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-1414-2022 | Class II | Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02. | Baxter Healthcare Corporation | IOQ | |
| Z-1413-2022 | Class II | Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01. | Baxter Healthcare Corporation | IOQ | |
| Z-1412-2022 | Class II | Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03. | Baxter Healthcare Corporation | IOQ | |
| Z-1465-2022 | Class III | ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000 | Carl Zeiss Microscopy, LLC | MTX | |
| Z-1483-2022 | Class II | Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon... | Medtronic, Inc. | LOX | |
| Z-1502-2022 | Class II | UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool | Neotract Inc | PEW | |
| Z-1478-2022 | Class II | Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy... | Stryker Corp. | HBE | |
| Z-1411-2022 | Class II | Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01... | Baxter Healthcare Corporation | IOQ | |
| Z-1508-2022 | Class II | The Cholestech LDX System combines enzymatic methodology and solidphase technology to... | Alere San Diego, Inc. | CGA | |
| Z-1451-2022 | Class II | LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control | LumiraDx | QKO | |
| Z-1450-2022 | Class II | LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip | LumiraDx | QKO | |
| Z-1818-2022 | Class II | Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool... | DICOM Grid (dba Ambra Health) | LLZ | |
| Z-1745-2022 | Class II | INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas... | Mallinckrodt, Inc. | MRN | |
| Z-1547-2022 | Class II | Ky Jelly Lubricant 2 Fl Oz, Sku 901443 | Family Dollar Stores | NUC | |
| Z-1546-2022 | Class II | Lifestyles Ultra Sensitive Condoms 12Ct, Sku 900265 | Family Dollar Stores | HIS | |
| Z-1545-2022 | Class II | Simply Saline Nasal Mist 3.1 Oz, Sku 999801 | Family Dollar Stores | KCO | |
| Z-1544-2022 | Class II | Polident Denture Cleansers 84 CT, Sku 901634 Polident Denture Clns Tab 28Ct, Sku 906131 | Family Dollar Stores | EFT | |
| Z-1543-2022 | Class II | Gs Saline Solution 12Fl Oz, Sku 902274 | Family Dollar Stores | NGT | |
| Z-1542-2022 | Class II | At Home Marijuana Test Strip, Sku 900752 | Family Dollar Stores | LDJ | |
| Z-1541-2022 | Class II | New Skin Liquid Bandage Clear .3Fl Oz, Sku 999417 | Family Dollar Stores | KMF | |
| Z-1540-2022 | Class II | Opti Free Replenish Multi Purpose 2 Oz | Family Dollar Stores | LPN | |
| Z-1539-2022 | Class II | Poligrip Adh Cream Free 2.4Oz, Sku 900334 Poligrip Denture Adhesive Original 2.4Oz, Sku... | Family Dollar Stores | KOO | |
| Z-1538-2022 | Class II | Fixodent Org Cream 2.4Oz, Sku 906018 Fixodent Org Cream Travel .75Oz, Sku 901239 | Family Dollar Stores | KOO | |
| Z-1537-2022 | Class II | First Response 2 CT, Sku 902343 | Family Dollar Stores | LCX | |
| Z-1536-2022 | Class II | Curad Strng Watrprf Strip 1In 20Ct, Sku | Family Dollar Stores | KGX | |
| Z-1535-2022 | Class II | Trvl Kit Tothbrsh Cap Paste in Pouch 1Ct, Sku 900737 | Family Dollar Stores | EFW | |
| Z-1534-2022 | Class II | Gs Denture Cleanser Grn Tab 40Ct, Sku 906312 Gs Denture Clean Ovrnt Tab 40Ct, Sku 906023 | Family Dollar Stores | EFT | |
| Z-1533-2022 | Class II | Clear Eyes Contct Lens Drps Lbrctng .5Fo, Sku 900531 | Family Dollar Stores | LPN | |
| Z-1532-2022 | Class II | Curad First Aid Kit, Sku 999037 | Family Dollar Stores | LRR | |
| Z-1531-2022 | Class II | B L Biotru Multi Purpose Solution 4 Floz, Sku 999009 | Family Dollar Stores | LPN | |
| Z-1530-2022 | Class II | Skyn Original Non Latex Condom 12Ct, Sku 903409 Ls Skyn Non Latex Lubricated Condom 3Ct... | Family Dollar Stores | MOL | |
| Z-1529-2022 | Class II | Dentemp One Step .077Oz, Sku 902139 | Family Dollar Stores | EMA | |
| Z-1528-2022 | Class II | Veriquick Pregnancy Test 2CT, SKU 903756 | Family Dollar Stores | LCX | |
| Z-1527-2022 | Class II | Veriquick Pregnancy Test 1Ct, Sku 901260, 939504 | Family Dollar Stores | LCX | |
| Z-1526-2022 | Class II | Clearblue Smart Countdown Prgncy Tst 1Ct, Sku-Id 900260 | Family Dollar Stores | LCX | |
| Z-1490-2022 | Class I | Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy... | Medtronic, Inc. | NIK | |
| Z-1489-2022 | Class I | Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1... | Medtronic, Inc. | NIK | |
| Z-1488-2022 | Class I | Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy... | Medtronic, Inc. | NIK | |
| Z-1487-2022 | Class I | Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1... | Medtronic, Inc. | NIK | |
| Z-1486-2022 | Class I | Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy... | Medtronic, Inc. | NIK | |
| Z-1485-2022 | Class I | Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers... | Medtronic, Inc. | LWS | |
| Z-1479-2022 | Class II | Revogene, Catalog no. 610210. IVD test instrument | Meridian Bioscience Inc | OOI | |
| Z-1517-2022 | Class II | (1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per... | Aso LLC | FQM | |
| Z-1424-2022 | Class II | Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum... | Randox Laboratories, Limited | CHH | |
| Z-1395-2022 | Class I | CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor. | Integra LifeSciences Corporation | GWM | |
| Z-1484-2022 | Class II | The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be... | Intuitive Surgical, Inc. | NAY | |
| Z-1376-2022 | Class I | ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167... | Baxter Healthcare Corporation | NEP | |
| Z-1770-2022 | Class II | AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with... | Fresenius Medical Care Renal Therapies Group, LLC | FIP | |
| Z-1769-2022 | Class II | AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use... | Fresenius Medical Care Renal Therapies Group, LLC | FIP | |
| Z-1461-2022 | Class II | etouchus, model no. ETM-G01. Noninvasive Blood glucose meter. | Touch US LLC | NBW |