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 2026-10-15, the FDA export date. FDA medical device recall database

59,486 records, page 884 of 1190

FDA device recalls, page 884 of 1190
Recall number	Product	Recalling firm	Product code	Initiated
Z-0743-2012	Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable...	GE Healthcare	DPS	2010-09-10
Z-0041-2012	ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601...	Edan Instruments, Inc.	DPS	2010-09-10
Z-2882-2011	DHEA RIA Reagent The DSL8900 DHEA radioimmunoassay is intended for quantitative...	Siemens Healthcare Diagnostics Inc.	JKC	2010-09-09
Z-0160-2012	Microseal Master Cone Part Number: 815-9033 Microseal Master Cone is intended to...	Ormco/Sybronendo	EKM	2010-09-09
Z-0611-2011	RotoProne Therapy System, Model 209500, Device List Number E232632 Product is designed to...	KCI USA, Inc.	IKZ	2010-09-09
Z-0066-2011	Control Syringe, 12ml, CAT No: CCS201E Version B, Sterile R, Merit Medical Systems...	Merit Medical Systems, Inc.	FMF	2010-09-09
Z-0065-2011	Control Syringe, 10ml, CAT No: CCX011 Version A, Sterile R, Merit Medical Systems...	Merit Medical Systems, Inc.	FMF	2010-09-09
Z-0064-2011	Control Syringe, 10ml, CAT No: CCX010E Version B, Sterile R, Merit Medical Systems...	Merit Medical Systems, Inc.	FMF	2010-09-09
Z-0063-2011	Control Syringe, 10ml, CAT No: CCX010 Version B, Sterile R, Merit Medical Systems...	Merit Medical Systems, Inc.	FMF	2010-09-09
Z-0062-2011	Control Syringe, 12ml, CAT No: CCS100 Version B, Sterile R, Merit Medical Systems...	Merit Medical Systems, Inc.	FMF	2010-09-09
Z-0061-2011	Control Syringe, 12ml, CAT No: CCS600 Version B, Sterile R, Merit Medical Systems...	Merit Medical Systems, Inc.	FMF	2010-09-09
Z-0144-2011	AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers...	Siemens Medical Solutions USA, Inc.	IZI	2010-09-09
Z-0158-2011	Baxter Catheter Extension Set, Luer Activated Valve for I.V. Access, Male Luer Lock...	Baxter Healthcare Corporation	FPA	2010-09-09
Z-0157-2011	Baxter Non-DEHP I.V. Catheter T-Connector Extension Set, 6.5" (16.5 cm), 0.5 mL, PosiFlow...	Baxter Healthcare Corporation	FPA	2010-09-09
Z-0156-2011	Baxter Non-DEHP Y-Type Catheter Extension Set, 6.6" (16.8 cm)., 1.1 mL, PosiFlow Positive...	Baxter Healthcare Corporation	FPA	2010-09-09
Z-0155-2011	Baxter Non-DEHP I.V. Catheter Extension Set, 6.0" (15.2 cm), 0.5 mL, PosiFlow Positive...	Baxter Healthcare Corporation	FPA	2010-09-09
Z-0154-2011	Baxter Non-DEHP I.V. Catheter Extension Set, 8.2" (20.9 cm), 0.3 mL, PosiFlow Positive...	Baxter Healthcare Corporation	FPA	2010-09-09
Z-0153-2011	Baxter Micro-Volume Infusion Set, with 27 G x 0.6" (1.5 cm) Needle, 43" (64 cm), 0.24 mL...	Baxter Healthcare Corporation	FPA	2010-09-09
Z-0152-2011	Baxter Micro-Volume Infusion Set, with 27 G x 0.6" (1.5 cm) Needle, 25" (64 cm), 0.18 mL...	Baxter Healthcare Corporation	FPA	2010-09-09
Z-0151-2011	Baxter Interlink System Non-DHEP Extension Set; 8.3" (21.0 cm), Volume 1.4 mL, Large Bore...	Baxter Healthcare Corporation	FPA	2010-09-09
Z-0150-2011	Baxter Clearlink System Non-DEHP 3 Port Adapter, 1.2 mL, 2 Luer Activated Valves for IV...	Baxter Healthcare Corporation	FPA	2010-09-09
Z-0149-2011	Baxter Non-DEHP Y-Type Catheter Extension Set, 5.3" (13.5 cm), 1.0 mL, Male Luer Lock...	Baxter Healthcare Corporation	FPA	2010-09-09
Z-0148-2011	Baxter Clearlink System Non-DEHP Y-Type Catheter Extension Set, 6.5" (16.5 cm), Vol 1.2...	Baxter Healthcare Corporation	FPA	2010-09-09
