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-1100-2019 | Class II | Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr... | Edwards Lifesciences LLC | DXC | |
| Z-2436-2020 | Class II | Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on... | Westmed Inc | BYE | |
| Z-2435-2020 | Class II | Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on... | Westmed Inc | BYE | |
| Z-2434-2020 | Class II | Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant... | Westmed Inc | BYE | |
| Z-0603-2020 | Class II | Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal... | Miami Device Solutions, LLC | HRS | |
| Z-1040-2019 | Class II | Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be... | FUJIFILM Healthcare Americas Corporation | IZL | |
| Z-0981-2019 | Class II | BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX... | Becton Dickinson & Co | PIC | |
| Z-1206-2019 | Class II | Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated... | Arthrex GmbH | GFF | |
| Z-0864-2019 | Class II | TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography... | Shimadzu Medical Systems | OWB | |
| Z-0959-2019 | Class II | BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be... | Shimadzu Medical Systems | IZI | |
| Z-1975-2019 | Class III | RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device | Teleflex Medical | KNX | |
| Z-1974-2019 | Class III | RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device | Teleflex Medical | KNX | |
| Z-1039-2019 | Class II | SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This... | Shimadzu Medical Systems | IZL | |
| Z-0791-2019 | Class II | 3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602... | 3M Company | LWK | |
| Z-1019-2019 | Class II | aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical... | AAP Implantate AG | KDG | |
| Z-1256-2019 | Class III | Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test... | Lin-Zhi International Inc | DIC | |
| Z-0962-2019 | Class II | Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347... | bioMerieux, Inc. | LON | |
| Z-1906-2019 | Class II | EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software... | Bio-Rad Laboratories Inc. | JJE | |
| Z-1119-2019 | Class II | Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQY | |
| Z-1118-2019 | Class II | Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQY | |
| Z-1239-2019 | Class II | AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin... | Wallac Oy | JHJ | |
| Z-1238-2019 | Class II | AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin... | Wallac Oy | JHJ | |
| Z-1237-2019 | Class II | DELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin... | Wallac Oy | JHJ | |
| Z-0828-2019 | Class II | 21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the... | Ottobock Orthopedic Industrie | ISY | |
| Z-0827-2019 | Class II | 21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended... | Ottobock Orthopedic Industrie | ISY | |
| Z-0826-2019 | Class II | 21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for... | Ottobock Orthopedic Industrie | ISY | |
| Z-1942-2020 | Class III | Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF... | Karl Storz Endoscopy-America, Inc. | NKC | |
| Z-1126-2020 | Class II | SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 | Implant Direct Sybron Manufacturing LLC | NHA | |
| Z-1038-2019 | Class II | FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is... | ConvaTec Limited | JOL | |
| Z-1037-2019 | Class II | Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as... | ConvaTec Limited | KOD | |
| Z-1036-2019 | Class II | Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray... | ConvaTec Limited | FPD | |
| Z-1035-2019 | Class II | Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are... | ConvaTec Limited | HTD | |
| Z-0861-2019 | Class II | PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to... | Philips North America LLC | DPS | |
| Z-0860-2019 | Class II | PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including... | Philips North America LLC | DPS | |
| Z-0859-2019 | Class II | PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to... | Philips North America LLC | DPS | |
| Z-0858-2019 | Class II | PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to... | Philips North America LLC | DPS | |
| Z-0857-2019 | Class II | PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and... | Philips North America LLC | DPS | |
| Z-0856-2019 | Class II | PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to... | Philips North America LLC | DPS | |
| Z-0855-2019 | Class II | PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to... | Philips North America LLC | DPS | |
| Z-0854-2019 | Class II | PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used... | Philips North America LLC | DPS | |
| Z-0853-2019 | Class II | PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used... | Philips North America LLC | DPS | |
| Z-0773-2019 | Class II | NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi... | Neusoft Medical Systems Imp & EX | JAK | |
| Z-0990-2019 | Class II | Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number... | Getinge US Sales LLC | FSY | |
| Z-0989-2019 | Class II | Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part... | Getinge US Sales LLC | FSY | |
| Z-0988-2019 | Class II | Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Part Number... | Getinge US Sales LLC | FSY | |
| Z-0987-2019 | Class II | Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number... | Getinge US Sales LLC | FSY | |
| Z-2355-2020 | Class II | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open... | Acuity Surgical Devices, LLC | OVD | |
| Z-2354-2020 | Class II | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary... | Acuity Surgical Devices, LLC | OVD | |
| Z-0991-2019 | Class II | AVE 2 Birthing Bed | LINET spol. s r.o. | HDD | |
| Z-0730-2019 | Class II | Sl Plus Mia Double Offset Adapter Right 60/25Mm, S&n 75004613 | Smith & Nephew, Inc. | LXH |