The Recall Desk
SevereFDA (Devices)·Z-1820-2015·Announced 2015-07-01

Hill-Rom Steriseal-Cannula Ophthalmic Recall Due to Dislodgement Risk

Hill-Rom is recalling Steriseal-Cannula Ophthalmic handpieces because the metal cannula can rotate and become dislodged from the plastic handpiece.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device that can cause the component to dislodge, posing a significant risk of injury during a procedure.

Plain-English summary

Hill-Rom, Inc. is recalling 66,691 units of the Steriseal-Cannula Ophthalmic Bi-Manual Irrigating/Aspirating Handpiece. The recall involves product numbers 157400, 257400, 157500, and 257500.

The recall is being issued because the metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece. This defect poses a risk of injury to patients or medical professionals during use.

The affected products were distributed worldwide, including nationwide in the United States (specifically noting Michigan and Pennsylvania) and in Belgium, England, Italy, the Czech Republic, Turkey, Greece, Ireland, Scotland, Spain, and Lebanon. Healthcare facilities and consumers should stop using the affected devices and contact Hill-Rom, Inc. for further instructions on replacement or return.

The recalled product

Product
Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
Manufacturer
Hill-Rom, Inc.
Affected units
66,691

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Product #s: 157400
  • 257400
  • 157500
  • 257500

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically: