Browse Device Recalls
87 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 87 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 87 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 15, 2021 | Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Des... | To ensure sterilization effectiveness, sterilization tray instructions for use were updated and n... | Class II | Karl Storz Endoscopy |
| Sep 10, 2021 | FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 0... | During a regular requalification review, affected flexible intubation video endoscopes did not ac... | Class II | Karl Storz Endoscopy |
| Jul 27, 2020 | Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual:... | Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... | Class II | Karl Storz Endoscopy |
| Jul 27, 2020 | Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual:... | Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... | Class II | Karl Storz Endoscopy |
| Jul 27, 2020 | Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual:... | Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... | Class II | Karl Storz Endoscopy |
| Jul 27, 2020 | Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual:... | Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... | Class II | Karl Storz Endoscopy |
| Jul 27, 2020 | Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z184... | Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... | Class II | Karl Storz Endoscopy |
| Jul 27, 2020 | Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z184... | Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... | Class II | Karl Storz Endoscopy |
| Jul 27, 2020 | Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual:... | Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... | Class II | Karl Storz Endoscopy |
| Jul 27, 2020 | Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z184... | Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... | Class II | Karl Storz Endoscopy |
| Dec 6, 2019 | Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following R... | The firm has become aware that there is a potential that the glass cover at the distal end of the... | Class II | Karl Storz Endoscopy |
| Aug 27, 2019 | Karl Storz, Model # 11161C2, Flexible Neuroscope | During a complaint investigation it was determined that an error was observed within the instruc... | Class II | Karl Storz Endoscopy |
| Aug 27, 2019 | Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1 | During a complaint investigation it was determined that an error was observed within the instruc... | Class II | Karl Storz Endoscopy |
| Aug 27, 2019 | Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope | During a complaint investigation it was determined that an error was observed within the instruc... | Class II | Karl Storz Endoscopy |
| Apr 24, 2019 | Flexible Intubation Fiberscope, Model # 11301AB1 | The action is being initiated due to intubation scopes improperly manufactured with a double por... | Class II | Karl Storz Endoscopy |
| Feb 20, 2019 | FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1 | The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channe... | Class II | Karl Storz Endoscopy |
| Jan 9, 2019 | Insufflation tubing to be used with varies insufflator units. REF 031200-10; ... | The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable... | Class III | Karl Storz Endoscopy |
| Oct 10, 2017 | STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (out... | The label outside the cardboard box is labeled correctly but the pouches inside of some of the bo... | Class II | Karl Storz Endoscopy |
| Jun 20, 2016 | Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when ... | Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera h... | Class II | Karl Storz Endoscopy |
| Jun 25, 2014 | Essential NEO, Audio/Visual Integration Unit An audio/visual integration u... | KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable cou... | Class II | Karl Storz Endoscopy |
| Nov 13, 2013 | Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD... | KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Int... | Class II | Karl Storz Endoscopy America Inc |
| Nov 13, 2013 | Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009B... | KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Int... | Class II | Karl Storz Endoscopy America Inc |
| Nov 6, 2013 | Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeo... | KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper w... | Class II | Karl Storz Endoscopy America Inc |
| May 31, 2013 | 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUS... | Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the... | Class II | Karl Storz Endoscopy America Inc |
| Aug 16, 2012 | KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manual... | The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. ele... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, c... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. ... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. ele... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode,... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. elect... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. elect... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories ... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. e... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. el... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessorie... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America Inc |
| Jun 1, 2009 | Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electro... | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... | Class II | Karl Storz Endoscopy America 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.