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-0164-2023 | Class II | MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures. | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-0163-2023 | Class II | MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical procedures. | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-0162-2023 | Class II | MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures. | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-0161-2023 | Class II | BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical... | MEDLINE INDUSTRIES, LP - Northfield | OJK | |
| Z-0160-2023 | Class II | BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical... | MEDLINE INDUSTRIES, LP - Northfield | OJK | |
| Z-0159-2023 | Class II | BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical procedures. | MEDLINE INDUSTRIES, LP - Northfield | OEZ | |
| Z-0158-2023 | Class II | BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgical... | MEDLINE INDUSTRIES, LP - Northfield | OJK | |
| Z-0157-2023 | Class II | BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical... | MEDLINE INDUSTRIES, LP - Northfield | OJK | |
| Z-0156-2023 | Class II | BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures. | MEDLINE INDUSTRIES, LP - Northfield | OJK | |
| Z-0155-2023 | Class II | BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures. | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-0145-2023 | Class I | Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare... | Baxter Healthcare Corporation | KPN | |
| Z-0144-2023 | Class I | Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare... | Baxter Healthcare Corporation | KPN | |
| Z-0143-2023 | Class I | Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa... | Baxter Healthcare Corporation | KPN | |
| Z-0142-2023 | Class I | Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella... | Baxter Healthcare Corporation | KPN | |
| Z-0141-2023 | Class I | Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product... | Baxter Healthcare Corporation | FNL | |
| Z-0198-2023 | Class II | Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio... | Canon Medical Systems USA, Inc. | IYN | |
| Z-1021-2023 | Class II | biokitHSV-2 Rapid Test, REF: 300028001 | Biokit, S.A. | LGC | |
| Z-0772-2023 | Class II | Pilling Wecksorb Cylindrical Sponges | Teleflex Medical | EFQ | |
| Z-0222-2023 | Class II | X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or... | X-NAV Technologies, LLC | QRY | |
| Z-0271-2023 | Class II | K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013 | Kamiya Biomedical Company, LLC | CFF | |
| Z-0192-2023 | Class II | Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A | Medtronic, Inc. | IME | |
| Z-0191-2023 | Class II | Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600 | Medtronic, Inc. | IME | |
| Z-0190-2023 | Class II | Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A | Medtronic, Inc. | IME | |
| Z-0189-2023 | Class II | Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A | Medtronic, Inc. | IME | |
| Z-0188-2023 | Class II | Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104 | Medtronic, Inc. | IME | |
| Z-0187-2023 | Class II | Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304 | Medtronic, Inc. | IME | |
| Z-0186-2023 | Class II | Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204 | Medtronic, Inc. | IME | |
| Z-0185-2023 | Class II | Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115 | Medtronic, Inc. | IME | |
| Z-0183-2023 | Class II | Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information... | iRhythm Technologies, Inc. | DSI | |
| Z-0201-2023 | Class II | Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L... | Medtronic, Inc. | GAM | |
| Z-0200-2023 | Class II | Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L... | Medtronic, Inc. | GAM | |
| Z-0101-2023 | Class II | DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001 | Synthes (USA) Products LLC | JDR | |
| Z-0100-2023 | Class II | SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910 | Synthes (USA) Products LLC | JDR | |
| Z-0099-2023 | Class II | SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512 | Synthes (USA) Products LLC | JDR | |
| Z-0098-2023 | Class II | SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with... | Synthes (USA) Products LLC | JDR | |
| Z-0219-2023 | Class II | CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15.2CM) DEEP... | Medtronic, Inc. | KCT | |
| Z-0218-2023 | Class II | CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM)... | Medtronic, Inc. | KCT | |
| Z-0217-2023 | Class II | CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP... | Medtronic, Inc. | KCT | |
| Z-0216-2023 | Class II | CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP... | Medtronic, Inc. | KCT | |
| Z-0215-2023 | Class II | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 7" (17.8CM)... | Medtronic, Inc. | KCT | |
| Z-0214-2023 | Class II | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM)... | Medtronic, Inc. | KCT | |
| Z-0213-2023 | Class II | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM)... | Medtronic, Inc. | KCT | |
| Z-0212-2023 | Class II | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM) DEEP... | Medtronic, Inc. | KCT | |
| Z-0211-2023 | Class II | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP... | Medtronic, Inc. | KCT | |
| Z-0210-2023 | Class II | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP... | Medtronic, Inc. | KCT | |
| Z-0209-2023 | Class II | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP... | Medtronic, Inc. | KCT | |
| Z-0208-2023 | Class II | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (10CM) DEEP... | Medtronic, Inc. | KCT | |
| Z-0207-2023 | Class II | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" (15.2CM)... | Medtronic, Inc. | KCT | |
| Z-0206-2023 | Class II | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM)... | Medtronic, Inc. | KCT | |
| Z-0205-2023 | Class II | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP... | Medtronic, Inc. | KCT |