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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.

29,496medical device recall records

2,407FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1139

29,496 detailed records are currently available in this category.

Medical DeviceNov 4, 2015

Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold recall — FDA Z-0192-2016

The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.

Class IIFDA: TerminatedSynthes (USA) Products LLC

Medical DeviceNov 4, 2015

Abbott Laboratories ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In recall — FDA Z-0163-2016

Incorrect tubing.

Class IIFDA: TerminatedAbbott Laboratories, Inc.

Medical DeviceNov 4, 2015

Integra Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and recall — FDA Z-0193-2016

Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Injection, USP, 10 mg/mL, Lot 44-359-DK. Hospira Inc. is recalling vials of Lot 44-359-DK, 1%…

Class IIFDA: TerminatedIntegra LifeSciences Corp. d.b.a. Integra Pain…

Medical DeviceOct 28, 2015

ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral recall — FDA Z-0138-2016

May contain small amounts of ethylene glycol residue

Class IIFDA: TerminatedConforMIS, Inc.

Medical DeviceOct 28, 2015

Innovative Sterlization Technologies OneTray Sealed Sterilization Containers Product Usage recall — FDA Z-0153-2016

The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at 270 degrees F instead of Steam Gravity 17 - 34 minutes at 270 degrees F.

Class IIFDA: TerminatedInnovative Sterlization Technologies LLC

Medical DeviceOct 28, 2015

ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee recall — FDA Z-0146-2016

May contain small amounts of ethylene glycol residue

Class IIFDA: TerminatedConforMIS, Inc.

Medical DeviceOct 28, 2015

Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number recall — FDA Z-0155-2016

Sterility of device is compromised due to breach in the packaging

Class IIFDA: TerminatedSmith & Nephew, Inc., Endoscopy Div.

Medical DeviceOct 28, 2015

Philips Medical Systems All Philips Ingenia, Intera, Achieva and Multiva MR systems using recall — FDA Z-0135-2016

In spine clinical workflows, cross reference lines may be used to determine the position of slices. In cases, where MobiView fused Images are used to show the cross reference lines, the…

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Medical DeviceOct 28, 2015

ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial recall — FDA Z-0141-2016

May contain small amounts of ethylene glycol residue

Class IIFDA: TerminatedConforMIS, Inc.

Medical DeviceOct 28, 2015

ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral recall — FDA Z-0140-2016

May contain small amounts of ethylene glycol residue

Class IIFDA: TerminatedConforMIS, Inc.

Medical DeviceOct 28, 2015

Elekta XiO Radiation Treatment Planning System recall — FDA Z-0130-2016

Incorrect Treatment Delivery Using Third Party Fixed Wedges.

Class IIFDA: TerminatedElekta, Inc.

Medical DeviceOct 28, 2015

Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number recall — FDA Z-0156-2016

Sterility of device is compromised due to breach in the packaging

Class IIFDA: TerminatedSmith & Nephew, Inc., Endoscopy Div.

Medical DeviceOct 28, 2015

Cardinal Health Ambitex NMD400 Nitrile Exam Gloves size medium recall — FDA Z-0133-2016

Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by…

Class IIFDA: TerminatedCardinal Health

Medical DeviceOct 28, 2015

Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number recall — FDA Z-0157-2016

Sterility of device is compromised due to breach in the packaging

Class IIFDA: TerminatedSmith & Nephew, Inc., Endoscopy Div.

Medical DeviceOct 28, 2015

Smiths Medical ASD PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree recall — FDA Z-0152-2016

The label on the lid stock of the individual needle packages for a portion of Lot number 46262 contains the incorrect part number, part number description and product image. The part number…

Class IIFDA: TerminatedSmiths Medical ASD, Inc.

Medical DeviceOct 28, 2015

Encore Medical AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid recall — FDA Z-0131-2016

Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.

Class IIFDA: TerminatedEncore Medical, Lp

Medical DeviceOct 28, 2015

Biomet Microfixation Neuro Combo Set Case The cases hold surgical instrumentation in place recall — FDA Z-0136-2016

The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.

Class IIFDA: TerminatedBiomet Microfixation, LLC

Medical DeviceOct 28, 2015

ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial recall — FDA Z-0143-2016

May contain small amounts of ethylene glycol residue

Class IIFDA: TerminatedConforMIS, Inc.

Medical DeviceOct 28, 2015

ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT recall — FDA Z-0147-2016

May contain small amounts of ethylene glycol residue

Class IIFDA: TerminatedConforMIS, Inc.

Medical DeviceOct 28, 2015

Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number recall — FDA Z-0158-2016

Sterility of device is compromised due to breach in the packaging

Class IIFDA: TerminatedSmith & Nephew, Inc., Endoscopy Div.

Medical DeviceOct 28, 2015

ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee recall — FDA Z-0145-2016

May contain small amounts of ethylene glycol residue

Class IIFDA: TerminatedConforMIS, Inc.

Medical DeviceOct 28, 2015

ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED recall — FDA Z-0144-2016

May contain small amounts of ethylene glycol residue

Class IIFDA: TerminatedConforMIS, Inc.

Medical DeviceOct 28, 2015

Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066 recall — FDA Z-0149-2016

The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the…

Class IIFDA: TerminatedNatus Medical Inc.

Medical DeviceOct 28, 2015

Synthes (USA) Products 5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm recall — FDA Z-0134-2016

This product was produced using a finishing process not identified as part of the manufacturing specification. The process used with the lots subject to this Recall was a bead blast…

Class IIFDA: TerminatedSynthes (USA) Products 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.