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-2560-2021 | Class II | Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use... | B Braun Medical Inc | FPA | |
| Z-2559-2021 | Class II | Outlook Pump Primary Administration Set w/ micro Tubing for Epidural... | B Braun Medical Inc | FPA | |
| Z-2558-2021 | Class II | Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System... | B Braun Medical Inc | FPA | |
| Z-2557-2021 | Class II | OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety... | B Braun Medical Inc | FPA | |
| Z-2556-2021 | Class II | OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety... | B Braun Medical Inc | FPA | |
| Z-2555-2021 | Class II | PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion... | B Braun Medical Inc | FPA | |
| Z-2554-2021 | Class II | OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System... | B Braun Medical Inc | FPA | |
| Z-2553-2021 | Class II | Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety... | B Braun Medical Inc | FPA | |
| Z-2552-2021 | Class II | OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion... | B Braun Medical Inc | FPA | |
| Z-2551-2021 | Class II | V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System... | B Braun Medical Inc | FPA | |
| Z-2550-2021 | Class II | ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion... | B Braun Medical Inc | FPA | |
| Z-2549-2021 | Class II | Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the... | B Braun Medical Inc | FPA | |
| Z-2548-2021 | Class II | 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook... | B Braun Medical Inc | FPA | |
| Z-2547-2021 | Class II | 60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook... | B Braun Medical Inc | FPA | |
| Z-2546-2021 | Class II | Outlook Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE Y-Sites: single-use for... | B Braun Medical Inc | FPA | |
| Z-2545-2021 | Class II | Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the... | B Braun Medical Inc | FPA | |
| Z-2544-2021 | Class II | 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook... | B Braun Medical Inc | FPA | |
| Z-2400-2021 | Class II | TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be... | Depuy Orthopaedics Inc. | NJL | |
| Z-2399-2021 | Class II | TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be... | Depuy Orthopaedics Inc. | NJL | |
| Z-2398-2021 | Class II | TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be... | Depuy Orthopaedics Inc. | NJL | |
| Z-2397-2021 | Class II | TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be... | Depuy Orthopaedics Inc. | NJL | |
| Z-2396-2021 | Class II | TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be... | Depuy Orthopaedics Inc. | NJL | |
| Z-2395-2021 | Class II | TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be... | Depuy Orthopaedics Inc. | NJL | |
| Z-2394-2021 | Class II | TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be... | Depuy Orthopaedics Inc. | NJL | |
| Z-0256-2022 | Class II | REGARD Vitrectomy Tray | ROi CPS LLC | OJK | |
| Z-0255-2022 | Class II | REGARD Ultrasound Tray | ROi CPS LLC | OIP | |
| Z-0254-2022 | Class II | REGARD Stereotactic Tray | ROi CPS LLC | OIP | |
| Z-0253-2022 | Class II | REGARD Newborn Tray | ROi CPS LLC | MLS | |
| Z-0252-2022 | Class II | REGARD Ear Tray | ROi CPS LLC | OGR | |
| Z-0251-2022 | Class II | REGARD Core Biopsy Tray | ROi CPS LLC | LRO | |
| Z-0250-2022 | Class II | REGARD Basic Cataract tray | ROi CPS LLC | OJK | |
| Z-2496-2021 | Class II | Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these... | AD-Tech Medical Instrument Corp. | IKD | |
| Z-2495-2021 | Class II | Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of... | AD-Tech Medical Instrument Corp. | IKD | |
| Z-2494-2021 | Class II | Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting... | AD-Tech Medical Instrument Corp. | IKD | |
| Z-0032-2022 | Class II | Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT... | Siemens Healthcare Diagnostics Inc. | MMI | |
| Z-0178-2022 | Class II | Bivona Uncuffed Wire Endotracheal Tubes, | Abbott Medical | BTR | |
| Z-0177-2022 | Class II | Bivona Aire-Cuf Endotracheal Tube | Abbott Medical | BTR | |
| Z-2519-2021 | Class II | DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM... | ConvaTec Limited | NAD | |
| Z-0066-2022 | Class II | Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.)... | ZOLL Circulation, Inc. | NCX | |
| Z-0065-2022 | Class II | Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6... | ZOLL Circulation, Inc. | NCX | |
| Z-0064-2022 | Class II | Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.)... | ZOLL Circulation, Inc. | NCX | |
| Z-0063-2022 | Class II | Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6... | ZOLL Circulation, Inc. | NCX | |
| Z-0062-2022 | Class II | Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.) | ZOLL Circulation, Inc. | NCX | |
| Z-0061-2022 | Class II | Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.) | ZOLL Circulation, Inc. | NCX | |
| Z-0060-2022 | Class II | Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.) | ZOLL Circulation, Inc. | NCX | |
| Z-0059-2022 | Class II | Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.) | ZOLL Circulation, Inc. | NCX | |
| Z-0058-2022 | Class II | Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.) | ZOLL Circulation, Inc. | NCX | |
| Z-0057-2022 | Class II | Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange... | ZOLL Circulation, Inc. | NCX | |
| Z-0056-2022 | Class II | Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange... | ZOLL Circulation, Inc. | NCX | |
| Z-0055-2022 | Class II | Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange... | ZOLL Circulation, Inc. | NCX |