Z-0022-2011	The BABIX holder is an accessory used with the DigitalDiagnost X-ray system. It is used...	Philips North America LLC	KPR	2010-09-09
Z-0021-2011	The BABIX holder is an accessory used with the BuckyDiagnost X-ray system. It is used to...	Philips North America LLC	KPR	2010-09-09
Z-1969-2011	Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10...	Bio-Rad Laboratories Inc.	LCP	2010-09-08
Z-1257-2011	Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) - Whole Body X-Ray CT Scanner	Canon Medical Systems USA, Inc.	JAK	2010-09-07
Z-0808-2011	Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male...	American Medical Systems, Inc.	FTL	2010-09-07
Z-0147-2011	Recalled chairs include the following: 2008 Model Numbers: 653N - Care Cliner, 654N...	Champion Mfg, Inc.	INM	2010-09-07
Z-0321-2011	Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma...	BioHorizons Implant Systems Inc	DZE	2010-09-07
Z-0109-2011	in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges...	Bio-Rad Laboratories Inc.	LCP	2010-09-07
Z-0011-2011	MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286...	Maquet Cardiovascular Us Sales, LLC	DWE	2010-09-07
Z-0068-2011	Architect Tacrolimus Reagent Kit; an in-vitro diagnostic chemiluminescent microparticle...	Abbott Medical	MLM	2010-09-07
Z-0621-2011	ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5, Sterile R, CE...	Ansell Healthcare Products LLC	KGO	2010-09-03
Z-0990-2011	Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0615, Size...	Southmedic Inc.	GDX	2010-09-03
Z-0989-2011	Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0611, Size...	Southmedic Inc.	GDX	2010-09-03
Z-0988-2011	Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0610, Size...	Southmedic Inc.	GDX	2010-09-03
Z-0369-2011	GE BrightSpeed Excel/Edge/Elite Select / Elite CT Scanner System, models 2377708-560...	GE Healthcare	JAK	2010-09-03
Z-0368-2011	GE LightSpeed VCT Scanner System, models 5212920-300, 5212920-310, 5311595-10. Composed...	GE Healthcare	JAK	2010-09-03
Z-0092-2011	Six Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station...	Wilson-Cook Medical Inc.	MND	2010-09-03
Z-0091-2011	Ten Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station...	Wilson-Cook Medical Inc.	FHN	2010-09-03
Z-0070-2011	Baxter Interlink System Buretrol Solution Set, 83" (2.1 m), 150 mL Burette Drip Chamber...	Baxter Healthcare Corporation	FPA	2010-09-03
Z-0105-2011	LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single stay safe...	Fresenius Medical Care Renal Therapies Group, LLC	FKX	2010-09-03
Z-0104-2011	LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors...	Fresenius Medical Care Renal Therapies Group, LLC	FKX	2010-09-03
Z-0103-2011	LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors...	Fresenius Medical Care Renal Therapies Group, LLC	FKX	2010-09-03
Z-0076-2011	Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class...	Elekta Limited	IYE	2010-09-02
Z-2608-2010	Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, Vascular Solutions...	Vascular Solutions LLC	DQO	2010-09-02
Z-2594-2010	Stryker PainPump2 BlockAid Demo 400 mL PainPump for Continuous Nerve Block, Non-sterile...	Stryker Corp.	FRN	2010-09-02
Z-2593-2010	Stryker PainPump2 BlockAid 400 mL PainPump for Continuous Nerve Block, sterile, REF...	Stryker Corp.	FRN	2010-09-02
Z-2592-2010	Stryker PainPump2 400 mL PainPump with Luer Lock Tubing Set, sterile, REF 540-350...	Stryker Corp.	FRN	2010-09-02