Facility

APPLIED MEDICAL RESOURCES CORP.

15 recall(s) on record — most severe on record: Class I.

Key facts

15recalls · worst Class I

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	2027111
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	22872 AVENIDA EMPRESA RSM, CA, US 92688
Registration status	Active · expires 2026
Parent company	APPLIED MEDICAL RESOURCES (owner-operator 2027111)

Activity by year

Recalls (15)
Inspections (3)

Devices registered here (1)

Clamp, Vascular
Product code DXC (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.4450

Recalls & enforcement

20251 record

Class IIOngoing2025-12-11
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.

20241 record

Class IIOngoing2024-01-30
Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.

20202 records

Class IITerminated2020-03-17
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
Class IITerminated2020-01-31
Failure of cardiovascular clips to provide sufficient occlusion of the vessel.

20192 records

Class ITerminated2019-10-24
The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.
Class IITerminated2019-01-28
The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.

20181 record

Class IITerminated2018-12-12
Unintentional shifting of the tip insulation of the firm's electrosurgical probes.

20171 record

Class IITerminated2017-05-04
Due to possibility of insufficient sterilization.

20161 record

Class IITerminated2016-04-01
Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.

20152 records

Class IITerminated2015-12-22
Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanis…
Class IITerminated2015-07-31
Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.

20132 records

Class IITerminated2013-10-21
Applied Medical is conducting a voluntary recall of the Inzii® 12/15mm retrieval system. During shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. The likelihood of this situation to occur a…
Class IITerminated2013-05-01
Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix® and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger to fracture and the jaws to remain in th…

20122 records

Class IITerminated2012-11-05
Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The a…
Class IITerminated2012-08-09
Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.

FDA inspections (3)

NAI2021-09-02
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2018-11-20
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2017-03-31
Voluntary Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “APPLIED MEDICAL RESOURCES CORP. (FEI 2027111) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2027111-applied-medical-resources-corp/

Not open yet

Alerts for APPLIED MEDICAL RESOURCES CORP.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.