Firefly Medical Recalls IVEA 500A Medical Beds Due to Dowel Pin Defect
Firefly Medical is recalling 239 IVEA 500A medical beds because a dowel pin could slip out, causing the bed to slump and potentially making a patient stumble.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (patient stumbling) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Firefly Medical, Inc. is recalling 239 units of the IVEA 500A medical bed, intended for Med-Surg patient care. The recall was initiated because a dowel pin in the product could potentially slip out of its press fit. This defect could result in the product slumping to one side, which could cause a patient to stumble.
The affected units are identified by Product Part Number 16100 and Serial Numbers 100200-101068, excluding serial numbers within this range that were not released into final inventory for other reasons. The products were distributed worldwide, including in the USA and Canada.
The recalled product
- Product
- IVEA 500A Intended for Med-Surg patient care.
- Manufacturer
- Firefly Medical, Inc.
- Category
- Medical Device — Hospital Bed
- Affected units
- 239
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product Part Number 16100. Serial Numbers 100200-101068
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Firefly Medical, Inc.
See all →- HighFirefly Medical Recalls IVEA Product Part Number 16100 Model 500A
FDA (Devices) · 2017-10-11
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- HighFirefly Medical Recalls IVEA Product Part Number 16100 Model 500A
FDA (Devices) · 2017-10-11
- HighPhilips EasyDiagnost Eleva DRF Footplate Recall for Injury Risk
FDA (Devices) · 2018-08-29
- HighPhilips EasyDiagnost Eleva DRF Footplate Hook Recall
FDA (Devices) · 2018-08-29
- HighStryker S3 MedSurg Bed Fowler Control Failure Recall
FDA (Devices) · 2016-08-17
- SevereHill-Rom Recalls 1,033 Centralia Smart+ Beds Due to Screw Defect
FDA (Devices) · 2020-08-05
- SeverePhilips Allura Centron patient table mattress defect poses fall risk
FDA (Devices) · 2025-02-26