Home › Automated Medical Products Corp. › II Ring Retractor

II Ring Retractor

Automated Medical Products Corp. · Model Pelvic Surgery System w 1x4" Maleable Blades · UDI-DI 00810118343100

GAD Prescription

510(k) clearances

1,671

Adverse events (4 deaths)

Recalls

666

Facilities

Description

Pelvic Surgical Retractor System ; Vaginal Surgical Retractor System 50-4692 with 1"x4" Malleable blades Table Post 12", 1" Post Coupling, Horizontal Flex Bar, 6 Tilt Ratchet Mechanisms, Vaginal Segmented Ring 9.5" x 13.5" Retractors: Lateral Vaginal 1" x 3", Vaginal Posterior 1" x 4.5", Deaver Small 1" x 3.5", Deaver Large 1" x 5" 2 Malleable 1" x 4" with protected edge, 2 Super Malleable 1" x 4" with protected edge

Recalls

Date	Firm	Reason
2026-06-05	Integra LifeSciences Corp. (NeuroSciences)	The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110
2025-04-09	MEDLINE INDUSTRIES, LP - Northfield	Three is the potential for the retractors to puncture through the sterile packaging.
2024-12-03	Sklar Instruments	Reports of various packaging issues that may result in a breach of the sterile barrier.
2024-05-17	SEASPINE ORTHOPEDICS CORPORATION	Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
2024-05-17	SEASPINE ORTHOPEDICS CORPORATION	Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
2024-02-23	MEDLINE INDUSTRIES, LP - Northfield	Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
2023-12-21	Medagent Inc	Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which
2023-05-25	TELEFLEX LLC	There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
2023-05-25	TELEFLEX LLC	There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
2022-12-08	Medtronic Navigation, Inc.	Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.