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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.