CLASS II Device recall · Reported 11 Mar 2015 · FDA Enforcement Report

The I-Cart is used to store, transport recalled by Richard Wolf Medical

Richard Wolf Medical Instruments is recalling The I-Cart is used to store, transport, and power video equipment used in medical, distributed nationwide in the US. The recall was initiated on 10 Dec 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes(NOTE: The listed serial numbers are for the carts manufactured and include those that were distributed.) 1) Part Number: 31113.801; Serial Numbers: 1306000, 1306007, 1306014, 1306021, 1306103, 1306001, 1306008, 1306015, 1306022, 1306104, 1306002, 1306009, 1306016, 1306023, 1306105, 1306003, 1306010, 1306017, 1306024, 1307100, 1306004, 1306011, 1306018, 1306100, 1307101, 1306005, 1306012, 1306019, 1306101, 1307102, 1306006, 1306013, 1306020, 1306102, 1317103. 2) Part Number: 31113.701; Serial Numbers: 11001, 11011, 11020, 11030, 11039, 11048, 11058, 11002, 11012, 11021, 11031, 11040, 11049, 11059, 11003, 11013, 11023, 11032, 11041, 11050, 11060, 11005, 11014, 11024, 11033, 11042, 11051, 11061, 11006, 11015, 11025, 11034, 11043, 11052, 11063, 11007, 11016, 11026, 11035, 11044, 11053, 11064, 11008, 11017, 11027, 11036, 11045, 11055, 11065, 11009, 11018, 11028, 11037, 11046, 11056, 11066, 11010, 11019, 11029, 11038, 11047, 11057, 11067.
Quantity recalled83 carts

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1240-2015
FDA event ID
70220
Recalling firm
Richard Wolf Medical Instruments, Vernon Hills, IL
Classification
Class II
Status
Terminated
Recall initiated
10 Dec 2014
FDA classified
3 Mar 2015
Reported
11 Mar 2015
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Foreign Material

Timeline

10 Dec 2014Recall initiated by company
3 Mar 2015Classified by FDA+83 days
11 Mar 2015Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The transformers installed on carts used for Richard Wolf medical video systems may overheat causing smoke and black plastic material to leak from the cart chassis.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

The I-Cart is used to store, transport, and power video equipment used in medical procedures.

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Why was it recalled?

The transformers installed on carts used for Richard Wolf medical video systems may overheat causing smoke and black plastic material to leak from the cart chassis.

Which lots are affected?

(NOTE: The listed serial numbers are for the carts manufactured and include those that were distributed.) 1) Part Number: 31113.801; Serial Numbers: 1306000, 1306007, 1306014, 1306021, 1306103, 1306001, 1306008, 1306015, 1306022, 1306104, 1306002, 1306009, 1306016, 1306023, 1306105, 1306003, 1306010, 1306017, 1306024, 1307100, 1306004, 1306011, 1306018, 1306100, 1307101, 1306005, 1306012, 1306019, 1306101, 1307102, 1306006, 1306013, 1306020, 1306102, 1317103. 2) Part Number: 31113.701; Serial Numbers: 11001, 11011, 11020, 11030, 11039, 11048, 11058, 11002, 11012, 11021, 11031, 11040, 11049, 11059, 11003, 11013, 11023, 11032, 11041, 11050, 11060, 11005, 11014, 11024, 11033, 11042, 11051, 11061, 11006, 11015, 11025, 11034, 11043, 11052, 11063, 11007, 11016, 11026, 11035, 11044, 11053, 11064, 11008, 11017, 11027, 11036, 11045, 11055, 11065, 11009, 11018, 11028, 11037, 11046, 11056, 11066, 11010, 11019, 11029, 11038, 11047, 11057, 11067.

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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