ModerateClass IITerminated

FDA Devices recall · Reported April 24, 2013

Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on April 24, 2013. Severity: Moderate. Recall number: Z-1125-2013.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution - USA including AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. Shipped internationally to Canada, Ireland, Hong Kong, the Netherlands, New Zealand, and Thailand..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1125-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.

Recall #: Z-1125-2013
Affected scope: 2998
Initiated: September 7, 2012

Compiled from official public sources by the editorial team. · Updated August 2026

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Instrumentation Industries Inc recalled Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR a… - a moderate-severity action.

Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR a… was recalled by Instrumentation Industries Inc in April 24, 2013. Reason: Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions…. Check the official notice for the remedy. Verify recall #Z-1125-2013 with the FDA Devices before acting.

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The recall

Instrumentation Industries Inc issued this moderate-severity FDA Devices recall-Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions….

Moderate
severity level: 3K units
affected scope: Class II
classification: April 24, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1125-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1125-2013) was formally reported on April 24, 2013, with the manufacturer initiating the action on September 7, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Instrumentation Industries Inc is listed as the recalling firm, operating out of Bethel Park, PA. Federal records list the affected scope as 2998.

The documented reason for this recall is: Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

2998

Related Recalls

3 from same agency

Product description

Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions.

Reason for recall

Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1125-2013
Date reported	April 24, 2013
Date initiated	September 7, 2012
Recalling firm	Instrumentation Industries Inc
Firm location	Bethel Park, PA
Affected scope	2998
Distribution	Worldwide Distribution - USA including AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. Shipped internationa…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

2998 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1125-2013) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on April 24, 2013. Severity: Moderate. Recall number: Z-1125-2013.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution - USA including AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. Shipped internationally to Canada, Ireland, Hong Kong, the Netherlands, New Zealand, and Thailand..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1125-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 24, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.