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RecallWatchMedical Device Safety
Class IIOngoingZ-1816-2025

Baxter Healthcare Corporation recalls Affinity 4 Birthing Bed

Baxter Healthcare CorporationDeerfield, IL, United StatesReported Jun 4, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

UDI
00887761000896; 1) P3700E100429
Serial #
A008AA9216; 2) P3700E100429
Serial #
A008AA9217; 3) P3700E100429
Serial #
A009AA9218; 4) P3700E100429
Serial #
A009AA9219; 5) P3700E100429
Serial #
A009AA9220; 6) P3700E100429
Serial #
A031AA9361; 7) P3700E100429
Serial #
A031AA9362; 8) P3700E100429
Serial #
A042AA9428; 9) P3700E100429
Serial #
Z352AA9154; 10) P3700E100429
Show 155 more code fields
Serial #
Z352AA9155; 11) P3700E100429
Serial #
Z353AA9169; 12) P3700E100429
Serial #
Z354AA9172; 13) P3700E100429
Serial #
Z354AA9173; 14) P3700E100429
Serial #
Z354AA9175; 15) P3700E100429
Serial #
Z354AA9177; 16) P3700E100432
Serial #
A014AA9267; 17) P3700E100433
Serial #
A008AA9214; 18) P3700E100433
Serial #
A015AA9274; 19) P3700E100433
Serial #
A015AA9285; 20) P3700E100433
Serial #
A016AA9286; 21) P3700E100433
Serial #
A016AA9287; 22) P3700E100433
Serial #
Z358AA9187; 23) P3700E100434
Serial #
Z345AA9079; 24) P3700E100434
Serial #
Z345AA9080; 25) P3700E100434
Serial #
Z345AA9081; 26) P3700E100434
Serial #
Z346AA9088; 27) P3700E100434
Serial #
Z346AA9089; 28) P3700E100434
Serial #
Z346AA9090; 29) P3700E100434
Serial #
Z346AA9091; 30) P3700E100434
Serial #
Z346AA9098; 31) P3700E100434
Serial #
Z347AA9112; 32) P3700E100434
Serial #
Z348AA9120; 33) P3700E100434
Serial #
Z348AA9121; 34) P3700E100434
Serial #
Z348AA9122; 35) P3700E100434
Serial #
Z348AA9123; 36) P3700E100434
Serial #
Z348AA9124; 37) P3700E100434
Serial #
Z348AA9125; 38) P3700E100435
Serial #
A008AA9206; 39) P3700E100435
Serial #
A009AA9222; 40) P3700E100435
Serial #
A015AA9273; 41) P3700E100435
Serial #
A034AA9371; 42) P3700E100435
Serial #
A034AA9375; 43) P3700E100435
Serial #
Z345AA9071; 44) P3700E100435
Serial #
Z345AA9072; 45) P3700E100435
Serial #
Z345AA9073; 46) P3700E100435
Serial #
Z345AA9074; 47) P3700E100435
Serial #
Z345AA9075; 48) P3700E100435
Serial #
Z345AA9076; 49) P3700E100435
Serial #
Z345AA9077; 50) P3700E100435
Serial #
Z345AA9078; 51) P3700E100435
Serial #
Z345AA9082; 52) P3700E100435
Serial #
Z345AA9083; 53) P3700E100435
Serial #
Z345AA9084; 54) P3700E100435
Serial #
Z345AA9085; 55) P3700E100435
Serial #
Z346AA9086; 56) P3700E100435
Serial #
Z346AA9087; 57) P3700E100435
Serial #
Z346AA9099; 58) P3700E100435
Serial #
Z346AA9100; 59) P3700E100436
Serial #
A008AA9207; 60) P3700E100436
Serial #
A036AA9390; 61) P3700E100436
Serial #
Z347AA9101; 62) P3700E100436
Serial #
Z347AA9102; 63) P3700E100437
Serial #
A035AA9388; 64) P3700E100437
Serial #
A035AA9389; 65) P3700E100437
Serial #
A036AA9392; 66) P3700E100437
Serial #
A036AA9393; 67) P3700E100437
Serial #
A036AA9394; 68) P3700E100437
Serial #
A036AA9397; 69) P3700E100437
Serial #
A036AA9398; 70) P3700E100437
Serial #
A036AA9399; 71) P3700E100437
Serial #
A036AA9400; 72) P3700E100437
Serial #
A037AA9404; 73) P3700E100437
Serial #
A037AA9410; 74) P3700E100437
Serial #
A037AA9411; 75) P3700E100437
Serial #
A037AA9412; 76) P3700E100437
Serial #
A037AA9413; 77) P3700E100437
Serial #
A041AA9421; 78) P3700E100437
Serial #
A041AA9423; 79) P3700E100437
Serial #
A041AA9425; 80) P3700E100438
Serial #
A013AA9258; 81) P3700E100438
Serial #
A013AA9259; 82) P3700E100438
Serial #
A014AA9260; 83) P3700E100438
Serial #
