Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 12, 2018
Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtighteni…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bayer Medical Care, Inc. recalled Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS C… - a moderate-severity action.
Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS C… was recalled by Bayer Medical Care, Inc. in September 12, 2018. Reason: The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque…. Check the official notice for the remedy. Verify recall #Z-2962-2018 with the FDA Devices before acting.
The recall
Bayer Medical Care, Inc. issued this moderate-severity FDA Devices recall-The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque….
- Moderate
- severity level
- 4 units
- affected scope
- Class II
- classification
- September 12, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2962-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2962-2018) was formally reported on September 12, 2018, with the manufacturer initiating the action on June 28, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Bayer Medical Care, Inc. is listed as the recalling firm, operating out of Indianola, PA. Federal records list the affected scope as 4.
The documented reason for this recall is: The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structura… Distribution data in the federal record shows the product reached: The devices were distributed to the following US states: OH, TX, 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 - 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 - 40,422 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.
Affected scope
4
Related Recalls
6
0 from same agency
Product description
Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
Reason for recall
The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2962-2018 |
| Date reported | September 12, 2018 |
| Date initiated | June 28, 2018 |
| Recalling firm | Bayer Medical Care, Inc. |
| Firm location | Indianola, PA |
| Affected scope | 4 |
| Distribution | The devices were distributed to the following US states: OH, TX, and WV. |
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.
- Check the recall number (Z-2962-2018) 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? ▼
Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765. Recalled by Bayer Medical Care, Inc.. Units affected: 4.
Why was this product recalled? ▼
The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 12, 2018. Severity: Moderate. Recall number: Z-2962-2018.
Where was the recalled product distributed? ▼
Distribution: The devices were distributed to the following US states: OH, TX, and WV..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2962-2018) 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 September 12, 2018. 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.