Browse Device Recalls
2,939 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,939 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 2,939 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 18, 2014 | Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiratio... | The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a sa... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 18, 2014 | Multi-Lumen Central Venous Catheterization Kit | Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot numbe... | Class II | Arrow International Inc |
| Sep 17, 2014 | Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094... | The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not b... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 15, 2014 | ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidura... | Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AF... | Class II | Arrow International Inc |
| Sep 2, 2014 | Siemens Ysio Max system The Ysio Max is a radiographic system used in hospit... | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 2, 2014 | DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm par... | DePuy Synthes is initiating a voluntary medical device recall of certain lots of the TI Vectra Pl... | Class II | Synthes, Inc. |
| Sep 2, 2014 | Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detecto... | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 2, 2014 | Siemens Luminos Agile Max system The Luminos Agile is intended to be used a... | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 2, 2014 | Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to... | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 28, 2014 | Bionector Needleless connector. Bionector is a multi-purpose catheter accesso... | Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needlel... | Class II | Vygon Corporation |
| Aug 27, 2014 | The Ysio Systems with software version VC10 The Ysio enables radiographic ... | Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 12, 2014 | AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Lum... | It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 o... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 12, 2014 | eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA... | Two (2) failures of the spring link components within the articulated arm assembly. The spring li... | Class II | Gendex Corp |
| Aug 6, 2014 | B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices... | The primary packaging label (inner pouch label) indicates that the package contents are Catalog I... | Class II | B. Braun Medical, Inc. |
| Aug 6, 2014 | Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Me... | The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline F... | Class II | Arrow International Inc |
| Aug 4, 2014 | Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is i... | The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM. | Class II | Medical Components, Inc dba MedComp |
| Jul 30, 2014 | Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container ... | Integra LifeSciences has identified through an internal investigation that some colored lids for ... | Class II | Integra York PA, Inc |
| Jul 7, 2014 | Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF ... | It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 1, 2014 | Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. ... | The blood pressure (BP) circuit occasionally fails to inflate the blood pressure cuff and the BP ... | Class II | Ansar Group, Inc. Dba Ansar Medical Technologie... |
| Jun 30, 2014 | Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set | A screw set was returned from the field for destruction after being exposed to flood water, which... | Class II | Synthes, Inc. |
| Jun 30, 2014 | Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Pi... | Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A ... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 17, 2014 | Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMEN... | Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncolo... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 13, 2014 | Titan T 5K Motor Product Usage: Low-speed motor is used with various att... | The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded i... | Class II | Dental EZ Group Star Dental Division |
| Jun 13, 2014 | Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable p... | Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4... | Class II | Aesculap, Inc. |
| Jun 10, 2014 | Animas Vibe Insulin Infusion Pump. This product is indicated for continuou... | Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was inco... | Class II | Animas Corporation |
| Jun 5, 2014 | AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee /... | There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 5, 2014 | Calcium Hydroxide Powder, USP For use in root canal therapy by health care... | One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed... | Class II | Axcentria Pharmaceuticals, LLC |
| Jun 5, 2014 | Artis zee and Artis zeego systems. x-ray, angiographic system | There is a potential problem with Artis zee and Artis zeego systems running software version VC21... | Class II | Siemens Medical Solutions USA, Inc |
| May 29, 2014 | Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius ... | The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found... | Class II | Synthes, Inc. |
| May 29, 2014 | STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22... | Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled... | Class II | B. Braun Medical, Inc. |
| May 28, 2014 | Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are inten... | The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about vi... | Class I | Childrens Medical Ventures |
| May 28, 2014 | Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic... | A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field... | Class II | Siemens Medical Solutions USA, Inc |
| May 19, 2014 | Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw Syste... | Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression ... | Class II | Small Bone Innovations |
| May 15, 2014 | Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use o... | An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address ... | Class II | Siemens Medical Solutions USA, Inc |
| May 15, 2014 | Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming... | All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the pack... | Class II | Synthes, Inc. |
| May 13, 2014 | DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep... | A limited number of DV5x Series CPAP units were manufactured and shipped without the serial numbe... | Class III | DeVilbiss Healthcare LLC |
| May 9, 2014 | Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobil... | There is a potential fire hazard of certain Lithium-Ion batteries in the computers used in the or... | Class II | Siemens Medical Solutions USA, Inc |
| May 9, 2014 | Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems ar... | Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generato... | Class II | Siemens Medical Solutions USA, Inc |
| May 6, 2014 | Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; L... | There is a potential risk when using LANTIS OIS System client software with operating systems for... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 29, 2014 | Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2... | Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use. | Class II | Synthes, Inc. |
| Apr 29, 2014 | Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infan... | The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring... | Class II | Childrens Medical Ventures |
| Apr 25, 2014 | MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis... | There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monit... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 24, 2014 | MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic r... | Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may ha... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 22, 2014 | Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Sh... | It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter ... | Class II | Synthes, Inc. |
| Apr 21, 2014 | Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt ... | AIC (USA) received information regarding 3 complaints in which the deflector did not move freely ... | Class II | Aesculap, Inc. |
| Apr 16, 2014 | DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies an... | DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction Syste... | Class I | Synthes, Inc. |
| Apr 15, 2014 | ReTurn 7500/7500 Aid, transfer | During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw an... | Class II | Handicare USA, Inc. |
| Apr 14, 2014 | Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introdu... | Arrow is recalling the Arrow¿ Percutaneous Sheath Introducer Kits due to dilator tip damage noted... | Class II | Arrow International Inc |
| Apr 11, 2014 | AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a... | It was determined that under rare environmental conditions (i.e., extremely dry air in combinatio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 10, 2014 | Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixatio... | Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result... | Class II | Synthes, 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.