Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-1092-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30... | MEDLINE INDUSTRIES, LP - Northfield | OHM | |
| Z-1091-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP... | MEDLINE INDUSTRIES, LP - Northfield | OHD | |
| Z-1090-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY | MEDLINE INDUSTRIES, LP - Northfield | MLT | |
| Z-1089-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER... | MEDLINE INDUSTRIES, LP - Northfield | MLS | |
| Z-1088-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT... | MEDLINE INDUSTRIES, LP - Northfield | OJG | |
| Z-1087-2023 | Class II | Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK | MEDLINE INDUSTRIES, LP - Northfield | NSB | |
| Z-1086-2023 | Class II | Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK | MEDLINE INDUSTRIES, LP - Northfield | KKX | |
| Z-1085-2023 | Class II | Sterile Procedural Trays, labeled as the following: LS MS PACK | MEDLINE INDUSTRIES, LP - Northfield | FMH | |
| Z-1084-2023 | Class II | Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF | MEDLINE INDUSTRIES, LP - Northfield | ORO | |
| Z-1083-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c... | MEDLINE INDUSTRIES, LP - Northfield | OJJ | |
| Z-1082-2023 | Class II | Sterile Procedural Trays, labeled as the following: IM NAIL | MEDLINE INDUSTRIES, LP - Northfield | MDM | |
| Z-1081-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK | MEDLINE INDUSTRIES, LP - Northfield | MCY | |
| Z-1080-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE... | MEDLINE INDUSTRIES, LP - Northfield | LRS | |
| Z-1079-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-1078-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET... | MEDLINE INDUSTRIES, LP - Northfield | KDD | |
| Z-1077-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST... | MEDLINE INDUSTRIES, LP - Northfield | FTN | |
| Z-1076-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO | MEDLINE INDUSTRIES, LP - Northfield | PPB | |
| Z-1075-2023 | Class II | Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY | MEDLINE INDUSTRIES, LP - Northfield | NWU | |
| Z-1074-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY... | MEDLINE INDUSTRIES, LP - Northfield | FDE | |
| Z-1073-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST... | MEDLINE INDUSTRIES, LP - Northfield | FCH | |
| Z-1072-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE... | MEDLINE INDUSTRIES, LP - Northfield | OGR | |
| Z-1071-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY... | MEDLINE INDUSTRIES, LP - Northfield | MMO | |
| Z-1070-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b... | MEDLINE INDUSTRIES, LP - Northfield | OFX | |
| Z-1069-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST... | MEDLINE INDUSTRIES, LP - Northfield | OFG | |
| Z-1068-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b... | MEDLINE INDUSTRIES, LP - Northfield | OFF | |
| Z-1067-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN... | MEDLINE INDUSTRIES, LP - Northfield | OEZ | |
| Z-1066-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b... | MEDLINE INDUSTRIES, LP - Northfield | OES | |
| Z-1065-2023 | Class II | FEMORAL ARTERY PACK-LF. Sterile Procedural Tray | MEDLINE INDUSTRIES, LP - Northfield | OEQ | |
| Z-1064-2023 | Class II | UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray | MEDLINE INDUSTRIES, LP - Northfield | OGS | |
| Z-1063-2023 | Class II | Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL... | MEDLINE INDUSTRIES, LP - Northfield | OFT | |
| Z-1062-2023 | Class II | LOCAL PACK. Sterile Procedural Tray. | MEDLINE INDUSTRIES, LP - Northfield | OFQ | |
| Z-1061-2023 | Class II | TRACH PACK. Sterile Procedural Tray. | MEDLINE INDUSTRIES, LP - Northfield | NXA | |
| Z-1035-2023 | Class II | Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-1034-2023 | Class II | Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-1033-2023 | Class II | Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-1032-2023 | Class II | Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-1031-2023 | Class II | Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case | MEDLINE INDUSTRIES, LP - Northfield | FDE | |
| Z-1030-2023 | Class II | Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case | MEDLINE INDUSTRIES, LP - Northfield | FDE | |
| Z-1029-2023 | Class II | Non-sterile procedural trays labeled as CRANI, 2 per case | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-1060-2023 | Class II | ANCILLARY PACK-LF. Sterile Procedural Tray. | MEDLINE INDUSTRIES, LP - Northfield | CAI | |
| Z-0878-2023 | Class II | VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative... | Ortho-Clinical Diagnostics, Inc. | CEW | |
| Z-0775-2023 | Class II | Programmable Diagnostic Computer | Siemens Medical Solutions USA, Inc. | DQK | |
| Z-0480-2023 | Class II | PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code... | Ethicon, Inc | NEW | |
| Z-0733-2023 | Class II | B125M Patient Monitor, REF 6160000-005-XXXXXXX | GE Healthcare | MHX | |
| Z-0732-2023 | Class II | B125M Patient Monitor, REF 6160000-004-XXXXXX | GE Healthcare | MHX | |
| Z-0731-2023 | Class II | B105M Patient Monitor, REF 6160000-003 | GE Healthcare | MHX | |
| Z-0730-2023 | Class II | B125P Patient Monitor (with E-module slot option), REF 6160000-002 | GE Healthcare | MHX | |
| Z-0729-2023 | Class II | B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX, | GE Healthcare | MHX | |
| Z-0723-2023 | Class II | ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive | ConvaTec Limited | FRO | |
| Z-1133-2023 | Class II | iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE | ConforMIS, Inc. | OIY |