Z-0354-04

Sure Temp Plus Model 690/692 Oral Temperature Probes

Name: Z-0354-04 Sure Temp Plus Model 690/692 Oral Temperature Probes
Creator: Welch Allyn Inc
Published: 2003-12-30
License: https://open.fda.gov/license/

Welch Allyn Inc / initiated 2003-12-30 / Terminated / root cause: manufacturing process

FDA source

Welch Allyn Inc began a recall of Sure Temp Plus Model 690/692 Oral Temperature Probes on 2003-12-30. The reason FDA records is "Mechanical setting errors that result in calibration errors". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0354-04
Status: Terminated
Initiated: 2003-12-30
Posted: 2004-01-16
Terminated: 2004-07-21
Recalling firm: Welch Allyn Inc
Product: Sure Temp Plus Model 690/692 Oral Temperature Probes
Product code: FLL Continuous Measurement Thermometer
Reason for recall: Mechanical setting errors that result in calibration errors.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Recall letters dated 12/29/2003 were sent to all customers requesting quarantine and subrecall if needed. Consignees are to request return authorization for replacement.
Quantity in commerce: 4453
Distribution: Nationwide
Product codes and lots: Welch Allyn¿ Part #s: 0690-XXX Serial Numbers/Lot Numbers 02692-000 Oral Probe 4 ft. 412003-442003, 472003, 522003-582003. 02692-100 Oral Probe 9 ft. 412003-442003, 472003, 522003-582003 02893-000 Oral Probe Well Kit 4 ft. 412003-442003, 472003, 522003-582003 02893-100 Oral Probe Well Kit 9 ft. 412003-442003, 472003, 522003-582003 Probes are contained in Welch Allyn¿ Thermometer Boxes with Part #s: 0690-XXX Serial Numbers/Lot Numbers 01690-000 03397655 - 03505486 01690-200 03397655 - 03505486 E-01690-200 03397655 - 03505486 01690-300 03397655 - 03505486 01690-400 03397655 - 03505486 01690-410 03397655 - 03505486 01690-500 03397655 - 03505486 E-01692-200 03397655 - 03505486 01692-200 03397655 - 03505486 01692-300 03397655 - 03505486 01692-400 03397655 - 03505486 01692-500 03397655 - 03505486 01692-700 03397655 - 03505486 Probes are contained in Welch Allyn¿ Vital Signs Monitor III boxes with Part#s: Serial Numbers/Lot Numbers 53NTO-E1 JA000244, JA000282, JA000283, JA000284, JA000285, JA000286, JA000287, JA000288, JA000289, JA000290, JA000291, JA000292, JA000293, JA000294, JA000295, JA000296, JA000297, JA000298, JA000299, JA000300, JA000301, JA000302, JA000303, JA000304, JA000305, JA000306, JA000307, JA000308, JA000309, JA000310, JA000311, JA000312, JA000313, JA000314, JA000315, JA000316, JA000317, JA000318, JA000319, JA000320, JA000331, JA000332, JA000333, JA000334, JA000335, JA000336, JA000337, JA000340, JA000341, JA000342, JA000343, JA000344, JA000345, JA000347, JA000348, JA000349, JA000352, JA000353, JA000354 53NTP-E1 JA000232, JA000243, JA000246, JA000255, JA000258, JA000259, JA000271, JA000278, JA000281, JA000326, JA000327, JA000328, JA000357

Product code FLL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)