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-0937-2026 | Class II | Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation... | SeaSpine Orthopedics Corporation | OLO | |
| Z-1479-2026 | Class II | Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy... | OLYMPUS Corporation of the Americas | FEO | |
| Z-1478-2026 | Class II | Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE... | OLYMPUS Corporation of the Americas | FEO | |
| Z-1477-2026 | Class II | Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE... | OLYMPUS Corporation of the Americas | FEO | |
| Z-0915-2026 | Class I | GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field... | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-0914-2026 | Class I | GE Healthcare Carestation anesthesia system, product number and REF numbers... | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-0913-2026 | Class I | GE Healthcare Carestation anesthesia system, product number and REF numbers... | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-0930-2026 | Class II | Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09. | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0929-2026 | Class II | Halyard, MAJOR PACK. Catalog Number: JEMJ10-01. | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0928-2026 | Class II | Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01. | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0927-2026 | Class II | Halyard, EP LAB PK. Catalog Number: ESJH009-03. | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0926-2026 | Class II | Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10. | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0885-2026 | Class I | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled... | Fresenius Kabi USA, LLC | FRN | |
| Z-0922-2026 | Class II | FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048 | MEDLINE INDUSTRIES, LP - Northfield | LRW | |
| Z-0921-2026 | Class II | SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000 | MEDLINE INDUSTRIES, LP - Northfield | LRW | |
| Z-0961-2026 | Class II | Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 | Abbott Medical | JJE | |
| Z-0876-2026 | Class II | KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from... | Microbiologics, Inc. | JTR | |
| Z-0958-2026 | Class II | InPen App, Model/CFN Number: MMT-8061 (Android Users) | Medtronic, Inc. | NDC | |
| Z-0963-2026 | Class II | The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed... | Howmedica Osteonics Corp | HAW | |
| Z-0897-2026 | Class II | ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve... | Medtronic, Inc. | FYA | |
| Z-0585-2026 | Class II | 1. Camhb W/lhb, Manual, 11Ml, 10/Box Ycp112-10 2. Brucella Broth, 11Ml, 10/Box Yt3450 | Remel Inc | JTZ | |
| Z-1457-2026 | Class II | Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in... | OLYMPUS Corporation of the Americas | FJL | |
| Z-1456-2026 | Class II | Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in... | OLYMPUS Corporation of the Americas | FJL | |
| Z-1455-2026 | Class II | Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in... | OLYMPUS Corporation of the Americas | FJL | |
| Z-1454-2026 | Class II | Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in... | OLYMPUS Corporation of the Americas | GCP | |
| Z-1453-2026 | Class II | Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in... | OLYMPUS Corporation of the Americas | FJL | |
| Z-1452-2026 | Class II | Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications. | OLYMPUS Corporation of the Americas | FJL | |
| Z-1451-2026 | Class II | Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and... | OLYMPUS Corporation of the Americas | FJL | |
| Z-1450-2026 | Class II | Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and... | OLYMPUS Corporation of the Americas | FJL | |
| Z-1449-2026 | Class II | Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in... | OLYMPUS Corporation of the Americas | HIH | |
| Z-1448-2026 | Class II | Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological... | OLYMPUS Corporation of the Americas | FJL | |
| Z-1447-2026 | Class II | Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in... | OLYMPUS Corporation of the Americas | FJL | |
| Z-1446-2026 | Class II | Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection... | OLYMPUS Corporation of the Americas | FJL | |
| Z-1445-2026 | Class II | Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic... | OLYMPUS Corporation of the Americas | FJL | |
| Z-1444-2026 | Class II | Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection... | OLYMPUS Corporation of the Americas | FJL | |
| Z-1443-2026 | Class II | Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic... | OLYMPUS Corporation of the Americas | FJL | |
| Z-1442-2026 | Class II | Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection... | OLYMPUS Corporation of the Americas | FJL | |
| Z-1441-2026 | Class II | Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic... | OLYMPUS Corporation of the Americas | FJL | |
| Z-1440-2026 | Class II | Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection... | OLYMPUS Corporation of the Americas | FJL | |
| Z-1439-2026 | Class II | Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection... | OLYMPUS Corporation of the Americas | FJL | |
| Z-1438-2026 | Class II | Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and... | OLYMPUS Corporation of the Americas | FJL | |
| Z-1002-2026 | Class I | Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-1001-2026 | Class I | Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17. | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-1000-2026 | Class I | Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15. | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0911-2026 | Class II | DEXLOCK Achilles Repair Implant Kits, MAKT4520 | MEDLINE INDUSTRIES, LP - Northfield | NWN | |
| Z-1221-2026 | Class II | COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an... | Siemens Healthcare Diagnostics Inc. | GIF | |
| Z-0890-2026 | Class II | Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L=... | Waldemar Link GmbH & Co. KG | KRO | |
| Z-0593-2026 | Class I | ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of... | Draeger, Inc. | BZA | |
| Z-0592-2026 | Class I | ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of... | Draeger, Inc. | BZA | |
| Z-0591-2026 | Class I | ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of... | Draeger, Inc. | BZA |