Browse Device Recalls
1,067 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,067 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 1,067 FDA device recalls in OH.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 3, 2019 | PediaLift Access Device, Device Identifier: B751PDLFT0 | The firm was unsuccessful in obtaining a satisfactory Certificate of Conformance from the origi... | Class II | PediaLift LLC |
| Jul 2, 2019 | Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage... | Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue ... | Class II | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Jul 2, 2019 | Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature ... | Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue ... | Class II | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Jul 2, 2019 | CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool ... | Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue ... | Class II | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Jun 24, 2019 | IQon Spectral CT Model # 728332, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Vereos PET/CT Model # 882446, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Ingenuity Core Model # 728321, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | iCT SP Model # 728311, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Ingenuity CT, Model # 728326, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | iCT, Model # 728306, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Brilliance 64 Model # 728231, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Ingenuity Core128 Model # 728323, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 20, 2019 | Norm-O-Temp model 111W | The manual does not provide instruction stating that exceeding 40 Celsius for extended periods ca... | Class II | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Jun 20, 2019 | Norm-O-Temp model 111Z | The manual does not provide instruction stating that exceeding 40 Celsius for extended periods ca... | Class II | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Jun 10, 2019 | VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory in... | Lack of package integrity may compromise sterility | Class II | Santanello Surgical LLC |
| Jun 10, 2019 | BrightView X , Model Number 882478 | An issue with the handcontroller may result in either spontaneous uncommanded motions or continue... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 10, 2019 | BrightView SPECT, Model Number 882480 | An issue with the handcontroller may result in either spontaneous uncommanded motions or continue... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 10, 2019 | BrightView XCT , Model Number 882482 | An issue with the handcontroller may result in either spontaneous uncommanded motions or continue... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 3, 2019 | Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomograp... | The Vereos PET/CT may have misaligned front and rear covers, which may result in gaps between cov... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 29, 2019 | EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Produ... | The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has ... | Class II | AtriCure, Inc. |
| May 15, 2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C | Observed reported incidence rate for harm associated with intraoperative bleeding | Class II | Ethicon Endo-Surgery Inc |
| May 15, 2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C | Observed reported incidence rate for harm associated with intraoperative bleeding | Class II | Ethicon Endo-Surgery Inc |
| May 15, 2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C | Observed reported incidence rate for harm associated with intraoperative bleeding | Class II | Ethicon Endo-Surgery Inc |
| Apr 16, 2019 | Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alva... | Foreign Material in the Alvarado Knee Holder Base Plate Assembly and Foot Piece and Alvarado II B... | Class II | Zimmer Surgical Inc |
| Apr 11, 2019 | Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon End... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon End... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon End... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon End... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 8, 2019 | MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, ... | Product design change did not receive proper premarket clearance and lacks a 510 (k) | Class II | Compass Health Brands (Corporate Office) |
| Apr 8, 2019 | MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, M... | Product design change did not receive proper premarket clearance and lacks a 510 (k) | Class II | Compass Health Brands (Corporate Office) |
| Apr 8, 2019 | MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Mo... | Product design change did not receive proper premarket clearance and lacks a 510 (k) | Class II | Compass Health Brands (Corporate Office) |
| Apr 8, 2019 | MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, ... | Product design change did not receive proper premarket clearance and lacks a 510 (k) | Class II | Compass Health Brands (Corporate Office) |
| Apr 8, 2019 | MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, M... | Product design change did not receive proper premarket clearance and lacks a 510 (k) | Class II | Compass Health Brands (Corporate Office) |
| Apr 8, 2019 | MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #... | Product design change did not receive proper premarket clearance and lacks a 510 (k) | Class II | Compass Health Brands (Corporate Office) |
| Apr 2, 2019 | Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bat... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Thermo Scientific General Purpose Dynamic Bath Precision 28L GP Bath Model... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath ... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath Model N... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath ... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath ... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
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.