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-0174-2007 | Asahi AM-BIO D Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer... | Asahi Kasei Medical MT Corp. Oita Works | MSE | ||
| Z-0173-2007 | Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model single or multiple use dialyzer... | Asahi Kasei Medical MT Corp. Oita Works | MSE | ||
| Z-0172-2007 | Asahi Rexeed Series Multiple-Use Hollow Fiber Dialyzers; a wet model multiple use... | Asahi Kasei Medical MT Corp. Oita Works | KDI | ||
| Z-0171-2007 | Asahi APS Series Multiple-Use Hollow Fiber Dialyzers; a wet model multiple use dialyzer... | Asahi Kasei Medical MT Corp. Oita Works | KDI | ||
| Z-2236-2012 | Class II | OEC InstaTrak 3500, picture archiving and communications system intended as an aid to... | GE Healthcare | LLZ | |
| Z-0651-2007 | NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral... | Zimmer GmbH | JWH | ||
| Z-0650-2007 | NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral... | Zimmer GmbH | JWH | ||
| Z-0649-2007 | NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral... | Zimmer GmbH | JWH | ||
| Z-0648-2007 | NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral... | Zimmer GmbH | JWH | ||
| Z-0647-2007 | NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral... | Zimmer GmbH | JWH | ||
| Z-0263-2007 | OneTouchBasic/Profile and OneTouch Ultra- Blood Glucose test strips. For use with ONE... | Milwaukee Notions, Inc | CGA | ||
| Z-0188-2007 | ambIT Ambulatory Infusion Pump Cassette; Filterless, Male, Sterile, Vol. 2.3ml, REF... | Sorenson Medical, Inc. | FRN | ||
| Z-0187-2007 | ambIT Ambulatory Infusion Pump Cassette; Filter, Male, Sterile, Vol. 2.3ml, REF 220266... | Sorenson Medical, Inc. | FRN | ||
| Z-0186-2007 | ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile, Vol. 2.3ml, REF 220140... | Sorenson Medical, Inc. | FRN | ||
| Z-0185-2007 | ambIT Ambulatory Infusion Pump Cassette; Filterless, Spike, Sterile, Vol. 2.3ml, REF... | Sorenson Medical, Inc. | FRN | ||
| Z-0144-2007 | HI Fix Skull Pins, DePuy Spine Bremer Halo System Product Code: AC020 | DePuy Spine, Inc. | HWC | ||
| Z-0143-2007 | Extra Long Skull Pins, DePuy Spine Bremer Halo System Product Number: AC018 | DePuy Spine, Inc. | HWC | ||
| Z-0142-2007 | Skull pins w/Torque, DePuy Spine Bremer Halo System Product Code: AC014 | DePuy Spine, Inc. | HWC | ||
| Z-0141-2007 | Standard Skull Rings, DePuy Spine Bremer Halo System Product Code: AC007 | DePuy Spine, Inc. | HWC | ||
| Z-0140-2007 | Large Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT002 | DePuy Spine, Inc. | HWC | ||
| Z-0139-2007 | Small Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT001 | DePuy Spine, Inc. | HWC | ||
| Z-0138-2007 | Adjustable Ring Traction Set, Size C, DePuy Spine Bremer Halo System Product Code: HT002 | DePuy Spine, Inc. | HWC | ||
| Z-0137-2007 | Adjustable Ring Traction Set, Size B, DePuy Spine Bremer Halo System Product Code: HT001 | DePuy Spine, Inc. | HWC | ||
| Z-0136-2007 | Large Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Number: HT026HI | DePuy Spine, Inc. | HWC | ||
| Z-0135-2007 | Small Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Code: HT025HI | DePuy Spine, Inc. | HWC | ||
| Z-0134-2007 | Large Halo Crown, DePuy Spine Bremer Halo System Product Number: HT026 | DePuy Spine, Inc. | HWC | ||
| Z-0133-2007 | Small Halo Crown, DePuy Spine Bremer Halo System Product Number: HT025 | DePuy Spine, Inc. | HWC | ||
| Z-0132-2007 | 12 Degree Slider Set, DePuy Spine Bremer Halo System Product Code: 2923-01-020 | DePuy Spine, Inc. | HWC | ||
| Z-0131-2007 | 0 Degree Slider Set, DePuy Spine Bremer Halo System Product Code: 2923-01-010 | DePuy Spine, Inc. | HWC | ||
| Z-0130-2007 | DePuy Spine Bremer 3-D Halo Crown System Product Code: 2923-01-100 | DePuy Spine, Inc. | HWC | ||
| Z-0485-2007 | Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with... | Fisher & Paykel Healthcare, Inc. | FMT | ||
| Z-0477-2007 | One Touch Ultra Blood Glucose Test Strips-Lot # 2691191, LifeScan | Matrix Distributors, Inc. | NBW | ||
| Z-0245-2007 | VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60... | Ortho-Clinical Diagnostics, Inc. | CHI | ||
| Z-0794-2007 | Boston Scientific Medi-Tech Stainless Steel Greenfield Vena Cava Filter, order #50-400... | Boston Scientific Corporation | DTK | ||
| Z-0220-2007 | Konica Minolta PrintLink III Model - ID/IV, code no. 0770, 0771 Medical Imaging... | Konica Minolta, Inc. | LMD | ||
| Z-0298-2007 | St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model... | Abbott Medical | DXY | ||
| Z-0297-2007 | St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical... | Abbott Medical | KRG | ||
| Z-0296-2007 | St. Jude Medical APS III Programmer, used in combination with St. Jude Medical... | Abbott Medical | KRG | ||
| Z-0150-2007 | Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C ; each... | Home Access Health Corp. | MZO | ||
| Z-0014-2011 | Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No... | Howmedica Osteonics Corp | JWH | ||
| Z-0535-2007 | FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St... | Abbott Medical | DYB | ||
| Z-0190-2007 | Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Part number: 07.00684.00... | Zimmer Spine, Inc. | KWP | ||
| Z-0160-2007 | Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road... | Wilson-Cook Medical Inc. | KOG | ||
| Z-0837-2007 | LIFEPAK EXPRESS defibrillator | Physio Control, Inc. | MKJ | ||
| Z-0836-2007 | LIFEPAK CR Plus defibrillator | Physio Control, Inc. | MKJ | ||
| Z-0229-2007 | Laborie Transducer Cartridge with Luer Lock Reference: DIS130 | Abbott Medical | FEN | ||
| Z-0153-2007 | Precision Medical- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series... | Precision Medical, Inc. | BYJ | ||
| Z-0445-2007 | SPS Blue Line Tube Clamp Adapters, Product No. BL120M | Southern Prosthetic Supply Co. | ISH | ||
| Z-0069-2007 | Sienet Cosmos V15C, picture archiving and communications system. Model number 10018969 | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0217-2007 | Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat... | Biogenex Laboratories, Inc. | NJT |