Browse Device Recalls
1,023 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,023 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 1,023 FDA device recalls — Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 27, 2020 | Albumin Gen.2, Catalog 05166861190 | Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for... | Class III | Roche Diagnostics Operations, Inc. |
| Aug 7, 2020 | Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: In... | Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This d... | Class III | Maquet Cardiovascular Us Sales, Llc |
| Jul 16, 2020 | Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usag... | Incorrect expiration date included in test kit labeling and/or in Substrate component label. | Class III | Oxford Immunotec |
| Jul 16, 2020 | Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usag... | Incorrect expiration date included in test kit labeling and/or in Substrate component label. | Class III | Oxford Immunotec |
| Jul 15, 2020 | Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product... | Unit boxes not properly sealed | Class III | OraSure Technologies, Inc. |
| Jul 15, 2020 | Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 100... | Unit boxes not properly sealed | Class III | OraSure Technologies, Inc. |
| Jul 15, 2020 | CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: ind... | Unit boxes not properly sealed | Class III | OraSure Technologies, Inc. |
| Jul 13, 2020 | Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate... | Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included ... | Class III | OraSure Technologies, Inc. |
| Jul 13, 2020 | Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate ... | Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included ... | Class III | OraSure Technologies, Inc. |
| Jun 24, 2020 | PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1... | Reagents were shipped to customers after the Use by data indicated on its labeling. | Class III | DNA Genotek Inc. |
| Jun 15, 2020 | POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell C... | Convenience kit mislabeled with the incorrect catheter effective length on the device label and t... | Class III | Access Scientific LLC |
| Apr 3, 2020 | Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medulla... | The lot number on the pediatric orthopedic implant driver instrument handle does not match the lo... | Class III | Pega Medical Inc. |
| Apr 3, 2020 | ImmersiveView software version 2.1 Product Usage: ImmersiveView is intend... | Observed an internal repetitive software glitch in ImmersiveView. | Class III | Immersivetouch Inc |
| Apr 1, 2020 | ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnos... | Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide... | Class III | Abbott Laboratories |
| Apr 1, 2020 | ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnos... | Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide... | Class III | Abbott Laboratories |
| Apr 1, 2020 | ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis ... | Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide... | Class III | Abbott Laboratories |
| Mar 20, 2020 | Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm ... | The product has an incorrect reference value for cadmium and an incorrect expected range. | Class III | Utak Laboratories Inc |
| Mar 10, 2020 | VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468 | The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations. | Class III | Ortho Clinical Diagnostics |
| Mar 6, 2020 | AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready... | The UDI on the device label indicates incorrect manufacturer. | Class III | Linet Americas |
| Feb 28, 2020 | Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (1... | Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years. | Class III | CooperSurgical, Inc. |
| Feb 7, 2020 | NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product U... | Nonconforming product which was dispositioned for rejection was mistakenly released for commercia... | Class III | Integra LifeSciences Corp. |
| Jan 16, 2020 | Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Produ... | Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. Th... | Class III | Maquet Cardiovascular Us Sales, Llc |
| Jan 16, 2020 | Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Produ... | Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. Th... | Class III | Maquet Cardiovascular Us Sales, Llc |
| Dec 13, 2019 | Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml | A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Ch... | Class III | Randox Laboratories Ltd. |
| Nov 18, 2019 | LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case | Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specif... | Class III | LivaNova USA Inc. |
| Nov 15, 2019 | AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of ca... | The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack o... | Class III | Tosoh Smd Inc |
| Nov 6, 2019 | Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, St... | The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-... | Class III | Allergan PLC |
| Nov 6, 2019 | Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: ... | The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-... | Class III | Allergan PLC |
| Nov 6, 2019 | Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles an... | The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-... | Class III | Allergan PLC |
| Nov 6, 2019 | NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, ... | The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-... | Class III | Allergan PLC |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System | 905 nm laser diodes may be below rated power output. | Class III | Theralase Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002 | Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and I... | Class III | Theralase Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System | Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-... | Class III | Theralase Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Use... | Device was shipped without a Unique Device Identification (UDI) label and a separate label identi... | Class III | Theralase Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of k... | Device was shipped without a Unique Device Identification (UDI) label. | Class III | Theralase Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the ... | Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple ... | Class III | Theralase Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System | 660 nm laser diodes may be below rated power output. | Class III | Theralase Inc. |
| Sep 23, 2019 | RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066. | Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and sh... | Class III | Randox Laboratories, Limited |
| Sep 18, 2019 | Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples. | The metal cannula of the device either broke and the broken piece left in the blood specimen tube... | Class III | Biomedical Polymers, Inc. |
| Sep 18, 2019 | Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood... | The metal cannula of the device either broke and the broken piece left in the blood specimen tube... | Class III | Biomedical Polymers, Inc. |
| Sep 11, 2019 | Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: I... | Due to low Quality Control recovery and invalid Calibration. | Class III | Roche Diagnostics Operations, Inc. |
| Sep 11, 2019 | Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - ... | Due to low Quality Control recovery and invalid Calibration. | Class III | Roche Diagnostics Operations, Inc. |
| Sep 5, 2019 | Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-8... | The touchpad may not work properly after cleaning. | Class III | CooperSurgical, Inc. |
| Aug 20, 2019 | FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IV... | The firm has identified that an incorrect instruction for use (IFU) revision was included in the ... | Class III | Biofire Defense |
| Aug 19, 2019 | LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical ... | Discrepancy between the correct expiration dates on the individual pouches inside the boxes and i... | Class III | CooperSurgical, Inc. |
| Aug 13, 2019 | EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100... | Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers. | Class III | Baxter Healthcare Corporation |
| Jul 25, 2019 | Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Prod... | Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range wa... | Class III | Randox Laboratories Ltd. |
| Jul 19, 2019 | MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to... | Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause... | Class III | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Jul 12, 2019 | This is an in vitro diagnostic product intended for use as a calibration seru... | Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for AL... | Class III | Randox Laboratories Ltd. |
| Jul 3, 2019 | LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected produc... | Perfusion tubing pack was packaged with the incorrect cuvette. | Class III | LivaNova USA 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.