Affinity 4 Birthing Bed, Product Codes P3700E100429… recallZ-1816-2025 · Baxter Healthcare Corporation · initiated May 6, 2025
Class II Open, Classified All recalls posted in May 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
FDA root cause category: Nonconforming Material/Component
What the company is doing
An URGENT MEDICAL DEVICE CORRECTION notification letter dated 5/6/25 was sent to customers. Actions to be Taken by Customers 1. Customers may continue to use the potentially impacted beds until an inspection/correction has been performed by Baxter. 2. If you received this communication directly from Baxter, acknowledge receipt by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 3. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 4. Please forward a copy of this communication to the Medical Director/Office Manager, Biomedical Engineering, OB/GYN Unit Director/Manager, Director of Pharmacy, Risk Manager, Purchasing Director/Head of Central Supply and any other departments within your institution who use the affected product. 5. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures and check the associated box on the customer portal. Further Information and Support For general questions regarding this communication, please contact Baxter Technical Support at 800-445-3720 (press option 2, then option 1) between the hours of 8:00 am and 6:00 pm Central Time, Monday through Friday.
Recall details
- Recall number
- Z-1816-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- May 6, 2025
- Posted by the FDA
- May 23, 2025
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 164 units
- Product code
- KNC
- Distribution
- Worldwide distribution - US Nationwide and the countries of BAHRAIN, Canada, Chile, FRANCE, KUWAIT, NETHERLANDS, NORWAY, UNITED ARAB EMIRATES.
Product description
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P3700E100450, P3700E100453, P3700E100455, P3700E100456, P3700E100457, P3700E100459, P3700E100463, P3700E100468, P3700E100472, P3700E100476, and P3700E100477
Code information (models, lots, serial numbers)
Show the full code information (7k characters)
UDI-DI: 00887761000896; 1) P3700E100429,Serial Number: A008AA9216; 2) P3700E100429,Serial Number: A008AA9217; 3) P3700E100429,Serial Number: A009AA9218; 4) P3700E100429,Serial Number: A009AA9219; 5) P3700E100429,Serial Number: A009AA9220; 6) P3700E100429,Serial Number: A031AA9361; 7) P3700E100429,Serial Number: A031AA9362; 8) P3700E100429,Serial Number: A042AA9428; 9) P3700E100429,Serial Number: Z352AA9154; 10) P3700E100429,Serial Number: Z352AA9155; 11) P3700E100429,Serial Number: Z353AA9169; 12) P3700E100429,Serial Number: Z354AA9172; 13) P3700E100429,Serial Number: Z354AA9173; 14) P3700E100429,Serial Number: Z354AA9175; 15) P3700E100429,Serial Number: Z354AA9177; 16) P3700E100432,Serial Number: A014AA9267; 17) P3700E100433,Serial Number: A008AA9214; 18) P3700E100433,Serial Number: A015AA9274; 19) P3700E100433,Serial Number: A015AA9285; 20) P3700E100433,Serial Number: A016AA9286; 21) P3700E100433,Serial Number: A016AA9287; 22) P3700E100433,Serial Number: Z358AA9187; 23) P3700E100434,Serial Number: Z345AA9079; 24) P3700E100434,Serial Number: Z345AA9080; 25) P3700E100434,Serial