SEDECAL SA Model Number SM-40HF-B-D-C recall — FDA Z-0259-2026
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly…
Complete FDA and NHTSA recall records dated in 2025, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly…
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly…
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly…
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are…
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly…
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are…
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly…
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly…
The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly…
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support.…
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support.…
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly…
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly…
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support.…
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly…
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are…
Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual…
Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could…
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a…
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly…
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.