Use cautionMedical device recall · FDA · Published June 28, 2018
Bayer OCS Support Systems Recall: Risk of Injury from Overtightened Bolts
Bayer Medical Care recalls overhead counterpo: OCS CONF models with potential bolt overtightening that could cause system disengagement and injury. Affected units have specific serial numbers and catalog codes.
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.
Take action
Contact the company
📍Recalling firmBayer Medical Care, Inc.1 Bayer Dr · Indianola, PA 15051-9702
✎ GovInfoNow plain-language explainer
Bayer Medical Care is recalling overhead counterpoise systems (OCS) that may have been overtightened during service, risking disengagement from ceiling mounts and potential injury to patients or operators. This recall affects specific models with known serial numbers and catalog codes. Read more at govinfonow.com/recall/70702-bayer-ocs-support-systems-recall-risk-of-injury-from-overtightened.
“Bayer OCS Support Systems Recall: Risk of Injury from Overtightened Bolts.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70702-bayer-ocs-support-systems-recall-risk-of-injury-from-overtightened. Based on FDA recall #Z-2961-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2961-2018%22&limit=1).
Bayer Medical Care, Inc. recalled Overhead Counterpoise Systems (OCS) OCS CONF accessory devices on June 28, 2018, according to the FDA. The torque wrench used during service was outside specification, potentially compromising structural integrity and causing the device to disengage from its ceiling mount.
How to tell if you have it
Brand: Bayer Medical Care
Product: Overhead Counterpoise Systems (OCS) OCS CONF
Catalog #: OCS 115AS
Material Number: 59880288
Serial Number: 4061630901
Sold in: OH, TX, WV
The hazard
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.
Context
GovInfoNow's records show Bayer Medical Care, Inc. has had 7 other recalls on record since Sept. 7, 2018. Other recent recalls of similar products include Bayer Stellant FLEX Syringe Kit Recall (July 31, 2026), Bayer Avanta Tube Sets (April 24, 2026), and Bayer Source Administration Set Recall (Nov. 30, 2022). Other recent recalls of similar products include Canon Alphenix X-ray Systems Recall (Aug. 4, 2026), Canon Alphenix INFX-8000C X-ray System Recall (Dec. 19, 2025), and Canon Alphenix INFX-8000H X-ray System Recall (Dec. 19, 2025).
How to tell if you have this one
Check for the catalog number OCS 115AS and serial number 4061630901 on the device. The OCS CONF model is used with Bayer injector systems as a support for an injector head.
Brand
Bayer Medical Care
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
The devices were distributed to the following US states: OH, TX, and WV.
Recall number
Product, codes & lots
Quantity
Z-2960-2018
Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253; Serial Numbers: 11051103902, 305746202
2
Z-2961-2018
Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material Number 59880288; Serial Number: 4061630901
1
Z-2962-2018
Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765; Serial Numbers: 917/21956, 516/21035, 817/21916, 817/21910
4
Based on the official FDA remedy
What to do — step by step
Check Device Details
Look for catalog number OCS 115AS and serial number 4061630901 on the device.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “The devices were distributed to the following US states: OH, TX, and WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Ohio, Texas, West Virginia.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2961-2018 (June 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2961-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.