Number: Z345AA9081; 26) P3700E100434,Serial Number: Z346AA9088; 27) P3700E100434,Serial Number: Z346AA9089; 28) P3700E100434,Serial Number: Z346AA9090; 29) P3700E100434,Serial Number: Z346AA9091; 30) P3700E100434,Serial Number: Z346AA9098; 31) P3700E100434,Serial Number: Z347AA9112; 32) P3700E100434,Serial Number: Z348AA9120; 33) P3700E100434,Serial Number: Z348AA9121; 34) P3700E100434,Serial Number: Z348AA9122; 35) P3700E100434,Serial Number: Z348AA9123; 36) P3700E100434,Serial Number: Z348AA9124; 37) P3700E100434,Serial Number: Z348AA9125; 38) P3700E100435,Serial Number: A008AA9206; 39) P3700E100435,Serial Number: A009AA9222; 40) P3700E100435,Serial Number: A015AA9273; 41) P3700E100435,Serial Number: A034AA9371; 42) P3700E100435,Serial Number: A034AA9375; 43) P3700E100435,Serial Number: Z345AA9071; 44) P3700E100435,Serial Number: Z345AA9072; 45) P3700E100435,Serial Number: Z345AA9073; 46) P3700E100435,Serial Number: Z345AA9074; 47) P3700E100435,Serial Number: Z345AA9075; 48) P3700E100435,Serial Number: Z345AA9076; 49) P3700E100435,Serial Number: Z345AA9077; 50) P3700E100435,Serial Number: Z345AA9078; 51) P3700E100435,Serial Number: Z345AA9082; 52) P3700E100435,Serial Number: Z345AA9083; 53) P3700E100435,Serial Number: Z345AA9084; 54) P3700E100435,Serial Number: Z345AA9085; 55) P3700E100435,Serial Number: Z346AA9086; 56) P3700E100435,Serial Number: Z346AA9087; 57) P3700E100435,Serial Number: Z346AA9099; 58) P3700E100435,Serial Number: Z346AA9100; 59) P3700E100436,Serial Number: A008AA9207; 60) P3700E100436,Serial Number: A036AA9390; 61) P3700E100436,Serial Number: Z347AA9101; 62) P3700E100436,Serial Number: Z347AA9102; 63) P3700E100437,Serial Number: A035AA9388; 64) P3700E100437,Serial Number: A035AA9389; 65) P3700E100437,Serial Number: A036AA9392; 66) P3700E100437,Serial Number: A036AA9393; 67) P3700E100437,Serial Number: A036AA9394; 68) P3700E100437,Serial Number: A036AA9397; 69) P3700E100437,Serial Number: A036AA9398; 70) P3700E100437,Serial Number: A036AA9399; 71) P3700E100437,Serial Number: A036AA9400; 72) P3700E100437,Serial Number: A037AA9404; 73) P3700E100437,Serial Number: A037AA9410; 74) P3700E100437,Serial Number: A037AA9411; 75) P3700E100437,Serial Number: A037AA9412; 76) P3700E100437,Serial Number: A037AA9413; 77) P3700E100437,Serial Number: A041AA9421; 78) P3700E100437,Serial Number: A041AA9423; 79) P3700E100437,Serial Number: A041AA9425; 80) P3700E100438,Serial Number: A013AA9258; 81) P3700E100438,Serial Number: A013AA9259; 82) P3700E100438,Serial Number: A014AA9260; 83) P3700E100438,Serial Number: A014AA9261; 84) P3700E100438,Serial Number: A014AA9262; 85) P3700E100438,Serial Number: A031AA9359; 86) P3700E100438,Serial Number: A031AA9360; 87) P3700E100438,Serial Number: A031AA9363; 88) P3700E100439,Serial Number: Z353AA9165; 89) P3700E100441,Serial Number: A014AA9271; 90) P3700E100441,Serial Number: A014AA9272; 91) P3700E100441,Serial Number: Z346AA9092; 92) P3700E100441,Serial Number: Z346AA9093; 93) P3700E100442,Serial Number: A037AA9405; 94) P3700E100442,Serial Number: A041AA9416; 95) P3700E100442,Serial Number: A041AA9417; 96) P3700E100442,Serial Number: Z354AA9174; 97) P3700E100443,Serial Number: Z352AA9157; 98) P3700E100443,Serial Number: