Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 8, 2019 | Terumo Needle, 23G x 1", Product Code NN2325R | There is a potential for a loss of package integrity that may compromise the sterility of the pro... | Class II | Terumo Medical Corporation |
| Feb 8, 2019 | Infinity Delta Family patient monitors The Infinity Delta Series (Delta/De... | The firm is recalling their Delta family of patient monitors software due to cybersecurity vulner... | Class II | Draegar Medical Systems, Inc. |
| Feb 8, 2019 | Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280 | There is a potential for a loss of package integrity that may compromise the sterility of the pro... | Class II | Terumo Medical Corporation |
| Feb 7, 2019 | Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product... | The target value for uptake is incorrect on the value sheet for an analyzer. The target value fo... | Class III | Randox Laboratories Ltd. |
| Feb 7, 2019 | Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usag... | The target value for uptake is incorrect on the value sheet for an analyzer. The target value fo... | Class III | Randox Laboratories Ltd. |
| Feb 7, 2019 | Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: ... | The target value for uptake is incorrect on the value sheet for an analyzer. The target value fo... | Class III | Randox Laboratories Ltd. |
| Feb 7, 2019 | Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The gui... | Frayed pieces of the mounting card being inside the primary packaging. | Class III | Cordis Corporation |
| Feb 6, 2019 | LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: ... | The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected thro... | Class II | LW Scientific, Inc. |
| Feb 6, 2019 | Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Mod... | The sound processors were loaded with the incorrect firmware. | Class II | Advanced Bionics, LLC |
| Feb 6, 2019 | LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: ... | The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected thro... | Class II | LW Scientific, Inc. |
| Feb 6, 2019 | Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140. | The sound processors were loaded with the incorrect firmware. | Class II | Advanced Bionics, LLC |
| Feb 6, 2019 | Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical ... | Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfer... | Class II | Medica Corporation |
| Feb 6, 2019 | Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Mod... | The sound processors were loaded with the incorrect firmware. | Class II | Advanced Bionics, LLC |
| Feb 6, 2019 | LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: u... | The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected thro... | Class II | LW Scientific, Inc. |
| Feb 5, 2019 | Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures | Inner blister pack label is incorrect and does not match the correct external box label. | Class III | SPINEART SA |
| Feb 5, 2019 | Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol a... | Patient results may be falsely elevated. This patient impact only applies to patients currently ... | Class II | Abbott Ireland Diagnostics Division |
| Feb 5, 2019 | Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradi... | Patient results may be falsely elevated. This patient impact only applies to patients currently ... | Class II | Abbott Ireland Diagnostics Division |
| Feb 4, 2019 | US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock... | Potential esophageal laceration during a patient procedure | Class II | US Endoscopy Group Inc |
| Feb 4, 2019 | Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per bo... | Potential compromise of product sterility after routine monitoring for Endotoxins showed an out o... | Class II | CP Medical Inc |
| Feb 4, 2019 | Cobas¿ infinity central lab IT solution Material Number: 07154003001 Ca... | Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential ... | Class II | Roche Diagnostics Corporation |
| Feb 4, 2019 | Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 143001... | The firm has received 7 reports of malfunction for the device in which the hooks have broken off,... | Class II | Moller Vital |
| Feb 4, 2019 | EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument ... | The firm has received reports/complaints concerning the breakage of the tips of the locking femo... | Class II | Encore Medical, Lp |
| Feb 4, 2019 | Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 18... | The firm has received 7 reports of malfunction for the device in which the hooks have broken off,... | Class II | Moller Vital |
| Feb 1, 2019 | LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor... | Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after ... | Class I | Physio-Control Inc |
| Feb 1, 2019 | Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. ... | The products were manufactured without a back bevel on the needle tip. This could cause damage to... | Class I | Cook Inc. |
| Feb 1, 2019 | LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(... | Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after ... | Class I | Physio-Control Inc |
| Feb 1, 2019 | NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, ... | Potentially comingled, resulting in the product in the box potentially not matching the product o... | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Feb 1, 2019 | 3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061 | The syringes have scale markings that were printed incorrectly. The scale is skewed to varying de... | Class II | Becton Dickinson & Company |
| Feb 1, 2019 | NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, ... | Potentially comingled, resulting in the product in the box potentially not matching the product o... | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Feb 1, 2019 | 3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573 | The syringes have scale markings that were printed incorrectly. The scale is skewed to varying de... | Class II | Becton Dickinson & Company |
| Jan 31, 2019 | Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use | Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 mo... | Class II | Microbiologics Inc |
| Jan 31, 2019 | Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile,... | The product was mislabeled with an incorrect expiration date. | Class II | RHONDIUM LIMITED |
| Jan 31, 2019 | Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR... | Potential for the Semi-Rigid canister lid to fragment during use. | Class II | Medline Industries Inc |
| Jan 30, 2019 | OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore... | Product mislabeling. | Class II | Matrix Surgical Holdings, LLC |
| Jan 30, 2019 | Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TS... | The vertical dimensions of screw-hole position in some standalone cages might be out of range in ... | Class II | U&I CORP. |
| Jan 30, 2019 | OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore... | Product mislabeling. | Class II | Matrix Surgical Holdings, LLC |
| Jan 29, 2019 | TASE 500 Imaging systems | the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized i... | Class II | COLLINS AEROSPACE |
| Jan 29, 2019 | TASE 400 Imaging systems | the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized i... | Class II | COLLINS AEROSPACE |
| Jan 28, 2019 | Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: ... | The product may not have met sterility requirements . Use of a non-sterile device on a patient m... | Class II | Applied Medical Resources Corp |
| Jan 28, 2019 | ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens M... | The action is being initiated due to internal testing which identified a possibility for transduc... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 28, 2019 | LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOn... | Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Speci... | Class III | LivaNova USA Inc. |
| Jan 28, 2019 | ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Si... | The action is being initiated due to internal testing which identified a possibility for transduc... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 28, 2019 | Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the... | Several reports were received that patient records were printed with the correct patient demograp... | Class II | Spacelabs Healthcare, Inc. |
| Jan 28, 2019 | ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens ... | The action is being initiated due to internal testing which identified a possibility for transduc... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 28, 2019 | ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Sie... | The action is being initiated due to internal testing which identified a possibility for transduc... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 25, 2019 | Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF:... | Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturin... | Class II | Philips North America, LLC |
| Jan 25, 2019 | INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425 | Products were distributed with the incorrect instructions for use. | Class III | AAP Implantate Ag |
| Jan 25, 2019 | Obturator (shortcone), Part number 26114 Product Usage: The obturator is ... | The weld may break, resulting in the rod separating from the cone of the long and short cone Obtu... | Class II | Medrobotics Corporation |
| Jan 25, 2019 | INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453 | Products were distributed with the incorrect instructions for use. | Class III | AAP Implantate Ag |
| Jan 25, 2019 | PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, ... | Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibi... | Class III | Agfa N.V. |
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.