CLASS II ONGOING Device recall · Reported 4 Jun 2025 · FDA Enforcement Report
Affinity 4 Birthing Bed recalled by Baxter Healthcare
Baxter Healthcare is recalling Affinity 4 Birthing Bed, distributed nationwide in the US. The recall was initiated on 6 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1816-2025
- FDA event ID
- 96779
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 May 2025
- FDA classified
- 23 May 2025
- Reported
- 4 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 6 May 2025 | Recall initiated by company | |
| 23 May 2025 | Classified by FDA | +17 days |
| 4 Jun 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the countries of BAHRAIN, Canada, Chile, FRANCE, KUWAIT, NETHERLANDS, NORWAY, UNITED ARAB EMIRATES.
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
Worldwide distribution - US Nationwide and the countries of BAHRAIN, Canada, Chile, FRANCE, KUWAIT, NETHERLANDS, NORWAY, UNITED ARAB EMIRATES.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Baxter Healthcare
All 577| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | PRO+ 36" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Pro+ Mrs Surface For Versacare, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Volara System Volara, HC, NA recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | PRO+ 40" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |