Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Ca... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | GS0008 2Y - Burn Pack - STL, Item Number 880082025 | Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 ... | Class II | ROi CPS LLC |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Ca... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Ca... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Ca... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catal... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catal... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catal... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 8, 2023 | Centricity Universal Viewer Workflow Manager, Image processing radiological s... | When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a thir... | Class II | GE Healthcare |
| Sep 8, 2023 | Universal Viewer Workflow Manager, Image processing radiological system | When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a thir... | Class II | GE Healthcare |
| Sep 8, 2023 | F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) | There is a potential interruption of data communication between E-modules inserted in the F2-01 F... | Class II | GE Medical Systems China Co., Ltd. |
| Sep 8, 2023 | Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-... | An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower b... | Class II | Omega Medical Imaging, Inc. |
| Sep 7, 2023 | Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software ve... | CORI software was missing a planning stage that appears in cases of significant knee deformation ... | Class II | Blue Belt Technologies, Inc |
| Sep 7, 2023 | Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARAC... | Custom surgical procedure packs contain latex gloves but are labeled as "latex free". | Class II | Alcon Research, LLC |
| Sep 7, 2023 | Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 | Inadvertent release of embolectomy catheters that may experience slower than normal balloon defla... | Class II | Edwards Lifesciences, LLC |
| Sep 6, 2023 | Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2,... | Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adju... | Class II | GE MEDICAL SYSTEMS, ISRAEL LTD. |
| Sep 6, 2023 | RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical sho... | Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver | Class II | Encore Medical, LP |
| Sep 6, 2023 | RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000 | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... | Class II | Randox Laboratories Ltd. |
| Sep 6, 2023 | RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (re... | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... | Class II | Randox Laboratories Ltd. |
| Sep 6, 2023 | RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000 | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... | Class II | Randox Laboratories Ltd. |
| Sep 6, 2023 | Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gase... | The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the pa... | Class II | Smiths Medical ASD Inc. |
| Sep 6, 2023 | RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: R... | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... | Class II | Randox Laboratories Ltd. |
| Sep 6, 2023 | AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solu... | The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU)... | Class II | Beckman Coulter Biomedical Division |
| Sep 6, 2023 | RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (... | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... | Class II | Randox Laboratories Ltd. |
| Sep 6, 2023 | BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wi... | When global edit is used to update multiple formulary properties simultaneously, the following pr... | Class II | CareFusion 303, Inc. |
| Sep 6, 2023 | Meera Mobile Operating Table-to support and position the patient immediately ... | Under certain conditions, an issue might prevent the device from performing as intended. A specif... | Class II | Getinge Usa Sales Inc |
| Sep 5, 2023 | Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the d... | Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at... | Class II | Zimmer Surgical Inc |
| Sep 5, 2023 | MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 ... | Software update | Class II | Mazor Robotics Ltd |
| Sep 5, 2023 | Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN... | Product was re-processed and re-sterilized by a third party using packaging configurations and a ... | Class II | Atrium Medical Corporation |
| Sep 5, 2023 | Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN... | Product was re-processed and re-sterilized by a third party using packaging configurations and a ... | Class II | Atrium Medical Corporation |
| Sep 1, 2023 | LAVH, REF BBLV21C | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Robotics Pack SAH, REF SAR530M | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100... | Potential for breach of Tyvek seals. | Class II | Onkos Surgical, Inc. |
| Sep 1, 2023 | Robotics Pack, REF SJVO56B | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-0... | Potential for breach of Tyvek seals. | Class II | Onkos Surgical, Inc. |
| Sep 1, 2023 | Breast Plastics Pack, REF BBPL20D | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Pediatric Urology Wolson Pack, REF BPPU55A | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | General Pack, REF BBGP31C | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, ... | Potential for breach of Tyvek seals. | Class II | Onkos Surgical, Inc. |
| Sep 1, 2023 | Male-Female Midsection with the following sizes and model numbers. a. Male... | Potential for breach of Tyvek seals. | Class II | Onkos Surgical, Inc. |
| Sep 1, 2023 | Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-0... | Potential for breach of Tyvek seals. | Class II | Onkos Surgical, Inc. |
| Sep 1, 2023 | CVS PCSU SJH, REF SJCV48J | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Pediatric Heart SJH, REF SJPH34K | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Cath Cardiac Pack, REF IHCC03V | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Numb... | Device reaching End of Service prematurely. | Class II | Angel Medical Systems, Inc. |
| Sep 1, 2023 | Robotics Pack, REF SSRO22D | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNE... | In some cases, when lubricating grease is present within the headband of the over-ear headphones... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 1, 2023 | Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-111... | Potential for breach of Tyvek seals. | Class II | Onkos Surgical, Inc. |
| Sep 1, 2023 | Vasc. Open CVOR SJH, REF SJVO56B | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-0... | It has been found that potential unintended laser activation can occur without foot pedal depress... | Class II | Convergent Dental |
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.