Z353AA9158; 99) P3700E100443,Serial Number: Z353AA9159; 100) P3700E100443,Serial Number: Z353AA9161; 101) P3700E100444,Serial Number: Z346AA9094; 102) P3700E100444,Serial Number: Z346AA9095; 103) P3700E100445,Serial Number: Z347AA9113; 104) P3700E100445,Serial Number: Z347AA9114; 105) P3700E100445,Serial Number: Z347AA9115; 106) P3700E100446,Serial Number: A034AA9370; 107) P3700E100446,Serial Number: Z352AA9144; 108) P3700E100446,Serial Number: Z352AA9148; 109) P3700E100446,Serial Number: Z352AA9149; 110) P3700E100446,Serial Number: Z352AA9150; 111) P3700E100446,Serial Number: Z353AA9166; 112) P3700E100446,Serial Number: Z353AA9167; 113) P3700E100446,Serial Number: Z354AA9176; 114) P3700E100448,Serial Number: A035AA9386; 115) P3700E100448,Serial Number: Z346AA9096; 116) P3700E100449,Serial Number: Z348AA9116; 117) P3700E100449,Serial Number: Z348AA9117; 118) P3700E100449,Serial Number: Z348AA9118; 119) P3700E100449,Serial Number: Z348AA9119; 120) P3700E100450,Serial Number: Z351AA9130; 121) P3700E100453,Serial Number: Z347AA9104; 122) P3700E100453,Serial Number: Z347AA9105; 123) P3700E100453,Serial Number: Z347AA9106; 124) P3700E100453,Serial Number: Z347AA9109; 125) P3700E100455,Serial Number: Z351AA9135; 126) P3700E100455,Serial Number: Z351AA9136; 127) P3700E100455,Serial Number: Z351AA9137; 128) P3700E100456,Serial Number: Z347AA9103; 129) P3700E100456,Serial Number: Z347AA9107; 130) P3700E100456,Serial Number: Z347AA9108; 131) P3700E100456,Serial Number: Z353AA9168; 132) P3700E100457,Serial Number: Z347AA9110; 133) P3700E100457,Serial Number: Z347AA9111; 134) P3700E100459,Serial Number: Z354AA9178; 135) P3700E100459,Serial Number: Z355AA9179; 136) P3700E100459,Serial Number: Z355AA9180; 137) P3700E100463,Serial Number: Z346AA9097; 138) P3700E100468,Serial Number: A010AA9245; 139) P3700E100468,Serial Number: A013AA9246; 140) P3700E100468,Serial Number: A013AA9247; 141) P3700E100468,Serial Number: A016AA9295; 142) P3700E100468,Serial Number: A016AA9296; 143) P3700E100468,Serial Number: A016AA9298; 144) P3700E100468,Serial Number: A027AA9305; 145) P3700E100468,Serial Number: A035AA9382; 146) P3700E100472,Serial Number: A031AA9357; 147) P3700E100472,Serial Number: A031AA9358; 148) P3700E100476,Serial Number: A031AA9355; 149) P3700E100476,Serial Number: A031AA9356; 150) P3700E100476,Serial Number: A035AA9378; 151) P3700E100476,Serial Number: A035AA9379; 152) P3700E100476,Serial Number: A035AA9380; 153) P3700E100476,Serial Number: A035AA9383; 154) P3700E100476,Serial Number: A035AA9387; 155) P3700E100476,Serial Number: A036AA9402; 156) P3700E100476,Serial Number: A037AA9406; 157) P3700E100476,Serial Number: A037AA9408; 158) P3700E100476,Serial Number: A037AA9414; 159) P3700E100476,Serial Number: A037AA9415; 160) P3700E100477,Serial Number: A042AA9433; 161) P3700E100477,Serial Number: A042AA9435; 162) P3700E100477,Serial Number: A042AA9436; 163) P3700E100477,Serial Number: A042AA9437; 164) P3700E100477,Serial Number: A042AA9438
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Affinity® 4 Birthing Bed P3700EHill-Rom, Inc. · TABLE, OBSTETRIC (AND ACCESSORIES)1 recall255 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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