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 2026-10-12, the FDA export date. FDA medical device recall database

59,476 records, page 278 of 1190

FDA device recalls, page 278 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2337-2021	Class II	ECHELON MRI System	FUJIFILM Healthcare Americas Corporation	LNH	2021-07-29
Z-0117-2022	Class II	Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig)...	Siemens Healthcare Diagnostics Inc.	CDD	2021-07-28
Z-2612-2021	Class II	Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06...	Corin Limited	MEH	2021-07-28
Z-2611-2021	Class II	Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF...	Corin Limited	MEH	2021-07-28
Z-2610-2021	Class II	Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF...	Corin Limited	MEH	2021-07-28
Z-2609-2021	Class II	Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201...	Corin Limited	MEH	2021-07-28
Z-2608-2021	Class II	Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile...	Corin Limited	MEH	2021-07-28
Z-2607-2021	Class II	Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805...	Corin Limited	MEH	2021-07-28
Z-2606-2021	Class II	Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640...	Corin Limited	MEH	2021-07-28
Z-2605-2021	Class II	Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF...	Corin Limited	MEH	2021-07-28
Z-2604-2021	Class II	Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035...	Corin Limited	MEH	2021-07-28
Z-2603-2021	Class II	Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.	Corin Limited	MEH	2021-07-28
Z-2354-2021	Class II	Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001	Roche Diabetes Care, Inc.	NBW	2021-07-28
Z-2353-2021	Class II	Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers...	Roche Diabetes Care, Inc.	LFR	2021-07-28
Z-2352-2021	Class II	Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001	Roche Diabetes Care, Inc.	LFR	2021-07-28
Z-2351-2021	Class II	Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers...	Roche Diabetes Care, Inc.	LZG	2021-07-28
Z-0030-2022	Class II	Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic...	Contamac Solutions, Inc.	MRC	2021-07-27
Z-0002-2022	Class II	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single...	Bard Peripheral Vascular Inc	FMI	2021-07-27
Z-2410-2021	Class II	Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of...	Versea Diagnostics LLC	QMN	2021-07-27
Z-2409-2021	Class II	Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative...	Versea Diagnostics LLC	QKO	2021-07-27
Z-2408-2021	Class II	FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of...	Versea Diagnostics LLC	QKO	2021-07-27
Z-2407-2021	Class II	CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2...	Versea Diagnostics LLC	QKP	2021-07-27
Z-2405-2021	Class II	Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit...	Clarus Medical, LLC	GEX	2021-07-27
Z-0018-2022	Class II	Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an...	Paltop Advanced Dental Solutions Ltd	NDP	2021-07-26
Z-0017-2022	Class II	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an...	Paltop Advanced Dental Solutions Ltd	NDP	2021-07-26
Z-0016-2022	Class II	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an...	Paltop Advanced Dental Solutions Ltd	NDP	2021-07-26
Z-0015-2022	Class II	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an...	Paltop Advanced Dental Solutions Ltd	NDP	2021-07-26
Z-0014-2022	Class II	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an...	Paltop Advanced Dental Solutions Ltd	NDP	2021-07-26
Z-0013-2022	Class II	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an...	Paltop Advanced Dental Solutions Ltd	NDP	2021-07-26
Z-2472-2021	Class II	Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for...	Abbott Medical	JJE	2021-07-26
Z-2406-2021	Class II	Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10	Elekta Limited	MUJ	2021-07-26
Z-2290-2021	Class II	Trilogy Evo Universal, Product number DS2000X11B	Respironics, Inc.	CBK	2021-07-26
Z-2289-2021	Class II	Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B	Respironics, Inc.	NOU	2021-07-26
Z-2288-2021	Class II	Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B...	Respironics, Inc.	NOU	2021-07-26
Z-2287-2021	Class II	Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B...	Respironics, Inc.	NOU	2021-07-26
Z-2442-2021	Class II	MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only...	Mivi Neuroscience, Inc.	DQY	2021-07-23
Z-2390-2021	Class II	Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400	Aspen Surgical Products, Inc.	CCX	2021-07-23
Z-2389-2021	Class II	Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601)...	Aspen Surgical Products, Inc.	CCX	2021-07-23
Z-2388-2021	Class II	Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401)...	Aspen Surgical Products, Inc.	CCX	2021-07-23
Z-2441-2021	Class II	MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length)...	Mivi Neuroscience, Inc.	DQY	2021-07-23
Z-2335-2021	Class II	AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343	BioMimetic Therapeutics, LLC	NOX	2021-07-23
Z-2387-2021	Class II	Merge Hemo, Software packages 10.2, 10.3, and 10.4	Merge Healthcare Incorporated	DQK	2021-07-23
Z-2328-2021	Class II	TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)	Boston Scientific Corporation	NAW	2021-07-23
Z-2327-2021	Class II	TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)	Boston Scientific Corporation	NAW	2021-07-23
Z-2379-2021	Class II	Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax...	Baxter Healthcare Corporation	KDI	2021-07-22
Z-2378-2021	Class II	Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET)...	Baxter Healthcare Corporation	KDI	2021-07-22
Z-2333-2021	Class II	BD" Mouse IgG2a Isotype Control APC X39 ASR	Becton, Dickinson and Company, BD Biosciences	MVU	2021-07-22
Z-2306-2021	Class II	EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C...	Philips North America LLC	IYN	2021-07-22
Z-1627-2023	Class II	CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayi...	Trophy	OAS	2021-07-21
Z-0122-2022	Class II	MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products...	Implant Resource Inc	HXL	2021-07-21