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-0385-04 | Products are various dental surgical drills packed in a sealed tray and labeled as... | ZimVie US Corp LLC | DZI | ||
| Z-0384-04 | Products are various dental surgical drills packed in a sealed tray and labeled as... | ZimVie US Corp LLC | DZI | ||
| Z-0383-04 | Products are various dental surgical drills packed in a sealed tray and labeled as... | ZimVie US Corp LLC | DZI | ||
| Z-0297-04 | Abbott Commander Flexible Pipetting Center (FPC) Operations Manual, list 6A97-27; Abbott... | Abbott Medical | JQW-- | ||
| Z-0234-04 | Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x... | Medtronic, Inc. | MPB | ||
| Z-0233-04 | Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For... | Medtronic, Inc. | MPB | ||
| Z-0317-04 | MedGraphics Cardiorespiratory Diagnostic Systems Pulmonary Function Gas, For Diagnostic... | Puritan Medical Products Company, LLC | BXH | ||
| Z-0267-04 | Stryker brand Model 1550 Synergy Extended Stay Stretcher | Stryker Medical | INK | ||
| Z-0298-04 | Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per... | Ortho-Clinical Diagnostics, Inc. | JHX | ||
| Z-0276-04 | Hypoguard Advance Blood Glucose Monitoring System, includes Hypoguard Advance Blood... | Arkray Factory USA, Inc. | CGA | ||
| Z-0275-04 | Hypoguard Advance Blood Glucose Strips, 10, 50, and 100 strip bottles. | Arkray Factory USA, Inc. | CGA | ||
| Z-0291-04 | Candela Smoothbeam Laser System Model Numbers: 9914-00-0820... | Candela Corporation | GEX | ||
| Z-0207-04 | SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266. | AGFA Healthcare Corp. | LMC | ||
| Z-0322-04 | CA 125 Controls, list 9C22-10; Abbott Laboratories, Abbott Park, IL 60064 | Abbott Medical | LTK-- | ||
| Z-0321-04 | AxSYM CA 125 Master Calibrators, list 3B41-30; Abbott Laboratories, Abbott Park, IL 60064 | Abbott Medical | LTK-- | ||
| Z-0320-04 | CA 125 Calibrators, list 9C22-01; Abbott Laboratories, Abbott Park, IL 60064 | Abbott Medical | LTK-- | ||
| Z-0319-04 | IMx CA 125 Mode 1 Calibrator, list 7A89-40; Abbott Laboratories, Abbott Park, IL 60064 | Abbott Medical | LTK-- | ||
| Z-0318-04 | AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125 Reagent Pack, list 7A89-22; 100... | Abbott Medical | LTK-- | ||
| Z-0226-04 | FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL45. | Ethicon Endo-Surgery Inc | LFL | ||
| Z-0225-04 | FlexTray Procedure Delivery System Endopath Gastric Tray, Product #KGB11. | Ethicon Endo-Surgery Inc | LFL | ||
| Z-0224-04 | FlexTray Procedure Delivery System Endopath Gynecololgy Tray, Product #FN065. | Ethicon Endo-Surgery Inc | HET | ||
| Z-0223-04 | FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL56. | Ethicon Endo-Surgery Inc | LFL | ||
| Z-0222-04 | General Laparoscopic Tray, Product #TGL53. | Ethicon Endo-Surgery Inc | LFL | ||
| Z-0221-04 | General Laparoscopic Tray, Product #TGL33. | Ethicon Endo-Surgery Inc | LFL | ||
| Z-0220-04 | FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL22. | Ethicon Endo-Surgery Inc | LFL | ||
| Z-0219-04 | FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #KNB21. | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0218-04 | FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #KBW16. | Ethicon Endo-Surgery Inc | LFL | ||
| Z-0217-04 | FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD064. | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0216-04 | FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #FBW24. | Ethicon Endo-Surgery Inc | LFL | ||
| Z-0215-04 | FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD063. | Ethicon Endo-Surgery Inc | HET | ||
| Z-0214-04 | FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD065. | Ethicon Endo-Surgery Inc | HET | ||
| Z-0213-04 | Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm... | Ethicon Endo-Surgery Inc | KOG | ||
| Z-0212-04 | Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm... | Ethicon Endo-Surgery Inc | GDW | ||
| Z-0817-04 | Bacchus brand Trellis Reserve, Peripheral Infusion System, 6.0 Fr Catalog Numbers: BAC... | Bacchus Vascular, Inc. | KRA | ||
| Z-0816-04 | Bacchus brand Trellis Plus, Peripheral Infusion System, 6.0 Fr Catalog Numbers: BAC TRR... | Bacchus Vascular, Inc. | KRA | ||
| Z-0240-04 | AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30 | Abbott Medical | CDQ | ||
| Z-0550-04 | Clinical Chemistry Urea Nitrogen | Abbott Medical | |||
| Z-0281-04 | Pediatric Air Aspirator Needle manufactured by Novosci Corp., The Woodlands, TX | Novosci Corp | GAA | ||
| Z-0293-04 | IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture... | Abbott Medical | CGN-- | ||
| Z-1596-05 | LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and... | Lifescan, Inc. | NBW | ||
| Z-0379-04 | CVS Pharmacy One Step Cleaning & Disinfecting Solution No Rub, For soft contact lenses... | CVS Pharmacy, Inc. | LYL | ||
| Z-0271-04 | Philips Digital Diagnost VT | Philips North America LLC | KPR | ||
| Z-0242-04 | VAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood. | Edwards Lifesciences LLC | KRA | ||
| Z-0270-04 | Digital Diagnost VE | Philips North America LLC | KPR | ||
| Z-0253-04 | SurgAssist System Circular Stapler DLU 33mm | Power Medical Interventions, Inc. | GWD | ||
| Z-0252-04 | SurgAssist System Circular Stapler DLU 29mm | Power Medical Interventions, Inc. | GWD | ||
| Z-0218-06 | CryoValve, Pulmonary Valve & Conduit SG | Artivion, Inc. | MIE | ||
| Z-0217-06 | CryoValve, Pulmonary Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-0216-06 | CryoValve, Pulmonary Valve | Artivion, Inc. | MIE | ||
| Z-0215-06 | CryoValve, Aortic Valve & Conduit SG | Artivion, Inc. | MIE |