Severity
Moderate
FDA Devices recall · Reported September 18, 2019
possibility of the sterility batch being insufficiently sterilized
Aesculap Implant Systems LLC recalled CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended… - a moderate-severity action.
CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended… was recalled by Aesculap Implant Systems LLC in September 18, 2019. Reason: possibility of the sterility batch being insufficiently sterilized. Check the official notice for the remedy. Verify recall #Z-2496-2019 with the FDA Devices before acting.
The recall
Aesculap Implant Systems LLC issued this moderate-severity FDA Devices recall-possibility of the sterility batch being insufficiently sterilized.
Sourced from official FDA Devices enforcement records. Verify recall #Z-2496-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2496-2019) was formally reported on September 18, 2019, with the manufacturer initiating the action on August 7, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Aesculap Implant Systems LLC is listed as the recalling firm, operating out of Center Valley, PA. Federal records list the affected scope as 3 unit of Lot 837B.
The documented reason for this recall is: possibility of the sterility batch being insufficiently sterilized Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of CA.. 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 its category - 40,322 medical devices recalls on record
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 unit of Lot 837B
Related Recalls
6
3 from same agency
CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
possibility of the sterility batch being insufficiently sterilized
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2496-2019 |
| Date reported | September 18, 2019 |
| Date initiated | August 7, 2019 |
| Recalling firm | Aesculap Implant Systems LLC |
| Firm location | Center Valley, PA |
| Affected scope | 3 unit of Lot 837B |
| Distribution | US Nationwide distribution in the state of CA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
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.
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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 September 18, 2019. 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.