Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 3,313 FDA device recalls in 2017.

Clear
DateProductReasonClassFirm
Jun 5, 2017 Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Jun 5, 2017 COMP 12MM HUM FRAC STEM MACRO, model # 11-113562 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Lateral Troch Plate Full Crimp - 254mm, model # 350838 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model ... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Jun 5, 2017 M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter ... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 c... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 2, 2017 St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Cur... Inadequate seal due to lack of adhesive glue Class I Sterilmed Inc
Jun 2, 2017 Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 Label on product box contains the incorrect reference #317-09 while the shelf box label with barc... Class III C.R. Bard, Inc.
Jun 2, 2017 Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO ... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Jun 2, 2017 BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension... Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the prod... Class II C.R. Bard, Inc.
Jun 2, 2017 Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Pro... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Jun 2, 2017 Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO ... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Jun 2, 2017 Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Pro... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Jun 2, 2017 Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, P... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Jun 2, 2017 Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Pro... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Jun 1, 2017 Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000. Product Usage: Intended for ... Seal integrity of the Tissu-Trans product sterile packages cannot be assured. Class II Shippert Medical Technologies
Jun 1, 2017 Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000. Product Usage: Intended for ... Seal integrity of the Tissu-Trans product sterile packages cannot be assured. Class II Shippert Medical Technologies
Jun 1, 2017 Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above... Label on the affected devices incorrectly identifies the injection location as "above" the ball... Class II Boston Scientific Corporation
Jun 1, 2017 VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/... Potential inaccurate calibration by service depot repair, which could contribute to patients bein... Class II Solta Medical Inc
Jun 1, 2017 Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central V... There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of ... Class II Arrow International Inc
Jun 1, 2017 VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300V... Potential inaccurate calibration by service depot repair, which could contribute to patients bein... Class II Solta Medical Inc
Jun 1, 2017 ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (... There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of ... Class II Arrow International Inc
Jun 1, 2017 Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for ... Seal integrity of the Tissu-Trans product sterile packages cannot be assured. Class II Shippert Medical Technologies
Jun 1, 2017 Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below... Label on the affected devices incorrectly identifies the injection location as "above" the ball... Class II Boston Scientific Corporation
Jun 1, 2017 BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is desi... Potential unexpected movement of robot arm Class III Becton Dickinson & Co.
Jun 1, 2017 Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat tr... Seal integrity of the Tissu-Trans product sterile packages cannot be assured. Class II Shippert Medical Technologies
Jun 1, 2017 da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical Syste... da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentiall... Class II Intuitive Surgical, Inc.
Jun 1, 2017 MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable F... The sleeve seam of the breathable material was found to have inconsistent sealing, which has the ... Class II Master & Frank (Pinghu) Co., Ltd.
Jun 1, 2017 BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usa... Intact carton revealed presence of shredded burn sheets Class II Dukal Corp.
Jun 1, 2017 ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is in... There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of ... Class II Arrow International Inc
Jun 1, 2017 ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is in... There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of ... Class II Arrow International Inc
Jun 1, 2017 Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat tr... Seal integrity of the Tissu-Trans product sterile packages cannot be assured. Class II Shippert Medical Technologies
Jun 1, 2017 Tissu-Trans Filtron 250, 3-TT-FILTRON 250. Product Usage: Intended for fat ... Seal integrity of the Tissu-Trans product sterile packages cannot be assured. Class II Shippert Medical Technologies
Jun 1, 2017 Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fa... Seal integrity of the Tissu-Trans product sterile packages cannot be assured. Class II Shippert Medical Technologies
May 31, 2017 PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collec... PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pac... Class III PerkinElmer Health Sciences, Inc.
May 31, 2017 SoftLab Software Laboratory information system to be used in a medical res... Display of lab results based on incorrect LOINC code/test descriptions for tests that were perfor... Class II Soft Computer Consultants, Inc.
May 31, 2017 3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 0... Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibia... Class II Encore Medical, Lp
May 31, 2017 BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: Thes... Hub damage resulting in breakage and/or leakage during use. Class II Becton Dickinson & Company
May 31, 2017 Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 7122... Tube arm assembly could fall down due to cracked welding joints Class II Philips Electronics North America Corporation
May 31, 2017 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01... Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibia... Class II Encore Medical, Lp
May 30, 2017 LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971... The incorrect Loctite adhesive was used to assemble the impactor heads. Class II Smith & Nephew, Inc.
May 30, 2017 Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is... The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... Class II ICU Medical, Inc.
May 30, 2017 PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check... The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... Class II ICU Medical, Inc.
May 30, 2017 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple... The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... Class II ICU Medical, Inc.
May 30, 2017 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, N... The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... Class II ICU Medical, Inc.
May 30, 2017 28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, ... The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... Class II ICU Medical, Inc.
May 30, 2017 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 N... The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... Class II ICU Medical, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.