A014AA9261; 84) P3700E100438
Serial #
A014AA9262; 85) P3700E100438
Serial #
A031AA9359; 86) P3700E100438
Serial #
A031AA9360; 87) P3700E100438
Serial #
A031AA9363; 88) P3700E100439
Serial #
Z353AA9165; 89) P3700E100441
Serial #
A014AA9271; 90) P3700E100441
Serial #
A014AA9272; 91) P3700E100441
Serial #
Z346AA9092; 92) P3700E100441
Serial #
Z346AA9093; 93) P3700E100442
Serial #
A037AA9405; 94) P3700E100442
Serial #
A041AA9416; 95) P3700E100442
Serial #
A041AA9417; 96) P3700E100442
Serial #
Z354AA9174; 97) P3700E100443
Serial #
Z352AA9157; 98) P3700E100443
Serial #
Z353AA9158; 99) P3700E100443
Serial #
Z353AA9159; 100) P3700E100443
Serial #
Z353AA9161; 101) P3700E100444
Serial #
Z346AA9094; 102) P3700E100444
Serial #
Z346AA9095; 103) P3700E100445
Serial #
Z347AA9113; 104) P3700E100445
Serial #
Z347AA9114; 105) P3700E100445
Serial #
Z347AA9115; 106) P3700E100446
Serial #
A034AA9370; 107) P3700E100446
Serial #
Z352AA9144; 108) P3700E100446
Serial #
Z352AA9148; 109) P3700E100446
Serial #
Z352AA9149; 110) P3700E100446
Serial #
Z352AA9150; 111) P3700E100446
Serial #
Z353AA9166; 112) P3700E100446
Serial #
Z353AA9167; 113) P3700E100446
Serial #
Z354AA9176; 114) P3700E100448
Serial #
A035AA9386; 115) P3700E100448
Serial #
Z346AA9096; 116) P3700E100449
Serial #
Z348AA9116; 117) P3700E100449
Serial #
Z348AA9117; 118) P3700E100449
Serial #
Z348AA9118; 119) P3700E100449
Serial #
Z348AA9119; 120) P3700E100450
Serial #
Z351AA9130; 121) P3700E100453
Serial #
Z347AA9104; 122) P3700E100453
Serial #
Z347AA9105; 123) P3700E100453
Serial #
Z347AA9106; 124) P3700E100453
Serial #
Z347AA9109; 125) P3700E100455
Serial #
Z351AA9135; 126) P3700E100455
Serial #
Z351AA9136; 127) P3700E100455
Serial #
Z351AA9137; 128) P3700E100456
Serial #
Z347AA9103; 129) P3700E100456
Serial #
Z347AA9107; 130) P3700E100456
Serial #
Z347AA9108; 131) P3700E100456
Serial #
Z353AA9168; 132) P3700E100457
Serial #
Z347AA9110; 133) P3700E100457
Serial #
Z347AA9111; 134) P3700E100459
Serial #
Z354AA9178; 135) P3700E100459
Serial #
Z355AA9179; 136) P3700E100459
Serial #
Z355AA9180; 137) P3700E100463
Serial #
Z346AA9097; 138) P3700E100468
Serial #
A010AA9245; 139) P3700E100468
Serial #
A013AA9246; 140) P3700E100468
Serial #
A013AA9247; 141) P3700E100468
Serial #
A016AA9295; 142) P3700E100468
Serial #
A016AA9296; 143) P3700E100468
Serial #
A016AA9298; 144) P3700E100468
Serial #
A027AA9305; 145) P3700E100468
Serial #
A035AA9382; 146) P3700E100472
Serial #
A031AA9357; 147) P3700E100472
Serial #
A031AA9358; 148) P3700E100476
Serial #
A031AA9355; 149) P3700E100476
Serial #
A031AA9356; 150) P3700E100476
Serial #
A035AA9378; 151) P3700E100476
Serial #
A035AA9379; 152) P3700E100476
Serial #
A035AA9380; 153) P3700E100476
Serial #
A035AA9383; 154) P3700E100476
Serial #
A035AA9387; 155) P3700E100476
Serial #
A036AA9402; 156) P3700E100476
Serial #
A037AA9406; 157) P3700E100476
Serial #
A037AA9408; 158) P3700E100476
Serial #
A037AA9414; 159) P3700E100476
Serial #
A037AA9415; 160) P3700E100477
Serial #
A042AA9433; 161) P3700E100477
Serial #
A042AA9435; 162) P3700E100477
Serial #
A042AA9436; 163) P3700E100477
Serial #
A042AA9437; 164) P3700E100477
Serial #
A042AA9438

What the firm 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.

DistributionShow details

Worldwide distribution - US Nationwide and the countries of BAHRAIN, Canada, Chile, FRANCE, KUWAIT, NETHERLANDS, NORWAY, UNITED ARAB EMIRATES.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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