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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.

28,992medical device recall records

2,381FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1055

28,992 detailed records are currently available in this category.

Medical DeviceAug 3, 2016

Ortho-Clinical Diagnostics VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 recall — FDA Z-2273-2016

Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 Chemistry…

Class IIFDA: TerminatedOrtho-Clinical Diagnostics

Medical DeviceJul 27, 2016

The Anspach Effort Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for recall — FDA Z-2253-2016

The graphics at the attachment interface indicating locked and unlocked position are reversed.

Class IIFDA: TerminatedThe Anspach Effort, Inc.

Medical DeviceJul 27, 2016

WalkMed Infusion T095-120 IV Set with 1.2 Micron Filter recall — FDA Z-2228-2016

WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

Class IIFDA: TerminatedWalkMed Infusion, LLC

Medical DeviceJul 27, 2016

WalkMed Infusion The pump recall — FDA Z-2220-2016

WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and…

Class IIFDA: TerminatedWalkMed Infusion, LLC

Medical DeviceJul 27, 2016

Terumo Cardiovascular Systems Sarns TCM; The Sarns Temperature Control and Monitor unit recall — FDA Z-2208-2016

Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205)…

Class IIFDA: TerminatedTerumo Cardiovascular Systems Corporation

Medical DeviceJul 27, 2016

CSL Behring GmbH Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS), Device Listing recall — FDA Z-2241-2016

Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed.

Class IIFDA: TerminatedCSL Behring GmbH

Medical DeviceJul 27, 2016

Stryker Instruments Div. of Stryker 2.3MM Tapered Router, Product Number 5407-FA2-023 A recall — FDA Z-2238-2016

A variation in flute depth on the routers was observed. The variation in flute depth may cause the routers to be more susceptible to breakages. Risk to Health: Injury to critical soft…

Class IIFDA: TerminatedStryker Instruments Div. of Stryker Corporation

Medical DeviceJul 27, 2016

WalkMed Infusion T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & recall — FDA Z-2235-2016

WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

Class IIFDA: TerminatedWalkMed Infusion, LLC

Medical DeviceJul 27, 2016

WalkMed Infusion T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap recall — FDA Z-2234-2016

WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

Class IIFDA: TerminatedWalkMed Infusion, LLC

Medical DeviceJul 27, 2016

WalkMed Infusion The pump recall — FDA Z-2219-2016

WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and…

Class IIFDA: TerminatedWalkMed Infusion, LLC

Medical DeviceJul 27, 2016

WalkMed Infusion T090-000 90" 20 Drop IV Admin Set recall — FDA Z-2223-2016

WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

Class IIFDA: TerminatedWalkMed Infusion, LLC

Medical DeviceJul 27, 2016

Centurion Medical Products Convenience Kits from Centurion that contain a Medtronic/Covidien recall — FDA Z-2250-2016

Kits from Centurion contain a Medtronic/Covidien Light Glove that is being recalled by the manufacturer, Medtronic. According to the notice received from Medtronic, the recall was initiated…

Class IIFDA: TerminatedCenturion Medical Products Corporation

Medical DeviceJul 27, 2016

Terumo Cardiovascular Systems Preamendments device-Sarns Dual Cooler-Heater recall — FDA Z-2210-2016

Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Inter chlor sanitizer (Product Code…

Class IIFDA: TerminatedTerumo Cardiovascular Systems Corporation

Medical DeviceJul 27, 2016

WalkMed Infusion T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and recall — FDA Z-2231-2016

WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

Class IIFDA: TerminatedWalkMed Infusion, LLC

Medical DeviceJul 27, 2016

WalkMed Infusion T100-022F with 0.22 micron filter and FP Clip recall — FDA Z-2232-2016

WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

Class IIFDA: TerminatedWalkMed Infusion, LLC

Medical DeviceJul 27, 2016

Synthes (USA) Products Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) recall — FDA Z-2214-2016

DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (Part # 03.037.017) may have been manufactured with a slightly larger than specified outer…

Class IIFDA: TerminatedSynthes (USA) Products LLC

Medical DeviceJul 27, 2016

WalkMed Infusion T100-120F with 1.2 micron filter and FP Clip recall — FDA Z-2233-2016

WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

Class IIFDA: TerminatedWalkMed Infusion, LLC

Medical DeviceJul 27, 2016

Becton, Dickinson and Company, BD Biosciences BD Trucount Tubes recall — FDA Z-2252-2016

One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the product.

Class IIFDA: TerminatedBecton, Dickinson and Company, BD Biosciences

Medical DeviceJul 27, 2016

Nobel Biocare Usa Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select recall — FDA Z-2237-2016

Incorrect top label on an implant package.

Class IIFDA: TerminatedNobel Biocare Usa LLC

Medical DeviceJul 27, 2016

Bayer Healthcare Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System recall — FDA Z-2244-2016

Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner.

Class IIFDA: TerminatedBayer Healthcare

Medical DeviceJul 27, 2016

Terumo Cardiovascular Systems HX2" Temperature Management Systems recall — FDA Z-2207-2016

Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205)…

Class IIFDA: TerminatedTerumo Cardiovascular Systems Corporation

Medical DeviceJul 27, 2016

WalkMed Infusion T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve recall — FDA Z-2225-2016

WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

Class IIFDA: TerminatedWalkMed Infusion, LLC

Medical DeviceJul 27, 2016

WalkMed Infusion T100-000VF, IV Set with Lower Y Site and Free Flow Clip recall — FDA Z-2230-2016

WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

Class IIFDA: TerminatedWalkMed Infusion, LLC

Medical DeviceJul 27, 2016

WalkMed Infusion T030-000 -30" 20 Drop IV Admin Secondary Set recall — FDA Z-2222-2016

WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

Class IIFDA: TerminatedWalkMed Infusion, LLC

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.