Browse Device Recalls

1,040 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,040 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 1,040 FDA device recalls, Class III.

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DateProductReasonClassFirm
Sep 21, 2020 3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usag... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usa... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a v... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a v... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usag... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a v... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 14, 2020 MR Coils The MR Coil is intended to be used in conjunction with a Magnetic... The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protect... Class III Invivo Corporation
Sep 7, 2020 Neoprobe GDS Control Unit, Model Number NPCU3 It was discovered during a documentation review that China has the software version as v5.01 appr... Class III Devicor Medical Products Inc
Aug 27, 2020 Tina-quant Complement C4 ver.2, Catalog 05991994190 Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for... Class III Roche Diagnostics Operations, Inc.
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 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 Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product... 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 ImmersiveView software version 2.1 Product Usage: ImmersiveView is intend... Observed an internal repetitive software glitch in ImmersiveView. Class III Immersivetouch Inc
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 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
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
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 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
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
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 905 nm laser diodes may be below rated power output. 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.

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.