Pro-Dex Inc FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaClass IISep 23, 2024The packaging of a sterile battery, intended to power a surg	The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings insid	Class IIDevices	Sep 23, 2024
KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDClass IIFeb 15, 2023Battery packs used in surgical procedures where a surgeon us	Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachm	Class IIDevices	Feb 15, 2023
KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (eClass IIFeb 14, 2023Incorrect Unique Device Identifier/GTIN code was used on pro	Incorrect Unique Device Identifier/GTIN code was used on product.	Class IIDevices	Feb 14, 2023