CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal procedures.
Zavation
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / spinal procedures.
Zavation
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
Beckman Coulter
Class I - Dangerous
specimens collected in transport media may result is false negative results when stored in certain conditions.
Class I - Dangerous
The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required.
Class I - Dangerous
Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
BIOPSYBELL S.R.L.
Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK
BIOPSYBELL S.R.L.
Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
Class I - Dangerous
Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
BIOPSYBELL S.R.L.
Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US
BIOPSYBELL S.R.L.
Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK
BIOPSYBELL S.R.L.
Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15
BIOPSYBELL S.R.L.
Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
Class I - Dangerous
Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB
BIOPSYBELL S.R.L.
Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Roche Diagnostics Operations
Class I - Dangerous
Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.
10 GAUGE DRILL, CODE INTVM-DRL
BIOPSYBELL S.R.L.
Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
BIOPSYBELL S.R.L.
Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.