High Risk Recalls

4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 The Soft Tissue Biopsy devices are indicated for use in the...

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2) CIRCUMCISION TRAY W/1.1CM CIRCLAMP, Model Number: CIT3225A; 3) CIRCUMCISION TRAY, Model Number: CIT6325

El David Gelee, Bonbons with fruits Soft & Juicy, 400g. Packaged in decorated paperboard box and covered entirely in transparent, flexible plastic wrap. (20 bonbon pieces per 400g box). UPC...

Undeclared colors (FD&C Yellow 5 and FD&C Red 40).

A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit

A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit

Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device

CRE Pro Wireguided 12-15mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS9715; 4) 20GX3"...

Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C

CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 P4153108D PowerMidline Catheter 3 Fr...

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 S4153108BP Provena Midline...

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188800 CK000884A PowerPICC...

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE; 3) TVS4000L, Model Number: TVS4000 ENDOVENOUS PACK

Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317; 3) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1579A; 4) CSE...

CRE Pro Wireguided 10-12mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

CRE Pro Wireguided 15-18mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

CRE Pro Wireguided 6-8mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universal Central/Art Line Insertion Kit, Model Number: ART155A; 3) ARTERIAL LINE INSERTION TRAY, Model...

CRE Wireguided 8-10mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.