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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96779

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 06, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Baxter Healthcare Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1816-2025
Recall number
Z-1816-2025
Initiated
May 06, 2025
Classification
Class II
Status
Ongoing
Quantity
164 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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