Lone Star Medical Products

Stafford, TX, US

Lone Star Medical Products appears in FDA device records in Stafford, TX. FDA records list 6 510(k) clearances between 1979-09-19 and 1985-02-21, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 4 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 6
PMA records: 0
Recall records: 4
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Lone Star Medical Products carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

CooperSurgical, Inc. D.B.A. Lone Star Medical Productsenforcement report, recall

510(k) clearance history

FDA records hold 6 510(k) clearances for Lone Star Medical Products between 1979 and 1985. The busiest year on record is 1979, with 1. The most recent is 1985, with 1.

Clearances by year, as a table

510(k) clearance decisions for Lone Star Medical Products, by decision year
Year	Clearances
1979	1
1980	1
1981	1
1982	1
1984	1
1985	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K850041	P-3 CLOSING INSTRUMENT		Substantially Equivalent	1985-02-21
K831531	SURGICAL ISOLATION BARRIER SYSTEM		Substantially Equivalent	1984-06-05
K820015	URETHAL CUTTER CLAMP	KOA	Substantially Equivalent	1982-02-22
K810915	THE SCOTT DIALMENZENSERT	KOA	Substantially Equivalent	1981-05-08
K802983	THE INQUINAL RESORVOIR INSERTER	KOA	Substantially Equivalent	1980-12-30
K791665	SCOTTS SURGICAL RETRACTOR AND ELASTIC	GAD	Substantially Equivalent	1979-09-19

Registered establishments

FDA registered establishments for Lone Star Medical Products, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1627186	1627186	Lone Star Medical Products	11211 Cash Rd, Stafford, TX 77477 US	2026	DRC GAD HEW KOA LKF

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0147-2015	Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.	CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper.	Class II	2013-09-13	Terminated
Z-0214-2007	Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, model #1110; manufactured by Lone Star Medical Products, Inc.	Ni-Cr Plated 1100 Series Retractors with a chromium finish were replaced by Retractors with a hard-anodized finish after complaints of peeling were received.		2004-10-06	Terminated
Z-0213-2007	Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1107; manufactured by Lone Star Medical Products, Inc.	Ni-Cr Plated 1100 Series Retractors with a chromium finish were replaced by Retractors with a hard-anodized finish after complaints of peeling were received.		2004-10-06	Terminated
Z-0212-2007	Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1104; manufactured by Lone Star Medical Products, Inc.	Ni-Cr Plated 1100 Series Retractors with a chromium finish were replaced by Retractors with a hard-anodized finish after complaints of peeling were received.		2004-10-06	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain