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ModerateClass IITerminated

FDA Devices recall · Reported December 18, 2013

Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA. Used to isolate suction waste during surgeries, or to clear patient airways, throat or wounds to allow treatment.

Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be achieved due to the canister and liner not properly seating.

Recall #
Z-0457-2014
Affected scope
3,560 units distributed from June 2004 - December 2012
Initiated
July 17, 2013
Compiled from official public sources by the editorial team.
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Hospira Inc. recalled Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS… - a moderate-severity action.

Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS… was recalled by Hospira Inc. in December 18, 2013. Reason: Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be a…. Check the official notice for the remedy. Verify recall #Z-0457-2014 with the FDA Devices before acting.

The recall

Hospira Inc. issued this moderate-severity FDA Devices recall-Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be a….

Moderate
severity level
4K units
affected scope
Class II
classification
December 18, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0457-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0457-2014) was formally reported on December 18, 2013, with the manufacturer initiating the action on July 17, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Hospira Inc. is listed as the recalling firm, operating out of Lake Forest, IL. Federal records list the affected scope as 3,560 units distributed from June 2004 - December 2012.

The documented reason for this recall is: Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be achieved due to the canister and liner not properly seating. Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NY, PA, SD, TX, UT, VA, and WA and countries of: Canada and EMEA.. 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.

Medical Devices recalls over time

Where this recall sits in its category - 40,322 medical devices recalls on record

-1,00001,0002,0003,0004,000 20052008201120142017202020232026 1,248
Severity2487872426High severity (most serious)Moderate severityLow severity
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

3,560 units distributed from June 2004 - December 2012

Related Recalls

6

3 from same agency

Product description

Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA. Used to isolate suction waste during surgeries, or to clear patient airways, throat or wounds to allow treatment.

Reason for recall

Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be achieved due to the canister and liner not properly seating.

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-0457-2014
Date reported December 18, 2013
Date initiated July 17, 2013
Recalling firm Hospira Inc.
Firm location Lake Forest, IL
Affected scope 3,560 units distributed from June 2004 - December 2012
Distribution Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NY, PA, SD, TX, UT, VA, and WA and countries of: Canada and EMEA.

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

Scale of Impact

3,560 units distributed from June 2004 - December 2012 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-0457-2014) 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?
Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA. Used to isolate suction waste during surgeries, or to clear patient airways, throat or wounds to allow treatment.. Recalled by Hospira Inc.. Units affected: 3,560 units distributed from June 2004 - December 2012.
Why was this product recalled?
Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be achieved due to the canister and liner not properly seating.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 18, 2013. Severity: Moderate. Recall number: Z-0457-2014.
Where was the recalled product distributed?
Distribution: Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NY, PA, SD, TX, UT, VA, and WA and countries of: Canada and EMEA..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-0457-2014) 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 December 18, 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.