Browse Device Recalls
61 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 61 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 61 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 20, 2023 | For intraventricular indications mainly used for operations within the brain ... | Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a ... | Class II | Aesculap Implant Systems LLC |
| May 18, 2023 | Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, n... | Incorrect product code marked on the product, etched with product code MD611, however; the correc... | Class II | Aesculap Implant Systems LLC |
| Mar 21, 2023 | Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagul... | Potential for the spring to become loose and fall out of the device, if the spring falls out duri... | Class II | Aesculap Implant Systems LLC |
| Feb 23, 2023 | Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cer... | Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955... | Class II | Aesculap Implant Systems LLC |
| Jul 15, 2022 | Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmenta... | Potential for the incorrect screw to be included in the package. | Class II | Aesculap Implant Systems LLC |
| Jul 14, 2022 | Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Artic... | Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recov... | Class II | Aesculap Implant Systems LLC |
| Oct 25, 2021 | MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium I... | Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation o... | Class II | Aesculap Implant Systems LLC |
| Jun 30, 2021 | LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery. | Customized coronal rod benders may deform the implant when used with the spinal system devices. | Class II | Aesculap Implant Systems LLC |
| Jun 30, 2021 | RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery. | Customized coronal rod benders may deform the implant when used with the spinal system devices. | Class II | Aesculap Implant Systems LLC |
| Apr 16, 2021 | PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13 | Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medica... | Class II | Aesculap Implant Systems LLC |
| Apr 16, 2021 | PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU | Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medica... | Class II | Aesculap Implant Systems LLC |
| Mar 19, 2021 | Univation X System knee implant devices as follows: Catalog/Product: NL482... | Malfunction- loosening of the implant resulting in a potential revision surgery | Class II | Aesculap Implant Systems LLC |
| Mar 19, 2021 | Univation X System knee implant devices as follows: Catalog/Product: NL488... | Malfunction- loosening of the implant resulting in a potential revision surgery | Class II | Aesculap Implant Systems LLC |
| Mar 19, 2021 | Univation X System Tray Sysem knee implant devices as follows: Tray Number/... | Malfunction- loosening of the implant resulting in a potential revision surgery | Class II | Aesculap Implant Systems LLC |
| Mar 19, 2021 | Univation X System knee implant devices as follows: Catalog/Product: NL476... | Malfunction- loosening of the implant resulting in a potential revision surgery | Class II | Aesculap Implant Systems LLC |
| Mar 19, 2021 | Univation X System knee implant devices as follows: Catalog/Product: NO180... | Malfunction- loosening of the implant resulting in a potential revision surgery | Class II | Aesculap Implant Systems LLC |
| Mar 19, 2021 | Univation X System knee implant devices as follows: Catalog/Product: NL494... | Malfunction- loosening of the implant resulting in a potential revision surgery | Class II | Aesculap Implant Systems LLC |
| Mar 19, 2021 | Univation X System knee implant devices as follows: Catalog/Product: NO156... | Malfunction- loosening of the implant resulting in a potential revision surgery | Class II | Aesculap Implant Systems LLC |
| Mar 19, 2021 | Univation X System knee implant devices as follows: Catalog/Product: NL470... | Malfunction- loosening of the implant resulting in a potential revision surgery | Class II | Aesculap Implant Systems LLC |
| Feb 19, 2021 | Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Micro... | Malfunction of the robotic arm preventing further movement of the robotic arm and requiring resta... | Class II | Aesculap Implant Systems LLC |
| Nov 18, 2020 | ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R | Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle... | Class II | Aesculap Implant Systems LLC |
| Sep 8, 2020 | AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, ... | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... | Class II | Aesculap Implant Systems LLC |
| Sep 8, 2020 | AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, p... | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... | Class II | Aesculap Implant Systems LLC |
| Sep 8, 2020 | AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE ... | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... | Class II | Aesculap Implant Systems LLC |
| Sep 8, 2020 | AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE ... | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... | Class II | Aesculap Implant Systems LLC |
| Sep 8, 2020 | AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE ... | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... | Class II | Aesculap Implant Systems LLC |
| Sep 8, 2020 | AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, ... | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... | Class II | Aesculap Implant Systems LLC |
| Jul 13, 2020 | ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R | Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle... | Class II | Aesculap Implant Systems LLC |
| 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 |
| 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 |
| Nov 12, 2019 | ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo... | Nonfunctional key due to the potential for damage to the key pins cause by force of use during as... | Class II | Aesculap Implant Systems LLC |
| Oct 1, 2019 | Aesculap Sterile disposable fleece drape, Product code: GA414, individually p... | Packaging seal integrity not validated resulting in a lack of sterility assurance. | Class II | Aesculap Implant Systems LLC |
| Sep 25, 2019 | AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual ... | Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM. | Class II | Aesculap Implant Systems LLC |
| Aug 7, 2019 | CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrume... | possibility of the sterility batch being insufficiently sterilized | Class II | Aesculap Implant Systems LLC |
| Aug 7, 2019 | CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrum... | possibility of the sterility batch being insufficiently sterilized | Class II | Aesculap Implant Systems LLC |
| Feb 16, 2018 | Doyen-Collin Mouth Gag 120MM/ General Instruments | The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocess... | Class III | Aesculap Implant Systems LLC |
| Feb 16, 2018 | Strauss Penis Clamp 130MM/General Instruments | The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocess... | Class III | Aesculap Implant Systems LLC |
| Jan 22, 2018 | DS Titanium Ligation Clip Appliers, used in laparoscopic surgery | Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added o... | Class II | Aesculap Implant Systems LLC |
| Jan 22, 2018 | DS Titanium Ligation Clip, used in laparoscopic surgery | Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added o... | Class II | Aesculap Implant Systems LLC |
| Sep 21, 2017 | proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System ... | A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct v... | Class II | Aesculap Implant Systems LLC |
| Sep 8, 2017 | JS Series SterilContainer S2 System | The JS Series SterilContainer S2 System was released to the market place prior to an authorized F... | Class II | Aesculap Implant Systems LLC |
| Sep 5, 2017 | ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ... | ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | Class II | Aesculap Implant Systems LLC |
| Sep 5, 2017 | ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ... | ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | Class II | Aesculap Implant Systems LLC |
| Sep 5, 2017 | ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT... | ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | Class II | Aesculap Implant Systems LLC |
| Sep 1, 2017 | The ELAN 4 Air System is intended for high speed cutting, sawing and drilling... | The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance.... | Class II | Aesculap Implant Systems LLC |
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.