Browse Device Recalls
2,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,969 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 2,969 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 4, 2013 | Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berma... | The product specifications sheet, part of the Instructions for Use (IFU), for the specified produ... | Class II | Arrow International Inc |
| Mar 1, 2013 | Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to... | There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over t... | Class II | B. Braun Medical, Inc. |
| Feb 28, 2013 | Siemens Mammomat Inspiration - full-field digital mammography Product Usa... | Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 22, 2013 | Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: ... | The Trial Head may come loose from the implant stem during manipulation of the arm during surgery... | Class II | Synthes USA HQ, Inc. |
| Feb 22, 2013 | Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000... | The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to th... | Class II | Synthes USA HQ, Inc. |
| Feb 4, 2013 | The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep... | The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath... | Class II | Arrow International Inc |
| Jan 31, 2013 | Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Pr... | During the course of product monitoring, Siemens became aware of a tolerance problem in the power... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 24, 2013 | Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC345... | Firm was made aware of incidents relating to the difficulty of properly engaging and securing the... | Class II | Stelkast Co |
| Jan 21, 2013 | Artis zee systems x-ray, angiographic system | The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135,... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 18, 2013 | Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical... | The bipolar energy did not stop after release of the foot pedal. | Class II | Aesculap, Inc. |
| Jan 15, 2013 | Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos... | Siemens has become aware of a potential malfunction and possible hazard to patients and staff whe... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 11, 2013 | Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number ... | This recall is being initiated in response to complaints received where it was reported that the ... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Large Combination Clamp/Large External Fixation System, Part Number 390.005 ... | The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm socket... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. Fo... | There is the potential for the anterior footplates to not fit onto the Titanium Midface Distracto... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Par... | It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to ... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Flexible Grip which is part of the Synthes Universal Nail System. Indicate... | Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part ... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular ... | It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to ... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, P... | It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Pa... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Par... | It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to ... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread L... | Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly et... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also kn... | The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Den... | Class II | Synthes USA HQ, Inc. |
| Jan 4, 2013 | The product is labeled in part "***Surgical Laser Technologies, Inc. Montgome... | Firm became aware that some products within the specified lot may not have been sealed appropriat... | Class II | PhotoMedex, Inc. |
| Jan 3, 2013 | Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indic... | Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pu... | Class I | Animas Corporation |
| Dec 17, 2012 | Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infu... | Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on J... | Class III | Animas Corporation |
| Dec 17, 2012 | Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F... | Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" ne... | Class II | Vygon Corporation |
| Dec 13, 2012 | REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product ... | The affected product was packaged with the incorrect introducer needle. The kit label indicates ... | Class II | Medical Components, Inc dba MedComp |
| Dec 13, 2012 | Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number... | The displayed value for the invasive blood pressure measurement of the IACS was different than th... | Class II | Draeger Medical, Inc. |
| Nov 29, 2012 | Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath ... | Firm became aware that two handsets in the affected batches became inoperable while the user was ... | Class II | Handicare Accessibility |
| Nov 27, 2012 | Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 4... | Potential to have an internal leak at the fill port of the stainless steel tip, which may necessi... | Class II | Arrow International Inc |
| Nov 27, 2012 | Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr ... | Potential to have an internal leak at the fill port of the stainless steel tip, which may necessi... | Class II | Arrow International Inc |
| Nov 27, 2012 | Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syn... | Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" func... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 26, 2012 | Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 i... | In the course of the firm's product monitoring activities, a potential risk for patient or operat... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 5, 2012 | MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardia... | The seal between the white polyethylene and the clear plastic may be missing on the Hand Controll... | Class II | Medrad Inc |
| Nov 2, 2012 | Synthes Trauma Nail System. The devices are indication for bone fixation. | Recall was initiated due to the possibility that the outer pouch was compromised. The product is... | Class II | Synthes USA HQ, Inc. |
| Oct 25, 2012 | Animas Vibe Insulin Infusion Pump and System. These products are indicated... | Animas determined that keypad wear over time was contributing to an increased complaint rate asso... | Class II | Animas Corporation |
| Oct 12, 2012 | Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 ... | A complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch i... | Class II | Synthes USA HQ, Inc. |
| Oct 12, 2012 | Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Num... | It was discovered internally that there was a discrepancy between the insert provided with the Tu... | Class II | Synthes USA HQ, 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.