Browse Device Recalls
2,907 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,907 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 2,907 FDA device recalls in 2015.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 3, 2015 | Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System ... | Hole elongation in the telescoping load frame channel. A hole elongation could affect the ability... | Class II | Ferno-Washington Inc |
| Jul 31, 2015 | AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.... | AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... | Class II | Boston Scientific Corporation |
| Jul 31, 2015 | Siemens Symbia T Series, a radiological imaging system that is a combination ... | Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbi... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 31, 2015 | Siemens Intevo Series system, a radiological imaging system that is a combina... | Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbi... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 31, 2015 | Siemens Symbia S Series system, a diagnostic analog or digital detector based... | Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbi... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 31, 2015 | 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot ... | Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specifica... | Class II | Trilliant Surgical Ltd. |
| Jul 31, 2015 | Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product ... | Infant Heel warmers may break during activation resulting in spillage of the contents on patients... | Class II | Covidien LLC |
| Jul 31, 2015 | AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized ... | AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... | Class II | Boston Scientific Corporation |
| Jul 31, 2015 | Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Produc... | Infant Heel warmers may break during activation resulting in spillage of the contents on patients... | Class II | Covidien LLC |
| Jul 31, 2015 | Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Ap... | Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power... | Class II | Applied Medical Resources Corp |
| Jul 31, 2015 | AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog N... | AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... | Class II | Boston Scientific Corporation |
| Jul 31, 2015 | Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. ... | Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restr... | Class II | Edward Lifesciences, Llc |
| Jul 31, 2015 | AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, S... | AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... | Class II | Boston Scientific Corporation |
| Jul 30, 2015 | PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeut... | the catheter peel-away component hub tabs may prematurely detach. One injury reported. | Class II | Arrow International Inc |
| Jul 30, 2015 | Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / Ver... | There is a probability the hand piece may operate inconsistently and unpredictably during the mor... | Class II | Lumenis |
| Jul 30, 2015 | Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Comp... | saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the cath... | Class II | Arrow International Inc |
| Jul 30, 2015 | AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated,... | Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks... | Class II | Beckman Coulter Inc. |
| Jul 30, 2015 | AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated... | Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks... | Class II | Beckman Coulter Inc. |
| Jul 30, 2015 | AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated,... | Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks... | Class II | Beckman Coulter Inc. |
| Jul 29, 2015 | NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece MDI Ad... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous de... | MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexe... | Class II | Biomet 3i, LLC |
| Jul 29, 2015 | KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Produc... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Closed Suction System for Adults, 14 F, Elbow, D-Tip (Product Code 2... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Produc... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Produ... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also know... | The last hole on certain VEPTR Inferior Cradles may be partially formed. Fully lengthening the c... | Class II | Synthes (USA) Products LLC |
| Jul 29, 2015 | NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, Directional T... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, 1... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | NICO Myriad Console Model number NN-7000 The Myriad System is a surgical... | Two cables within the console were inadvertently twisted during manufacturing. The individual wir... | Class II | Nico Corp. |
| Jul 29, 2015 | KimVent* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155);... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece, 12 in Tracheos... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Closed Suction Systems for Adults, 14 F, Qwik Clip (Product Code 227... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109)... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Multi-Access Port Closed Suction System for Adults, Endotracheal, DS... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product ... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Pro... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Closed Suction System for Adults, 14 F, D-Tip, T-Piece (Product Code... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Closed Suction System for Adults, 14 F, T-Piece, MDI (Product Code 8... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Prod... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Co... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product C... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Prod... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216); Ki... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, 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.