Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.
FDA Device Recall #Z-1414-2022 — Class II — June 24, 2022
Recall Summary
| Recall Number | Z-1414-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 24, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Healthcare Corporation |
| Location | Deerfield, IL |
| Product Type | Devices |
| Quantity | 202 mattresses |
Product Description
Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.
Reason for Recall
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NM, NM, NY, OH, OK, RI, SD, TN, TX, VT, and WI. There was government distribution but no military distribution. The country of Canada.
Lot / Code Information
UDI 00887761977853; Serial numbers: W236BP4315, W236BP4320, W236BP4326, W235BP4284, W235BP4294, W236BP4318, W236BP4319, W236BP4323, W236BP4325, W236BP4331, W236BP4333, W236BP4334, W236BP4336, W235BP4270, W235BP4271, W235BP4272, W235BP4278, W235BP4279, W235BP4287, W235BP4291, W235BP4292, W235BP4299, W235BP4307, W235BP4311, W236BP4314, W236BP4321, W236BP4322, W236BP4324, W236BP4329, W236BP4335, W235BP4309, W235BP4313, W215BP3994, W215BP3995, W215BP4002, W215BP4009, W215BP4011, W214BP3979, W214BP3980, W214BP3981, W214BP3982, W214BP3983, W215BP3985, W215BP3986, W215BP3990, W215BP3992, W215BP3993, W215BP3984, W215BP3987, W215BP3988, W215BP3989, W215BP3991, W215BP3996, W215BP4001, W215BP4003, W215BP4005, W215BP4006, W235BP4282, W235BP4285, W235BP4286, W235BP4289, W235BP4293, W235BP4295, W235BP4298, W235BP4300, W235BP4301, W235BP4302, W235BP4303, W235BP4304, W235BP4305, W235BP4306, W235BP4308, W236BP4316, W236BP4317, W236BP4327, W236BP4328, W236BP4330, W236BP4337, W214BP3968, W214BP3969, W214BP3970, W214BP3971, W214BP3972, W214BP3973, W214BP3974, W214BP3975, W214BP3976, W214BP3977, W214BP3978, W215BP3997, W215BP3998, W215BP3999, W215BP4000, W215BP4004, W215BP4007, W215BP4008, W215BP4010, W215BP4012, W235BP4267, W235BP4268, W235BP4269, W235BP4273, W235BP4275, W235BP4276, W235BP4277, W235BP4283, W344BP6702, W344BP6703, W344BP6727, W344BP6728, W344BP6729, W348BP6805, W348BP6806, W348BP6807, W348BP6812, W348BP6813, W348BP6820, W348BP6821, W348BP6827, W348BP6828, W348BP6830, W344BP6688, W344BP6690, W344BP6694, W344BP6695, W344BP6706, W344BP6707, W344BP6708, W344BP6709, W344BP6710, W344BP6713, W344BP6748, W347BP6776, W347BP6777, W347BP6787, W347BP6788, W347BP6789, W348BP6809, W348BP6810, W348BP6811, W348BP6814, W348BP6815, W348BP6816, W348BP6817, W348BP6818, W348BP6819, W348BP6826, W344BP6704, W344BP6705, W344BP6749, W344BP6689, W344BP6692, W344BP6698, W344BP6700, W344BP6701, W347BP6778, W347BP6781, W347BP6782, W347BP6783, W347BP6790, W347BP6791, W347BP6792, W347BP6802, W347BP6803, W348BP6823, W348BP6825, X048BP7395, X048BP7382, X048BP7383, X048BP7385, X048BP7386, X048BP7387, X048BP7388, X048BP7392, X048BP7394, X048BP7396, X048BP7397, X049BP7411, X049BP7412, X049BP7414, X049BP7415, X049BP7416, X049BP7418, X049BP7419, X049BP7420, X049BP7421, X049BP7422, X049BP7423, X049BP7424, X049BP7425, X055BP7466, X055BP7467, X055BP7469, X055BP7471, X055BP7473, X055BP7475, X055BP7476, X055BP7477, W348BP6824, W348BP6831, X048BP7384, and X048BP7391.
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| Z-1368-2026 | Class II | Brand Name: Spectrum IQ Product Name: Infusion... | Jan 13, 2026 |
| Z-1121-2026 | Class II | SIGMA Spectrum Infusion Pump, Model/Catalog Num... | Nov 28, 2025 |
| Z-0847-2026 | Class II | Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalo... | Oct 28, 2025 |
| Z-0233-2026 | Class II | Oral Probe (Product code 02893-000), accessory ... | Sep 17, 2025 |
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.