Complete FDA and NHTSA recall records dated in November 2018.
These records include useful source details for the selected month.
Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer…
Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
The set screw is not able to advance or reverse from the original position in the nail.
The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment.
The set screw is not able to advance or reverse from the original position in the nail.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separate from the Tube Head Mount and potentially fall off the system.
Some eluates become colored because of remaining hemoglobin in the eluate.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Expired intraocular lenses were distributed.
The set screw is not able to advance or reverse from the original position in the nail.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for…
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
A detector can detach and fall.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
