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-0977-2021 | Class II | KD-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - Product Usage: Used with endoscopes... | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | KNS | |
| Z-0976-2021 | Class II | KD-612U ELECTROSURGICAL SNARE, model no. KD-612U - Product Usage: Used with endoscopes... | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | KNS | |
| Z-0975-2021 | Class II | KD-612L ELECTROSURGICAL KNIFE, model no. KD-612L - Product Usage: Used with endoscopes... | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | KNS | |
| Z-0974-2021 | Class II | KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - Product Usage: Used with endoscopes... | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | KNS | |
| Z-0973-2021 | Class II | K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to... | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | EOQ | |
| Z-0972-2021 | Class II | K-203 GUIDE SHEATH Kit 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to... | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | EOQ | |
| Z-0971-2021 | Class II | K-202 GUIDE SHEATH Kit 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to... | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | EOQ | |
| Z-0970-2021 | Class II | K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to... | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | EOQ | |
| Z-0969-2021 | Class II | PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to... | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | FGE | |
| Z-0968-2021 | Class II | B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with... | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | FGE | |
| Z-0967-2021 | Class II | B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: Used with... | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | FGE | |
| Z-0966-2021 | Class II | B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Used with... | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | FGE | |
| Z-0965-2021 | Class II | B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Product Usage: Used with endoscopes... | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | FGE | |
| Z-0964-2021 | Class II | B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with... | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | FGE | |
| Z-0963-2021 | Class II | B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used with... | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | FGE | |
| Z-0962-2021 | Class II | B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - Product Usage: Used with... | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | FGE | |
| Z-0961-2021 | Class II | B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject... | AOMORI OLYMPUS CO., Ltd. Kuroishi Site | FGE | |
| Z-1123-2021 | Class II | Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set... | Baxter Healthcare Corporation | FJK | |
| Z-1122-2021 | Class II | Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product... | Baxter Healthcare Corporation | FJK | |
| Z-1121-2021 | Class II | Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536... | Baxter Healthcare Corporation | FJK | |
| Z-1120-2021 | Class II | Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289... | Baxter Healthcare Corporation | FJK | |
| Z-1119-2021 | Class II | Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage... | Baxter Healthcare Corporation | FJK | |
| Z-1118-2021 | Class II | Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for... | Baxter Healthcare Corporation | FJK | |
| Z-0875-2021 | Class II | ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access... | Siemens Healthcare Diagnostics Inc. | QKO | |
| Z-0948-2021 | Class II | REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile | Allergan | LPN | |
| Z-1649-2022 | Class II | Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System... | Fusion Orthopedics USA, LLC | KTT | |
| Z-0939-2021 | Class II | FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm... | Baxter Healthcare Corporation | MVR | |
| Z-0945-2021 | Class II | Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet... | MAR-MED Inc. | GAX | |
| Z-1507-2024 | Class II | PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from... | Philips North America LLC | JAK | |
| Z-0947-2021 | Class II | Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W... | Philips North America LLC | IYN | |
| Z-2183-2021 | Class II | 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown | Tenderneeds Fertility LLC | MQF | |
| Z-2182-2021 | Class II | Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046 | Tenderneeds Fertility LLC | MQF | |
| Z-2181-2021 | Class II | Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy &... | Tenderneeds Fertility LLC | MQF | |
| Z-2180-2021 | Class II | TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771 | Tenderneeds Fertility LLC | MQF | |
| Z-2179-2021 | Class II | 2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960 | Tenderneeds Fertility LLC | MQF | |
| Z-2178-2021 | Class II | Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW | Tenderneeds Fertility LLC | MQF | |
| Z-2177-2021 | Class II | Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU... | Tenderneeds Fertility LLC | MQF | |
| Z-2176-2021 | Class II | Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt | Tenderneeds Fertility LLC | MQF | |
| Z-2175-2021 | Class II | Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001 | Tenderneeds Fertility LLC | MQF | |
| Z-1364-2021 | Class II | Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811) | Tenderneeds Fertility LLC | MQF | |
| Z-1363-2021 | Class II | Pro Series Fertility Device (SKU 644042788139) | Tenderneeds Fertility LLC | MQF | |
| Z-1362-2021 | Class II | Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962... | Tenderneeds Fertility LLC | MQF | |
| Z-1361-2021 | Class II | Professional Artificial Intrauterine Insemination Kit (SKU 636391205986) | Tenderneeds Fertility LLC | MQF | |
| Z-1360-2021 | Class II | Premium At Home Pro Series Insemination Kit (SKU 644042787927) | Tenderneeds Fertility LLC | MQF | |
| Z-1359-2021 | Class II | Deluxe At Home Artificial Insemination Kit (SKU 636391205832) | Tenderneeds Fertility LLC | MQF | |
| Z-1358-2021 | Class II | Deluxe At Home Pro Series Insemination Kit (SKU 644042787958) | Tenderneeds Fertility LLC | MQF | |
| Z-1357-2021 | Class II | At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870) | Tenderneeds Fertility LLC | MQF | |
| Z-1356-2021 | Class II | At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903) | Tenderneeds Fertility LLC | MQF | |
| Z-1355-2021 | Class II | At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894... | Tenderneeds Fertility LLC | MQF | |
| Z-1104-2021 | Class II | Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for... | Draeger Medical Systems, Inc. | MHX |