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 595 of 1191

FDA device recalls, page 595 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2236-2016	Class II	GE Inspection Technologies, LP - Phoenix v\|tome\|x m240 cabinet x-ray systems. A...	GE Inspection Technologies, LP	RCE	2016-03-02
Z-2089-2016	Class II	IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED...	Cmp Industries, LLC	EBI	2016-03-02
Z-1521-2016	Class II	Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM...	Siemens Medical Solutions USA, Inc.	JAK	2016-03-02
Z-1520-2016	Class II	Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body...	Siemens Medical Solutions USA, Inc.	JAK	2016-03-02
Z-1519-2016	Class II	Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body...	Siemens Medical Solutions USA, Inc.	JAK	2016-03-02
Z-1518-2016	Class II	Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body...	Siemens Medical Solutions USA, Inc.	JAK	2016-03-02
Z-1347-2016	Class II	SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic...	GE Healthcare	LNH	2016-03-01
Z-1394-2016	Class II	VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is...	Alcon Laboratories	NFG	2016-03-01
Z-2725-2017	Class III	Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and...	Ams Diagnostics	JIX	2016-02-29
Z-1320-2016	Class II	Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of...	Medtronic, Inc.	OHG	2016-02-29
Z-1188-2016	Class II	The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to...	Richard Wolf Medical Instruments Corp.	FWE	2016-02-29
Z-1245-2016	Class II	RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing...	Nidek Incorporated	HKN	2016-02-29
Z-1333-2016	Class II	ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for...	KARL STORZ Endovision, Inc.	MNL	2016-02-29
Z-1092-2017	Class II	Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The...	Roche Diagnostics GmbH	NQD	2016-02-26
Z-1299-2016	Class II	system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141...	Siemens Medical Solutions USA, Inc.	IZI	2016-02-26
Z-1263-2016	Class II	The Symbia gamma camera system Product Usage: The Symbia gamma camera system is a...	Siemens Medical Solutions USA, Inc.	KPS	2016-02-26
Z-1262-2016	Class II	The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT...	Siemens Medical Solutions USA, Inc.	KPS	2016-02-26
Z-1092-2016	Class II	Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians...	GE Healthcare	MHX	2016-02-26
Z-1324-2016	Class II	Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic...	Fresenius Medical Care Renal Therapies Group, LLC	FJI	2016-02-26
Z-1261-2016	Class II	31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber...	Abbott Medical	ONB	2016-02-25
Z-1260-2016	Class II	30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber...	Abbott Medical	ONB	2016-02-25
Z-1259-2016	Class II	30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port...	Abbott Medical	ONB	2016-02-25
Z-1258-2016	Class II	30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros...	Abbott Medical	ONB	2016-02-25
Z-1257-2016	Class II	110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber...	Abbott Medical	ONB	2016-02-25
Z-1256-2016	Class II	30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2...	Abbott Medical	ONB	2016-02-25
Z-1255-2016	Class II	30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber...	Abbott Medical	ONB	2016-02-25
Z-1254-2016	Class II	74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile...	Abbott Medical	ONB	2016-02-25
Z-1315-2016	Class II	TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high...	Scottcare Corporation	DSI	2016-02-25
Z-1485-2017	Class II	PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external...	Purewick Corporation	NNW	2016-02-24
Z-2188-2016	Class II	Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10...	Canon Medical Systems USA, Inc.	OWB	2016-02-24
Z-1647-2016	Class I	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit...	bioMerieux, Inc.	LTW	2016-02-24
Z-1646-2016	Class I	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit...	bioMerieux, Inc.	LTW	2016-02-24
Z-1645-2016	Class I	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit...	bioMerieux, Inc.	LTW	2016-02-24
Z-1644-2016	Class I	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit...	bioMerieux, Inc.	LTW	2016-02-24
Z-1643-2016	Class I	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit...	bioMerieux, Inc.	LTW	2016-02-24
Z-1642-2016	Class I	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit...	bioMerieux, Inc.	LTW	2016-02-24
Z-1641-2016	Class I	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit...	bioMerieux, Inc.	LTW	2016-02-24
Z-1640-2016	Class I	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit...	bioMerieux, Inc.	LTW	2016-02-24
Z-1596-2016	Class II	VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit...	bioMerieux, Inc.	LON	2016-02-24
Z-1232-2016	Class II	syngo X Workplace is a medical workstation for real-time viewing, image manipulation...	Siemens Medical Solutions USA, Inc.	LLZ	2016-02-24
Z-1586-2016	Class II	Analyst MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API...	AB Sciex, LLC	DOP	2016-02-24
Z-1639-2016	Class I	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit...	bioMerieux, Inc.	LTW	2016-02-24
Z-1298-2016	Class II	Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose...	Ossur Iceland ehf.	IQK	2016-02-24
Z-1297-2016	Class II	Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide...	Ossur Iceland ehf.	IQI	2016-02-24
Z-1296-2016	Class II	Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide...	Ossur Iceland ehf.	IQI	2016-02-24
Z-1295-2016	Class II	Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to...	Ossur Iceland ehf.	IQI	2016-02-24
Z-1294-2016	Class II	Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide...	Ossur Iceland ehf.	IQI	2016-02-24
Z-1293-2016	Class II	Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black	Ossur Iceland ehf.	IPY	2016-02-24
Z-1292-2016	Class II	Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the...	Ossur Iceland ehf.	ITW	2016-02-24
Z-1291-2016	Class II	Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and...	Ossur Iceland ehf.	ITW	2016-02-24