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Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

29,963medical device recall records

2,598FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1205

29,963 detailed records are currently available in this category.

Medical DeviceMar 25, 2015

Siemens LANTIS Oncology Information System Servers recall — FDA Z-1282-2015

There is a potential safety risk when using LANTIS server software with operating systems with which it has not been validated or released which can lead to an incorrect treatment to the…

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceMar 25, 2015

CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N recall — FDA Z-1298-2015

Products without expiration date have the remote potential for minor burn

Class IIFDA: TerminatedCooperSurgical, Inc.

Medical DeviceMar 25, 2015

Synthes Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral recall — FDA Z-1281-2015

For certain lots, the incorrect raw material of annealed 17-4PH Stainless Steel was used instead of the correct material of heat-treated 304 Stainless Steel. This may lead to…

Class IIFDA: TerminatedSynthes, Inc.

Medical DeviceMar 25, 2015

Siemens Medical Solutions USA E.CAM emission computed tomography system used to detect or recall — FDA Z-1297-2015

Radial motor drives replaced during a customer service action were incorrectly assembled backwards.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceMar 25, 2015

Bard Access Systems BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device recall — FDA Z-1271-2015

Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some…

Class IIFDA: TerminatedBard Access Systems

Medical DeviceMar 25, 2015

St Jude Medical TactiSys Quartz Pack, PN-004 400 recall — FDA Z-1284-2015

A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.

Class IIFDA: TerminatedSt Jude Medical

Medical DeviceMar 25, 2015

Siemens Medical Solutions USA ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A recall — FDA Z-0984-2015

There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceMar 25, 2015

Elekta Precise Treatment Table recall — FDA Z-1238-2015

It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective…

Class IIFDA: TerminatedElekta, Inc.

Medical DeviceMar 25, 2015

Bard Access Systems BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device recall — FDA Z-1273-2015

Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some…

Class IIFDA: TerminatedBard Access Systems

Medical DeviceMar 25, 2015

Siemens Healthcare Diagnostics N Latex IgM; In-vitro diagnostic reagent for the quantitative recall — FDA Z-1289-2015

Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when using some N Latex IgM reagent kit lots 44018, 44019 and 44042.

Class IIIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceMar 25, 2015

Siemens Medical Solutions USA Symbia E is a multi-purpose SPECT system used to detect or recall — FDA Z-1296-2015

Radial motor drives replaced during a customer service action were incorrectly assembled backwards.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceMar 25, 2015

GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC recall — FDA Z-1270-2015

Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).

Class IIFDA: TerminatedGE Healthcare

Medical DeviceMar 25, 2015

GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all recall — FDA Z-1279-2015

GE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG system during a Quality Control check, while the detectors were rotating. No…

Class IIFDA: TerminatedGE Healthcare

Medical DeviceMar 25, 2015

CooperSurgical Fisher Brand Gel Infant Heel Gel Warmers, Cat recall — FDA Z-1299-2015

Products without expiration date have the remote potential for minor burn

Class IIFDA: TerminatedCooperSurgical, Inc.

Medical DeviceMar 25, 2015

Mindray DS USA, Inc. dba Mindray Passport V Monitor, Multiparameter Patient Monitor recall — FDA Z-1280-2015

An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement

Class IIFDA: TerminatedMindray DS USA, Inc. dba Mindray North America

Medical DeviceMar 25, 2015

Materialise N.V Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature recall — FDA Z-1287-2015

Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation…

Class IIFDA: TerminatedMaterialise N.V.

Medical DeviceMar 25, 2015

Bard Access Systems BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device recall — FDA Z-1272-2015

Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some…

Class IIFDA: TerminatedBard Access Systems

Medical DeviceMar 25, 2015

Sybron Dental Specialties Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light recall — FDA Z-1291-2015

Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the…

Class IIFDA: TerminatedSybron Dental Specialties

Medical DeviceMar 25, 2015

Smiths Medical ASD CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24 recall — FDA Z-1286-2015

Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs (Cassette). Some Cassettes may leak at the sealing area of the pump tube and…

Class IIFDA: TerminatedSmiths Medical ASD, Inc.

Medical DeviceMar 25, 2015

Baxter Healthcare The HomeChoice Pro APD System is a peritoneal dialysis system recall — FDA Z-1292-2015

The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects the occluder blade to the manifold causing an unrecoverable system error, and/or…

Class IIFDA: TerminatedBaxter Healthcare Corp.

Medical DeviceMar 25, 2015

Puritan absorbent foam tipped applicator recall — FDA Z-1278-2015

Shaft breaks so that adequate patient specimen sample cannot be obtained.

Class IIFDA: TerminatedPuritan Medical Products Co., LLC

Medical DeviceMar 25, 2015

Stryker Howmedica Osteonics Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The recall — FDA Z-1283-2015

Potential for weld disassociation of the cross pin, which could lead to loose or disassociated trigger mechanism on the Distal Capture Assembly.

Class IIFDA: TerminatedStryker Howmedica Osteonics Corp.

Medical DeviceMar 25, 2015

Med-logics ML 7090 Calibrated LASIK Blade (CLB) recall — FDA Z-1268-2015

The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.

Class IIFDA: TerminatedMed-logics Inc.

Medical DeviceMar 25, 2015

Radiometer Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 recall — FDA Z-1293-2015

Negative drift on QC during in-use lifetime of CREA membranes can be observed.

Class IIFDA: TerminatedRadiometer America Inc.

How to use this medical device recall index

Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.

Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.

What the database can and cannot tell you

This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.