- Medical Device — Devices
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 (10)
- ANLM40AG UDI-DI 191072232076 Lot 8192111 Bag serial number 68195596
- ANPP15AR UDI-DI 191072214423 Lot 8024911 Bag serial number 68055493
- HSLM53AB UDI-DI 191072224095 Lot 8061111 Bag serial number 68138767
- MILM82A UDI-DI 191072231512 Lot 8361111 Bag serial number 68576542
- RCNA47B UDI-DI 191072228536 Lot 8441711 Bag serial number 68680026
- SFLM54AB UDI-DI 191072217400 lot 8105511 Bag serial number N/A
- UDLM94AA UDI-DI 191072214089 Lot 8382011 Bag serial number 17621919
- UILM77AU UDI-DI 191072210333 Lot 8056311 Bag serial number N/A
- UINR44P UDI-DI 191072210340 Lot 8067511 Bag serial numbers 68138618 68140374
- then whole lot is affected
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27
- ModerateMedtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27
- HighOncology Kit With Extension Sets May Leak During Infusion Therapy
FDA (Devices) · 2026-05-27
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27