Summary
The FDA issued a Class II for Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS by Oakworks Inc. Reason: The warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs..
Details
Source
Device Recall
External ID
Z-1239-2022
Action Date
2022-06-15
Status
Terminated
Category
device
Product Description
Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS
Lot/Code Info: 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
Quantity Affected: 109
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
US Nationwide distribution in the states of MA, NJ, and PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-21
Company
New Freedom, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 178 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Oakworks Inc has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Oakworks Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Oakworks Inc have FDA actions?
Oakworks Inc has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1239-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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