Browse Device Recalls
2,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,969 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 2,969 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code UR-05501 | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code BE-05400B-ETTEL | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code ALZANO-05400-B | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | 10 cc Luer-Slip Loss of Resistance Syringe, Product Code LR-05501 | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-EXP | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Set, Product Code MP-17019-TIP | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code DE-05400D-BO | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1 | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Set, Product Code AA-05400-E | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Pro... | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code JC-05400-LB | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code IT-05400-DC | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1 | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Cathe... | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 8, 2020 | Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a... | Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in coll... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a d... | Two software issues (1) Using the override function in case of blocked system movements affecting... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a dev... | A software bug may lead to one image to be assigned to two different patients, which could potent... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a dev... | Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in coll... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a... | A software bug may lead to one image to be assigned to two different patients, which could potent... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a... | Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in coll... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is ... | Two software issues (1) Using the override function in case of blocked system movements affecting... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic ... | A software bug may lead to one image to be assigned to two different patients, which could potent... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Mod... | Two software issues (1) Using the override function in case of blocked system movements affecting... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is ... | Two software issues (1) Using the override function in case of blocked system movements affecting... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 20, 2019 | Arrow EPIDURAL NEEDLE COMPONENT AN-05505 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow¿ EPIDURAL CATHETERIZATION KIT AK-05000 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL CATHETERIZATION KIT JH-05500 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL NEEDLE KIT SL-05500 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow SPINAL ANESTHESIA SET ASA-25090-S | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL CATHETERIZATION KIT AM-05500 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow Maximal Barrier Drape ASK-00002-1A | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | (1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ S... | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL CATHETERIZATION KIT CK-02220 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL CATHETERIZATION KIT YC-02220 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow Central Venous Catheterization Kit ASK-04200-UPM | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | PICC Set- PR-35052-HPHNM | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray Sys... | The potential exists for system movement to be permanently blocked by an activation of the collis... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 20, 2019 | Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 16, 2019 | 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - ... | There is a possibility that the inner cap could open when the outer cap is removed or the entire ... | Class II | Synthes, Inc. |
| Dec 16, 2019 | 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - ... | There is a possibility that the inner cap could open when the outer cap is removed or the entire ... | Class II | Synthes, 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.