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 |
|---|---|---|---|---|
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 6, 2020 | System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel det... | It was determined that in rare cases persons can receive low dose of unintended radiation. The s... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 6, 2020 | System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat... | It was determined that in rare cases persons can receive low dose of unintended radiation. The s... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 1, 2020 | PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENG... | Endoscopic graspers may become separated at the weld from handle to the shaft of the device. | Class II | Aesculap Implant Systems LLC |
| Apr 1, 2020 | PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LEN... | Endoscopic graspers may become separated at the weld from handle to the shaft of the device. | Class II | Aesculap Implant Systems LLC |
| Mar 26, 2020 | Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing cont... | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Gentell, Inc |
| Mar 26, 2020 | Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydroge... | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Gentell, Inc |
| Mar 26, 2020 | Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing cont... | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Gentell, Inc |
| Mar 26, 2020 | Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing cont... | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Gentell, Inc |
| Mar 23, 2020 | Olympus Pleuravideoscope, Model LTF-240 | There was no data to validate that the identified endo-therapy devices were compatible with certa... | Class II | Olympus Corporation of the Americas |
| Mar 23, 2020 | Olympus Pleuravideoscope, Model LTF-160 | There was no data to validate that the identified endo-therapy devices were compatible with certa... | Class II | Olympus Corporation of the Americas |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product:... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product:... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Mar 6, 2020 | TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 573... | Failure to prime due to an assembly error | Class II | Cardiac Assist, Inc |
| Feb 27, 2020 | Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care ... | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Gentell, Inc |
| Feb 27, 2020 | Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care o... | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Gentell, Inc |
| Feb 27, 2020 | Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a... | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Gentell, Inc |
| Feb 27, 2020 | Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care ... | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Gentell, Inc |
| Feb 18, 2020 | PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versi... | Potential safety issue with the dose monitoring system safety interlocks which could result in a ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2020 | ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console S... | Potential safety issue with the dose monitoring system safety interlocks which could result in a ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2020 | ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #585... | Potential safety issue with the dose monitoring system safety interlocks which could result in a ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2020 | MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, ME... | Potential safety issue with the dose monitoring system safety interlocks which could result in a ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2020 | Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137... | A software issue could potentially cause the stand and table movements to be blocked. | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2020 | Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Ar... | A software issue could potentially cause the stand and table movements to be blocked. | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2020 | Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848... | A software issue could potentially cause the stand and table movements to be blocked. | Class II | Siemens Medical Solutions USA, Inc |
| Feb 10, 2020 | Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray ... | The Ysio system may process incorrect internal values for the position of its ceiling tube stand.... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 24, 2020 | ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 ... | Potential exists for one or more axes of the robotic stand to become blocked by their safety brak... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 21, 2020 | COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes,... | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... | Class II | Aesculap Implant Systems LLC |
| Jan 21, 2020 | AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, ... | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... | Class II | Aesculap Implant Systems LLC |
| Jan 21, 2020 | COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, m... | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... | Class II | Aesculap Implant Systems LLC |
| Jan 21, 2020 | COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, m... | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... | Class II | Aesculap Implant Systems LLC |
| Jan 21, 2020 | Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, m... | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... | Class II | Aesculap Implant Systems LLC |
| Jan 16, 2020 | COHERENCE Oncologist, Model Nos. 07333680 & 07351898 | A potential safety issue arises when an offset calculation is followed by a filter operation; cor... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220 | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code MTO-09903-KU | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501 | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04 | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-0... | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCHH | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-0... | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code CZ-05400-EPI | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International 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.