Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS
FDA Device Recall #Z-1239-2022 — Class II — April 21, 2022
Recall Summary
| Recall Number | Z-1239-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 21, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Oakworks Inc |
| Location | New Freedom, PA |
| Product Type | Devices |
| Quantity | 109 |
Product Description
Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS
Reason for Recall
The warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.
Distribution Pattern
US Nationwide distribution in the states of MA, NJ, and PA.
Lot / Code Information
UDI-DI: n/a Serial Numbers: PWK769356 PWK769357 PWK769358 PWK769359 PWK769360 PWK769361 PWK769362 PWK769363 PWK769364 PWK769365 PWK769366 PWK769367 PWK769368 PWK769369 PWK769370 PWK769371 PWK769372 PWK769373 PWK769374 PWK769375 PWK769376 PWK769377 PWK769378 PWK769379 PWK769380 PWK769381 PWK769382 PWK769383 PWK769384 PWK769385 PWK769386 PWK769387 PWK769388 PWK769389 PWK769390 PWK769391 PWK769392 PWK769393 PWK769394 PWK769395 PWK769396 PWK769397 PWK769398 PWK769399 PWK769400 PWK769401 PWK769402 PWK769403 PWK769404 PWK769405 PWK769406 PWK769407 PWK769408 PWK769409 PWK769410 PWK769411 PWK769412 PWK769413 PWK769414 PWK769415 PWK769416 PWK769417 PWK769418 PWK769419 PWK769420 PWK769421 PWK769422 PWK769423 PWK769424 PWK769425 PWK769426 PWK769427 PWK769428 PWK769429 PWK769430 PWK769431 PWK769432 PWK769433 PWK769434 PWK769435 PWK769436 PWK769437 PWK769438 PWK769439 PWK769440 PWK769441 PWK769442 PWK769443 PWK769444 PWK769445 PWK769446 PWK769447 PWK769448 PWK769449 PWK769450 PWK769451 PWK769452 PWK769453 PWK769454 PWK769455 PWK769456 PWK769457 PWK769458 PWK769459 PWK769460 PWK769461 PWK769462 PWK769463 PWK769464
Other Recalls from Oakworks Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0729-2024 | Class II | Ultrasound EA (Ergonomic Advantage) table versi... | Dec 5, 2023 |
| Z-0728-2024 | Class II | Ultrasound EA (Ergonomic Advantage) table versi... | Dec 5, 2023 |
| Z-0730-2024 | Class II | Ultrasound EA (Ergonomic Advantage) table versi... | Dec 5, 2023 |
| Z-0727-2024 | Class II | Ultrasound EA (Ergonomic Advantage) table versi... | Dec 5, 2023 |
| Z-1238-2022 | Class II | PX200 Emergency Relief Bed; Model No. PXEXEB362... | Apr 21, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.