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 2026-10-22, the FDA export date. FDA medical device recall database

59,544 records, page 622 of 1191

FDA device recalls, page 622 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0315-2016	Class II	ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item...	Ameditech, Inc.	JXM	2015-10-20
Z-0314-2016	Class II	Premier Clia Waived 12 panel Tilt Cup, Item No. C12APC These Drugs of Abuse Tests are...	Ameditech, Inc.	JXM	2015-10-20
Z-0313-2016	Class II	Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs of Abuse Tests...	Ameditech, Inc.	JXM	2015-10-20
Z-0312-2016	Class II	Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pnl Drug Screen...	Ameditech, Inc.	JXM	2015-10-20
Z-0311-2016	Class II	iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel...	Ameditech, Inc.	JXM	2015-10-20
Z-0310-2016	Class II	EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step...	Ameditech, Inc.	JXM	2015-10-20
Z-0309-2016	Class II	DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D; DrugSmart Dip...	Ameditech, Inc.	JXM	2015-10-20
Z-0308-2016	Class II	DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No...	Ameditech, Inc.	JXM	2015-10-20
Z-0307-2016	Class II	DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY)...	Ameditech, Inc.	JXM	2015-10-20
Z-0306-2016	Class II	DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5 These Drugs of Abuse Tests...	Ameditech, Inc.	JXM	2015-10-20
Z-0305-2016	Class II	DrugCheck Pipette 10 Drug Test, Item No. 41025 DC These Drugs of Abuse Tests are one-step...	Ameditech, Inc.	JXM	2015-10-20
Z-0304-2016	Class II	CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No...	Ameditech, Inc.	JXM	2015-10-20
Z-0303-2016	Class II	ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO These Drugs of Abuse Tests are...	Ameditech, Inc.	JXM	2015-10-20
Z-0302-2016	Class II	12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests...	Ameditech, Inc.	JXM	2015-10-20
Z-0301-2016	Class II	11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult...	Ameditech, Inc.	JXM	2015-10-20
Z-0300-2016	Class II	11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI300) w/Adult...	Ameditech, Inc.	JXM	2015-10-20
Z-0299-2016	Class II	10-Panel Pipette Drug Screen, Item No. PSP-10M These Drugs of Abuse Tests are one-step...	Ameditech, Inc.	JXM	2015-10-20
Z-0298-2016	Class II	1 Step 12 Panel Cup, Item No. NBCA-12M-W These Drugs of Abuse Tests are one-step...	Ameditech, Inc.	JXM	2015-10-20
Z-2760-2016	Class II	The system provides the ability to transmit patient data files for storage, viewing and...	Invivo Corporation	MWI	2015-10-19
Z-0276-2016	Class II	Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary...	Synthes (USA) Products LLC	JDQ	2015-10-19
Z-0223-2016	Class II	FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size...	Bard Peripheral Vascular Inc	MIH	2015-10-19
Z-0207-2016	Class II	ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW...	Arrow International LLC (subsidiary of Teleflex Incorporated)	LJS	2015-10-16
Z-0233-2016	Class II	Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile...	Utah Medical Products, Inc	KDD	2015-10-16
Z-0181-2016	Class II	Monaco - Radiation Treatment Planning used to make treatment plans for patients with...	Elekta Limited	MUJ	2015-10-16
Z-0929-2018	Class II	DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number...	Svar Life Science AB	LKJ	2015-10-15
Z-0939-2017	Class II	DR Systems Unity PACS software, now known as Merge Unity PACS software.	Merge Healthcare Incorporated	LLZ	2015-10-15
Z-0281-2016	Class II	Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total...	Howmedica Osteonics Corp	JDI	2015-10-15
Z-0235-2016	Class II	SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical...	Stryker Sustainability Solutions	GFA	2015-10-14
Z-0345-2016	Class II	HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON...	DeRoyal Industries, Inc.	FMT	2015-10-14
Z-0293-2016	Class II	Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following...	TZ Medical Inc.	FRO	2015-10-14
Z-0318-2016	Class II	SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part...	TZ Medical Inc.	FRO	2015-10-14
Z-0277-2016	Class II	Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the...	Teleflex Medical	GBW	2015-10-14
Z-0333-2016	Class II	Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal...	Medtronic, Inc.	NYU	2015-10-14
Z-0332-2016	Class II	Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5...	Medtronic, Inc.	NYU	2015-10-14
Z-0331-2016	Class II	Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5...	Medtronic, Inc.	NYU	2015-10-14
Z-0330-2016	Class II	Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33...	Medtronic, Inc.	NYU	2015-10-14
Z-0329-2016	Class II	Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch...	Medtronic, Inc.	NYU	2015-10-14
Z-0320-2016	Class II	Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC...	Philips North America LLC	MKJ	2015-10-14
Z-0250-2016	Class II	NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery...	Ceterix Orthopedics, Inc.	NBH	2015-10-13
Z-0230-2016	Class I	Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i...	Event Medical Ltd	CBK	2015-10-13
Z-0344-2016	Class II	Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or...	Stryker Medical	FOX	2015-10-13
Z-0239-2016	Class II	Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic...	Siemens Healthcare Diagnostics Inc.	DHX	2015-10-13
Z-0212-2016	Class I	RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra...	Boston Scientific Corporation	MCX	2015-10-09
Z-0211-2016	Class I	RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy...	Boston Scientific Corporation	MCX	2015-10-09
Z-0234-2016	Class II	miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and...	miraDry, Inc.	OUB	2015-10-09
Z-0221-2016	Class II	SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications...	CareFusion 303, Inc	FPA	2015-10-09
Z-0878-2017	Class II	Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.	Merge Healthcare Incorporated	LLZ	2015-10-08
Z-0272-2016	Class II	Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15...	Precision Medical, Inc.	CAN	2015-10-08
Z-0236-2016	Class II	Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm...	Synthes (USA) Products LLC	HRS	2015-10-08
Z-0274-2016	Class II	Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed	Hill-Rom Inc.	FNL	2015-10-07