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-1293-2020 | Class II | Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product... | Medtronic, Inc. | GAM | |
| Z-1292-2020 | Class II | Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product... | Medtronic, Inc. | GAM | |
| Z-1291-2020 | Class II | Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product... | Medtronic, Inc. | GAM | |
| Z-1290-2020 | Class II | Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage... | Medtronic, Inc. | GAM | |
| Z-1289-2020 | Class II | Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage... | Medtronic, Inc. | GAM | |
| Z-1288-2020 | Class II | Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product... | Medtronic, Inc. | GAM | |
| Z-1287-2020 | Class II | Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage... | Medtronic, Inc. | GAM | |
| Z-1286-2020 | Class II | Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage... | Medtronic, Inc. | GAM | |
| Z-1285-2020 | Class II | Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage... | Medtronic, Inc. | GAM | |
| Z-1284-2020 | Class II | Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage... | Medtronic, Inc. | GAM | |
| Z-1283-2020 | Class II | Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage... | Medtronic, Inc. | GAM | |
| Z-1282-2020 | Class II | Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage... | Medtronic, Inc. | GAM | |
| Z-1281-2020 | Class II | Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage... | Medtronic, Inc. | GAM | |
| Z-1280-2020 | Class II | Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage... | Medtronic, Inc. | GAM | |
| Z-1279-2020 | Class II | Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product... | Medtronic, Inc. | GAM | |
| Z-1278-2020 | Class II | Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage... | Medtronic, Inc. | GAM | |
| Z-1277-2020 | Class II | Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage... | Medtronic, Inc. | GAM | |
| Z-1276-2020 | Class II | Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage... | Medtronic, Inc. | GAM | |
| Z-1275-2020 | Class II | Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage... | Medtronic, Inc. | GAM | |
| Z-1274-2020 | Class II | Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product... | Medtronic, Inc. | GAM | |
| Z-1233-2020 | Class II | Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444 | Siemens Healthcare Diagnostics Inc. | JFY | |
| Z-1232-2020 | Class II | Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520 | Siemens Healthcare Diagnostics Inc. | JFY | |
| Z-1231-2020 | Class II | Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533 | Siemens Healthcare Diagnostics Inc. | JFY | |
| Z-1230-2020 | Class II | ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869 | Siemens Healthcare Diagnostics Inc. | JFY | |
| Z-2052-2020 | Class II | Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is... | W. L. Gore & Associates, Inc. | MIH | |
| Z-2107-2020 | Class II | Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7... | Quest Medical, Inc | DTR | |
| Z-2045-2020 | Class II | AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage... | Boston Scientific Corporation | JCW | |
| Z-0861-2020 | Class II | VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:8719214221669 | Vitreq BV | GAA | |
| Z-0860-2020 | Class II | VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719214221645 | Vitreq BV | GAA | |
| Z-0859-2020 | Class II | VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719214221621 | Vitreq BV | GAA | |
| Z-0858-2020 | Class II | VitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607 | Vitreq BV | GAA | |
| Z-0857-2020 | Class II | VitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584 | Vitreq BV | GAA | |
| Z-0856-2020 | Class II | VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522 | Vitreq BV | HMX | |
| Z-0855-2020 | Class II | VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508 | Vitreq BV | HMX | |
| Z-0854-2020 | Class II | VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485 | Vitreq BV | HMX | |
| Z-0853-2020 | Class II | VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461 | Vitreq BV | HMX | |
| Z-0852-2020 | Class II | VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447 | Vitreq BV | HMX | |
| Z-0851-2020 | Class II | VitreQ 23G VFI Cannula-REF: CN23.D03 GTIN: 8719214221423 | Vitreq BV | HMX | |
| Z-0850-2020 | Class II | VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386 | Vitreq BV | GAA | |
| Z-0849-2020 | Class II | VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362 | Vitreq BV | GAA | |
| Z-0848-2020 | Class II | (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF Brush... | Vitreq BV | GAA | |
| Z-0847-2020 | Class II | (1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush... | Vitreq BV | GAA | |
| Z-0846-2020 | Class II | (1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush... | Vitreq BV | GAA | |
| Z-0919-2020 | Class II | Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger... | Arthrex GmbH | LXH | |
| Z-1127-2020 | Class II | Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product... | Medartis AG | HRS | |
| Z-1226-2020 | Class II | VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1... | Ortho-Clinical Diagnostics, Inc. | JIX | |
| Z-0883-2020 | Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product... | Synthes GmbH | HRS | |
| Z-0882-2020 | Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product... | Synthes GmbH | HRS | |
| Z-0881-2020 | Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product... | Synthes GmbH | HRS | |
| Z-0880-2020 | Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product... | Synthes GmbH | HRS |
