Bayer Medical Care, Inc.
Complete recall history across all FDA and CPSC categories — 8 total recalls
Bayer Medical Care, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (8)
FDA medical device enforcement actions by Bayer Medical Care, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 30, 2022 | Source Administration Set (SAS) used with the Medrad Intego PET Infusion Syst... | Black specks may be present on the packaged needles | Class II |
| Sep 14, 2021 | The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syr... | Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR... | Class II |
| Oct 5, 2020 | Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Sy... | Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and... | Class II |
| Dec 14, 2018 | MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjun... | If the head mount knob is not properly tightened and the operator directly us... | Class II |
| Sep 7, 2018 | Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administr... | Bayer has received reports of loose particulate in the filter when the dust c... | Class II |
| Jun 28, 2018 | Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Cat... | The torque wrench used on the ceiling column assembly during a recent service... | Class II |
| Jun 28, 2018 | Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Cat... | The torque wrench used on the ceiling column assembly during a recent service... | Class II |
| Jun 28, 2018 | Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with... | The torque wrench used on the ceiling column assembly during a recent service... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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