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-1089-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF... | MEDLINE INDUSTRIES, LP - Northfield | OJF | |
| Z-1088-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2)... | MEDLINE INDUSTRIES, LP - Northfield | OHD | |
| Z-1087-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-1086-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF... | MEDLINE INDUSTRIES, LP - Northfield | FDE | |
| Z-1085-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF... | MEDLINE INDUSTRIES, LP - Northfield | OEZ | |
| Z-1298-2026 | Class II | Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10 | Wilson-Cook Medical Inc. | KNT | |
| Z-1369-2026 | Class II | Estrone RIA, REF: DSL8700 | IMMUNOTECH s.r.o. | CGF | |
| Z-1136-2026 | Class II | TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes... | Sysmex America, Inc. | LXG | |
| Z-1117-2026 | Class I | Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog... | Salter Labs | OKI | |
| Z-1116-2026 | Class I | Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog... | Salter Labs | OKI | |
| Z-1115-2026 | Class I | Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow... | Salter Labs | OKI | |
| Z-1114-2026 | Class I | Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow... | Salter Labs | OKI | |
| Z-1096-2026 | Class II | da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073... | Intuitive Surgical, Inc. | NAY | |
| Z-1077-2026 | Class II | Allura Xper FD20/20; Model Number: 722038; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1076-2026 | Class II | Allura Xper FD20/10; Model Number: 722029; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1075-2026 | Class II | Allura Xper FD20; Model Number: 722028; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1074-2026 | Class II | Allura Xper FD10/10; Model Number: 722027; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1073-2026 | Class II | Allura Xper FD10; Model Number: 722026; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1072-2026 | Class II | Allura Xper FD20 OR Table; Model Number: 722023; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1071-2026 | Class II | Allura Xper FD20 Biplane; Model Number: 722013; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1070-2026 | Class II | Allura Xper FD20; Model Number: 722012; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1069-2026 | Class II | Allura Xper FD10/10; Model Number: 722011; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1068-2026 | Class II | Allura Xper FD10; Model Number: 722010; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1067-2026 | Class II | Allura Xper FD20 Biplane; Model Number: 722008; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1066-2026 | Class II | Allura Xper FD20; Model Number: 722006; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1065-2026 | Class II | Allura Xper FD10/10; Model Number: 722005; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1064-2026 | Class II | Allura Xper FD10; Model Number: 722003; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1063-2026 | Class II | Allura Xper FD10F; Model Number: 722002; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1130-2026 | Class II | Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR... | Leaseir Technologies SLU | GEX | |
| Z-1314-2026 | Class II | Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. | Hologic, Inc. | KNW | |
| Z-1084-2026 | Class II | Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for... | Diagnostica Stago, Inc. | LCO | |
| Z-1094-2026 | Class II | Plum Duo Infusion System, List Number 40002-04-01 | Abbott Medical | FRN | |
| Z-1120-2026 | Class II | ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001... | Abbott Medical | FRN | |
| Z-1119-2026 | Class II | ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003... | Abbott Medical | FRN | |
| Z-1118-2026 | Class II | ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines) | Abbott Medical | FRN | |
| Z-1062-2026 | Class II | Product Name: Allura Xper FD10C; Model number: 722001; | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1164-2026 | Class II | Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta... | Elekta Limited | IYE | |
| Z-1200-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit... | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-1199-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU... | MEDLINE INDUSTRIES, LP - Northfield | OHM | |
| Z-1198-2026 | Class II | Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit SKU... | MEDLINE INDUSTRIES, LP - Northfield | OHG | |
| Z-1197-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF... | MEDLINE INDUSTRIES, LP - Northfield | OHD | |
| Z-1196-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit... | MEDLINE INDUSTRIES, LP - Northfield | OJG | |
| Z-1195-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG... | MEDLINE INDUSTRIES, LP - Northfield | OXQ | |
| Z-1194-2026 | Class II | Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit... | MEDLINE INDUSTRIES, LP - Northfield | OVN | |
| Z-1193-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-1192-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF... | MEDLINE INDUSTRIES, LP - Northfield | FTN | |
| Z-1191-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit... | MEDLINE INDUSTRIES, LP - Northfield | FDE | |
| Z-1190-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU... | MEDLINE INDUSTRIES, LP - Northfield | OGR | |
| Z-1189-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF... | MEDLINE INDUSTRIES, LP - Northfield | OFG | |
| Z-1188-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit... | MEDLINE INDUSTRIES, LP - Northfield | OEZ |