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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.

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DateProductReasonClassFirm
Oct 16, 2019 Quantam 2000 Electrosurgical Generator, Part number 909075. Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 90907... Class II CooperSurgical, Inc.
Oct 16, 2019 i-STAT cTnI cartridge i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. T... Class II Abbott Point Of Care Inc.
Oct 16, 2019 Quantam 2000 Electrosurgical Generator, Part number 909075-05W. Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 90907... Class II CooperSurgical, Inc.
Oct 15, 2019 CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0 There is a potential that an image from a previous patient study to show up in a later patient s... Class II Cuattro LLC
Oct 14, 2019 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used... Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Uri... Class II Ortho Clinical Diagnostics Inc
Oct 14, 2019 Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dil... Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Uri... Class II Ortho Clinical Diagnostics Inc
Oct 14, 2019 Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Labe... Due to the potential for fluid ingress into the Arm which could affect the device's electrical sy... Class II Mizuho OSI
Oct 14, 2019 BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547 Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being... Class II Becton Dickinson & Company
Oct 14, 2019 BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canad... Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being... Class II Becton Dickinson & Company
Oct 14, 2019 Radiofrequency Grounding Pad, REF RF-DGP-L Affected lots were manufactured with the protective release liner in an incorrect orientation. W... Class II Abbott Medical
Oct 11, 2019 Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex M... Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical... Class II TELEFLEX MEDICAL INC
Oct 11, 2019 Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex M... Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical... Class II TELEFLEX MEDICAL INC
Oct 11, 2019 Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000 The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may ... Class II Stryker Communications
Oct 11, 2019 Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe Omn... Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... Class I GE Healthcare, LLC
Oct 11, 2019 Giraffe Incubator infant warmer Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... Class I GE Healthcare, LLC
Oct 11, 2019 Giraffe OmniBed infant warmer Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... Class I GE Healthcare, LLC
Oct 11, 2019 MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042 Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 ma... Class II AMD Medicom Inc.
Oct 11, 2019 MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040 Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 ma... Class II AMD Medicom Inc.
Oct 11, 2019 Synchromed II programmable pump, Model numbers 8637-20 and 8637-40 There is a potential for the presence of a foreign particle inside the pump motor assembly which ... Class I Medtronic Neuromodulation
Oct 11, 2019 ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - Product ... Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system ha... Class II LIFELINES NEURO COMPANY
Oct 11, 2019 Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions... On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Mult... Class II Siemens Healthcare Diagnostics, Inc.
Oct 11, 2019 The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two ... Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO s... Class II Nucryo Vascular Inc.
Oct 11, 2019 Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, S... Through a customer complaint and and internal investigation it was determined that some implant p... Class II Implant Direct Sybron Manufacturing LLC
Oct 11, 2019 Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... Class I GE Healthcare, LLC
Oct 11, 2019 ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usag... Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system ha... Class II LIFELINES NEURO COMPANY
Oct 10, 2019 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase... Firm has identified product has no staining. If used, may result in invalid test results when use... Class II Biocare Medical, LLC
Oct 10, 2019 SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 472358... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item N... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 3285... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 3... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 010055... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 002348... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 0057... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Metasul Taper Liner, various sizes, Item Nos. 00877000528 00877000628 00877... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Periarticular locking plate elbow-sterile, Item Nos. 47235800503 4723580050... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 002232... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 010029605... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 472... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Steri... Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL0... Class II Trilliant Surgical, LLC
Oct 10, 2019 NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 0058500... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 4724931801... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 4723571... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, 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.