FDA DeviceClass IINotable

FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF,

Date: 2026-05-06
Brand: Medline Industries, LP
Category: Medical Device
FDA Class: Class II

Description

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

Hazard

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

Remedy

160 kits

View original recall →
Share:

Related Recalls

2026-06-03 · FDA_DEVICE
FDA Recall: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPI
Medline Industries, LP
2026-06-03 · FDA_DEVICE
FDA Recall: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BL
Medline Industries, LP
2026-06-03 · FDA_DEVICE
FDA Recall: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOC
Medline Industries, LP
2026-06-03 · FDA_DEVICE
FDA Recall: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL
Medline Industries, LP