Browse Device Recalls
1,092 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,092 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 1,092 FDA device recalls in OH.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Apr 2, 2019 | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L 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 10L 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 |
| Mar 19, 2019 | BIOPHEN UFH Control C2, REF 223901 | The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for t... | Class III | Aniara Diagnostica LLC |
| Mar 19, 2019 | BIOPHEN LMWH Control C4, REF 224201 | The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for t... | Class III | Aniara Diagnostica LLC |
| Mar 19, 2019 | BIOPHEN UFH Control C1, REF 224101 | The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for t... | Class III | Aniara Diagnostica LLC |
| Feb 4, 2019 | US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock... | Potential esophageal laceration during a patient procedure | Class II | US Endoscopy Group Inc |
| Jan 22, 2019 | COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002 | There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... | Class II | AtriCure, Inc. |
| Jan 22, 2019 | COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001 | There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... | Class II | AtriCure, Inc. |
| Jan 22, 2019 | COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S | There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... | Class II | AtriCure, Inc. |
| Jan 22, 2019 | COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI | There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... | Class II | AtriCure, Inc. |
| Jan 4, 2019 | SWIN 2017 database, Model YSW4000 | Potential for out of range microbial results | Class II | Remel Inc. |
| Dec 26, 2018 | ATLAS Loading Car | The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when t... | Class II | Steris Corporation |
| Dec 20, 2018 | AMSCO 3000 Series Washer/Disinfector Model # 3052 | The software in the systems may not process the cycle originally intended. This could result in d... | Class II | Steris Corporation |
| Dec 20, 2018 | AMSCO 5000 Series Washer/Disinfector Model # 5052 | The software in the systems may not process the cycle originally intended. This could result in d... | Class II | Steris Corporation |
| Dec 19, 2018 | Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagn... | A software update is being issued to correct multiple issues identified in the previous software ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 19, 2018 | Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: ... | Evidence supports that when customers performed a fuse replacement as part of a March 2017 field ... | Class II | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Dec 17, 2018 | PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PR... | An enzyme reagent included in the kit is not maintaining stability through claimed product expira... | Class II | Meridian Bioscience Inc |
| Dec 7, 2018 | PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: ... | Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially caus... | Class II | Ethicon Endo-Surgery Inc |
| Dec 7, 2018 | PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: Th... | Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially caus... | Class II | Ethicon Endo-Surgery Inc |
| Nov 30, 2018 | AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for t... | Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh A... | Class II | Tosoh Bioscience Inc |
| Nov 30, 2018 | ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOS... | Class II | Tosoh Bioscience Inc | |
| Nov 30, 2018 | ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY f... | Class II | Tosoh Bioscience Inc | |
| Nov 30, 2018 | ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY f... | Class II | Tosoh Bioscience Inc | |
| Nov 30, 2018 | AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the qu... | Class II | Tosoh Bioscience Inc | |
| Nov 30, 2018 | ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO... | Class II | Tosoh Bioscience 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.